BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Start 29 Nov 2023 · End 25 Sep 2025 · Status Ended · 3 EU/EEA countries · 14 sites · Protocol AT-1501-K207

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ended

Participants planned 192

Countries 3

Sites 14

Prophylaxis of Renal Allograft Rejection

To assess the graft function at 12 months post-transplant in tegoprubart treated participants compared to tacrolimus treated participants.

Key facts

Sponsor: Eledon Pharmaceuticals Inc.
Participant type: Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]
Trial duration: 29 Nov 2023 → 25 Sep 2025
Decision date (initial): 2023-11-02
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: Eledon Pharmaceuticals, Inc

External identifiers

EU CT number: 2023-503336-41-00
WHO UTN: U1111-1278-5225

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Prophylaxis, Efficacy, Safety

To assess the graft function at 12 months post-transplant in tegoprubart treated participants compared to tacrolimus treated participants.

Secondary objectives 5

To assess the safety and tolerability of immunomodulation with tegoprubart, in combination with rabbit anti-thymocyte globulin (rATG), and mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) and corticosteroids (CS) as compared to standard of care (SOC) (rATG + MMF/MPS + CS + tacrolimus);
To assess the rate of graft functional impairment at 12 months in tegoprubart treated participants compared to tacrolimus treated participants;
To assess the rate of biopsy proven acute rejection (BPAR) at 12 months post- transplant in tegoprubart treated participants compared to tacrolimus treated participants;
To evaluate the incidence of new onset diabetes mellitus after transplant (NODAT) at 12 months in tegoprubart treated participants compared to tacrolimus treated participants;
To assess overall patient and graft survival at 12 months post-transplant in tegoprubart treated participants compared to tacrolimus treated participants.

Conditions and MedDRA coding

Prophylaxis of Renal Allograft Rejection

Version	Level	Code	Term	System organ class
20.0	PT	10023439	Kidney transplant rejection	100000004870

Study design 3 periods

#	Title	Allocation	Blinding	Arms
1	Screening (Day-28 to 0) This is a phase 2, randomized, multicenter, open-label, active control study to assess the safety and efficacy of tegoprubart compared with tacrolimus in the preservation of allograft function after kidney transplantation. Approximately 120 de novo kidney transplant participants will be randomized. The study will consist of three periods: Screening (Day-28 to 0). Transplant (Day 0). Post-transplant Treatment (Day 1 through Month 12, or Month 13 for participants that do not continue into the Extension study). Prospective participants may be screened within 28 days (inclusive) prior to undergoing a kidney transplant from a living or deceased donor. It is required that the first 10 participants enrolled be recipients of deceased donor kidney transplants.	Randomised Controlled	None
2	Transplant (Day 0) This is a phase 2, randomized, multicenter, open-label, active control study to assess the safety and efficacy of tegoprubart compared with tacrolimus in the preservation of allograft function after kidney transplantation. Approximately 120 de novo kidney transplant participants will be randomized. The study will consist of three periods: Screening (Day-28 to 0). Transplant (Day 0). Post-transplant Treatment (Day 1 through Month 12, or Month 13 for participants that do not continue into the Extension study). Prospective participants may be screened within 28 days (inclusive) prior to undergoing a kidney transplant from a living or deceased donor. It is required that the first 10 participants enrolled be recipients of deceased donor kidney transplants.	Randomised Controlled	None
3	Post-transplant Treatment (Day 1 through Month 12, or Month 13) This is a phase 2, randomized, multicenter, open-label, active control study to assess the safety and efficacy of tegoprubart compared with tacrolimus in the preservation of allograft function after kidney transplantation. Approximately 120 de novo kidney transplant participants will be randomized. The study will consist of three periods: Screening (Day-28 to 0). Transplant (Day 0). Post-transplant Treatment (Day 1 through Month 12, or Month 13 for participants that do not continue into the Extension study). Prospective participants may be screened within 28 days (inclusive) prior to undergoing a kidney transplant from a living or deceased donor. It is required that the first 10 participants enrolled be recipients of deceased donor kidney transplants.	Randomised Controlled	None	Arm A (Investigative Arm) Tegoprubart 20 mg/kg: rATG: 1.5 mg/kg/dose IV for 4 doses (total of 6 mg/kg). The first dose should be started prior to revascularization and the remaining 3 doses (total 4.5 mg/kg) should be given within 5-10 days posttransplant consistent with labeled instructions. Corticosteroid: Tapered to 5 mg by day 28 and to 0 mg by day 196. MMF: 1000 mg BID or MPS: 720 mg BID.Tegoprubart: 20 mg/kg via IV infusion on Days 1, 3, 7, 14, 21, 28 and every 21 days thereafter. Arm B (Control Arm) Tacrolimus: rATG: 1.5 mg/kg/dose IV for 4 doses (total of 6 mg/kg). The first dose should be started prior to revascularization and the remaining 3 doses (total 4.5 mg/kg) should be given within 5-10 days post transplant consistent with labeled instructions. Corticosteroid: Tapered to 5 mg by day 28 and to 0 mg by day 196. MMF: 1000 mg BID or MPS: 720 mg BID.Tacrolimus: Whole blood trough concentration of 6-12 ng/mL until Month 6 and 6-8 ng/mL thereafter. Tacrolimus must be initiated within 48 hours of transplant or when serum creatinine ≤ 4 mg/dL (whichever comes first).

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

Participants meeting all of the following criteria at the time of Screening will be considered for admission to the study: Able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent;
Male or female ≥ 18 years of age;
Recipient of their first kidney transplant from a living or deceased donor;
Willing and able to comply with the study requirements including prohibited concomitant medication restrictions;
Agree not to participate in another interventional study while on treatment;
If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a serum pregnancy test is negative at screening/baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from Screening, through 120 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 12.
If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 120 days after last administration of the study drug and agree to not donate sperm for 120 days after last administration of the study drug;

Exclusion criteria 28

A patient who meets any of the following criteria will be excluded from this study: Induction therapy, other than study-assigned rATG, planned as part of initial immunosuppressive regimen;
History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation or long-term antiplatelet medication
Recipient or donor is seropositive for human immunodeficiency virus (HIV), hepatitis B (HBV) surface antigen, or HBV core antibody or Hepatitis C (HCV). For HCV, a positive HCV antibody test is exclusionary unless the recipient is known to have been treated for HCV, in which case HCV RNA can be measured, and the recipient would only be excluded if HCV RNA positive;
Current calculated panel reactive antibody (cPRA) > 80%;
Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully;
Elevate daspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels greater than 3 times the upper value of the normal range at screening and impaired liver function;
Current or history of active tuberculosis infection. Laboratory evidence of infection (positive PPD or QuantiFERON-TB Gold) in the absence of clinical infection is exclusionary unless the patient has completed treatment as recommended by local authorities; a. Participants with documented Bacillus CalmetteGuerin (BCG) vaccination and a negative chest x-ray may be included at the Investigator’s discretion;
Concurrent participation in another interventional study or treatment with an investigational drug up to 30 days or 5 half-lives (depending on medication and whatever is longer) prior to Screening;
Treatment with an immunologic biologic compound (i.e., tumor necrosis factor inhibitors, [e.g., etanercept, adalimumab], intravenous immunoglobulin) within 90 days of Screening;
Known hypersensitivity to tegoprubart, tacrolimus, mycophenolate, rATG, corticosteroids, or any of their components;
Active substance abuse within 1 year prior to Screening;
Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies;
Clinically significant abnormal ECG at Screening;
Recipient is seronegative for EBV at Screening;
Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening;
Thrombocytopenia (platelets < 75,000 per mm 3), leukopenia (white blood cells [WBC] < 3,000 per mm 3), or anemia (hemoglobin < 8 g/dL) at Screening;
Desensitization therapy within 6 months of transplant;
Pregnancy or breastfeeding;
Unlikely to comply with the visits scheduled in the protocol, in the opinion of the Investigator;
Active coronavirus disease 2019 (COVID-19) infection at time of Screening or a recent history of COVID infection within 30 days prior to enrollment.
Currently treated with corticosteroids other than topical or inhaled corticosteroids;
Previous treatment with tegoprubart or any other anti-CD40L treatment.
Previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi-organ or dual-kidney transplant;
Will receive a kidney with an anticipated cold ischemia time of > 30 hours;
Will receive a kidney from a donor that meets any of the following: Donation after Cardiac Death (DCD) criteria; Or Kidney Donor Profile Index (KDPI) of > 85%; Or Is blood group (ABO) incompatible;
History of any other acute or chronic medical condition, psychiatric disorder or pre-planned medical/surgical procedure that, in the opinion of the Investigator, would compromise the safety of the patient or the integrity of study results;
Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants;
Recipient of an organ from an HLA identical living related donor.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The mean estimated glomerular filtration rate (eGFR) at 12 months.

Secondary endpoints 5

The rate of graft functional impairment at 12 months. A participant is considered to have graft functional impairment if they either: A) Have an eGFR <60 mL/min/1.73m2 or B) Have a decrease in eGFR ≥ 10 mL/min/1.73m2 from Month 1 to Month 12;
The rate of NODAT at 12 months post-transplant;
The rate of patient and graft survival at 12 months post-transplant. Patient and graft survival are defined as either A) Death, B) Re-transplantation or C) Requirement for regular dialysis;
Rate of BPAR-free patient and graft survival at 12 months post-transplant;
Rate of BPAR at 12 months.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

AT-1501 190 mg Vial

PRD10254344 · Product

Active substance: AT-1501
Pharmaceutical form: VIAL FOR INTRAVENOUS USE
Route of administration: INTRAVENOUS
Max daily dose: 20 mg/kg milligram(s)/kilogram
Max total dose: 66 g gram(s)
Max treatment duration: 365 Day(s)
Authorisation status: Not Authorised
MA holder: ELEDON PHARMACEUTICALS, INC.
Paediatric formulation: No
Orphan designation: No

AT-1501 475 mg Vial

PRD11387429 · Product

Active substance: Tegoprubart
Substance synonyms: AT-1501, Humanised IgG1k (C220S/C226S/C229S/P238S) monoclonal antibody against CD40L
Pharmaceutical form: VIAL FOR INTRAVENOUS USE
Route of administration: INTRAVENOUS
Max daily dose: 20 mg/kg milligram(s)/kilogram
Max total dose: 66 g gram(s)
Max treatment duration: 365 Day(s)
Authorisation status: Not Authorised
MA holder: ELEDON PHARMACEUTICALS, INC.
Paediatric formulation: No
Orphan designation: No

Comparator 4

Prograf 0.5 mg hard capsules

PRD324808 · Product

Active substance: Tacrolimus
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 0.1 mg/kg milligram(s)/kilogram
Max total dose: 36.5 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AD02 — -
Marketing authorisation: PA 1241/14/1
MA holder: ASTELLAS PHARMA CO. LTD.
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prograf 5 mg hard capsules

PRD324812 · Product

Active substance: Tacrolimus
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 0.1 mg/kg milligram(s)/kilogram
Max total dose: 36.5 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AD02 — -
Marketing authorisation: PA 1241/14/3
MA holder: ASTELLAS PHARMA CO. LTD.
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prograf 5 mg/ml concentrate for solution for infusion

PRD324813 · Product

Active substance: Tacrolimus
Pharmaceutical form: CONCENTRATE FOR SOLUTION FOR INFUSION
Route of administration: ORAL
Max daily dose: 0.1 mg/kg milligram(s)/kilogram
Max total dose: 36.5 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AD02 — -
Marketing authorisation: PA 1241/14/4
MA holder: ASTELLAS PHARMA CO. LTD.
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prograf 1 mg hard capsules

PRD324809 · Product

Active substance: Tacrolimus
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 0.1 mg/kg milligram(s)/kilogram
Max total dose: 36.5 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AD02 — -
Marketing authorisation: PA 1241/14/2
MA holder: ASTELLAS PHARMA CO. LTD.
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 11

Thymoglobuline 25mg Powder for Solution for Infusion

PRD441258 · Product

Active substance: Antithymocyte Immunoglobulin
Pharmaceutical form: POWDER FOR SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 1.50 mg/kg milligram(s)/kilogram
Max total dose: 6.00 mg/kg milligram(s)/kilogram
Max treatment duration: 10 Week(s)
Authorisation status: Authorised
ATC code: L04AA04 — ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)
Marketing authorisation: PA 611/3/1
MA holder: GENZYME EUROPE B.V.
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prednisolone 5 mg Tablets

PRD9484340 · Product

Active substance: Prednisolone
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 5.00 mg milligram(s)
Max total dose: 770.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: H02A, H02AB06 — CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN, PREDNISOLONE
Marketing authorisation: AA1045/04401
MA holder: CLONMEL HEALTHCARE LTD.
MA country: Malta
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CellCept 1 g/5 ml powder for oral suspension

PRD2159860 · Product

Active substance: Mycophenolate Mofetil
Pharmaceutical form: ORAL SUSPENSION
Route of administration: ORAL
Max daily dose: 1000.00 mg milligram(s)
Max total dose: 1000.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: EU/1/96/005/006
MA holder: ROCHE REGISTRATION GMBH
MA country: Liechtenstein
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CellCept 250 mg capsules

PRD2153966 · Product

Active substance: Mycophenolate Mofetil
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 1000.00 mg milligram(s)
Max total dose: 1000.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: EU/1/96/005/003
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CellCept 500 mg powder for concentrate for solution for infusion

PRD2153967 · Product

Active substance: Mycophenolate Mofetil
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: ORAL
Max daily dose: 1000.00 mg milligram(s)
Max total dose: 1000.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: EU/1/96/005/005
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CellCept 250 mg capsules

PRD2153965 · Product

Active substance: Mycophenolate Mofetil
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 1000.00 mg milligram(s)
Max total dose: 1000.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: EU/1/96/005/001
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CellCept 250 mg capsules

PRD8720514 · Product

Active substance: Mycophenolate Mofetil
Pharmaceutical form: CAPSULE, HARD
Route of administration: ORAL
Max daily dose: 1000.00 mg milligram(s)
Max total dose: 1000.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: EU/1/96/005/007
MA holder: ROCHE REGISTRATION GMBH
MA country: EU
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CellCept 500 mg film-coated tablets

PRD2153968 · Product

Active substance: Mycophenolate Mofetil
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 1000.00 mg milligram(s)
Max total dose: 1000.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: EU/1/96/005/002
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

CellCept 500 mg film-coated tablets

PRD2153969 · Product

Active substance: Mycophenolate Mofetil
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL
Max daily dose: 1000.00 mg milligram(s)
Max total dose: 1000.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: EU/1/96/005/004
MA holder: ROCHE REGISTRATION GMBH
MA country: Iceland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Myfortic 360 mg gastro-resistant tablets

PRD6476771 · Product

Active substance: Mycophenolic Acid
Pharmaceutical form: GASTRO-RESISTANT TABLET
Route of administration: ORAL
Max daily dose: 720.00 mg milligram(s)
Max total dose: 720.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: PA0896/023/002
MA holder: NOVARTIS IRELAND LIMITED
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Myfortic 180 mg gastro-resistant tablets

PRD6476770 · Product

Active substance: Mycophenolic Acid
Pharmaceutical form: GASTRO-RESISTANT TABLET
Route of administration: ORAL
Max daily dose: 720.00 mg milligram(s)
Max total dose: 720.00 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: L04AA06 — MYCOPHENOLIC ACID
Marketing authorisation: PA0896/023/001
MA holder: NOVARTIS IRELAND LIMITED
MA country: Ireland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eledon Pharmaceuticals Inc.

Sponsor organisation: Eledon Pharmaceuticals Inc.
Address: 19900 Macarthur Boulevard Suite 550
City: Irvine
Postcode: 92612-8426
Country: United States

Scientific contact point

Organisation: Eledon Pharmaceuticals Inc.
Contact name: Chief Regulatory Officer

Public contact point

Organisation: Eledon Pharmaceuticals Inc.
Contact name: Clinical Operations

Third parties 4

Organisation	City, country	Duties
Scout Clinical ORG-100042228	Dallas, United States	Other
Icon Clinical Research Limited ORG-100008322	Dublin 18, Ireland	On site monitoring, Code 10, Code 11, Code 12, Code 13, Interactive response technologies (IRT), Laboratory analysis, Code 5, Data management, Code 9
Celerion Inc. ORG-100029202	Lincoln, United States	Other, Laboratory analysis
CareDx Inc. ORL-000002008	Brisbane, United States	Laboratory analysis

Locations

3 EU/EEA countries · 14 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ended	37	8
Germany	Ended	10	1
Spain	Ended	54	5
Rest of world United States, Canada, Australia	—	91	—

Investigational sites

France

8 sites · Ended

Centre Hospitalier Universitaire De Limoges

Néphrologie et Transplantation, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1

Centre Hospitalier Regional Universitaire De Tours

Nephrology – Hyprtension – Kidney Transplantation, 2 Boulevard Tonnelle, 37000, Tours

Assistance Publique Hopitaux De Paris

Nephrology and Transplant Department, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil

Centre Hospitalier Universitaire De Montpellier

Nephrology, 371 Avenue Du Doyen Gaston Giraud, 34090, Montpellier

Centre Hospitalier Universitaire De Toulouse

Nephrology and Organ Transplantation, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9

Centre Hospitalier Universitaire Grenoble Alpes

Nephrology, Dialysis, Apheresis and Renal Transplantation, Pavillon E, Centre Hospitalier Unvt Grenoble, Grenoble Cedex 09

Pellegrin Hospital

Néphrologie, Transplantation rénale, Dialyse, Place Amelie Raba Leon, 33000, Bordeaux

CHU De Rouen

Nephrology – Renal transplant, 147 Avenue Du Marechal Juin, 76230, Bois-Guillaume

Germany

1 site · Ended

Charite Universitaetsmedizin Berlin KöR

Klinik für Nephrologie und Intensivmedizin, Chariteplatz 1, Mitte, Berlin

Spain

5 sites · Ended

Hospital Germans Trias I Pujol

Nephrology and Trasplant, Carretera Canyet 1a Planta, 08916, Badalona

Hospital Universitari Vall D Hebron

Nephrology and Trasplant, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona

Hospital Del Mar

Nephrology and Trasplant, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona

Hospital Clinic De Barcelona

Nephrology and Trasplant, Calle Villarroel 170, 08036, Barcelona

Bellvitge University Hospital

Nephrology and Trasplant, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end
France	2023-12-06	2025-08-26	2024-02-12	2024-08-27
Germany	2024-02-06	2025-07-02	2024-07-04	2024-07-04
Spain	2023-11-29	2025-08-20	2024-03-14	2024-08-20

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 57 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol Signature Page_2023-503336-41-00_redacted	5.1
Protocol (for publication)	D1_Protocol_2023-503336-41-00_redacted	5.1
Protocol (for publication)	D1_Protocol_Non-Substantial Amendment_2023-503336-41-00_redacted	1
Protocol (for publication)	D1_Protocol_Non-Substantial Protocol Amendment_2023-503336-41-00_redacted	1
Protocol (for publication)	D1_Protocol_Summary of changes_redacted	5.1
Recruitment arrangements (for publication)	K1_DE_Recruitment Procedure	3.0
Recruitment arrangements (for publication)	K1_ES_Recruitment Procedure	3.0
Recruitment arrangements (for publication)	K1_FR_Recruitment Procedure_Bilingual	3.0
Recruitment arrangements (for publication)	K2_DE_Recruitment Material_Multifold_German	1.0
Recruitment arrangements (for publication)	K2_DE_Recruitment Material_Recruitment Poster_German	1.0
Recruitment arrangements (for publication)	K2_DE_Recruitment Material_Study Website_German	1
Recruitment arrangements (for publication)	K2_DE_Recruitment Material_Trifold_German	1.0
Recruitment arrangements (for publication)	K2_ES_Recruitment Material_Multifold_Spanish	1.0
Recruitment arrangements (for publication)	K2_ES_Recruitment Material_Recruitment Poster_Spanish	1.0
Recruitment arrangements (for publication)	K2_ES_Recruitment Material_Study Website_Spanish	1
Recruitment arrangements (for publication)	K2_ES_Recruitment Material_Trifold_Spanish	1.0
Recruitment arrangements (for publication)	K2_FR_Recruitment Material_Recruitment Poster_French	1.0
Recruitment arrangements (for publication)	K2_FR_Recruitment Material_Study Website_French	1
Recruitment arrangements (for publication)	K2_FR_Recruitment Material_Trifold_French	1.0
Subject information and informed consent form (for publication)	L1_DE_SIS-ICF_Main_German_redacted	6.1
Subject information and informed consent form (for publication)	L1_DE_SIS-ICF_PK_German_redacted	2.1
Subject information and informed consent form (for publication)	L1_DE_SIS-ICF_Pregnant Partner_German	1.1
Subject information and informed consent form (for publication)	L1_DE_SIS-ICF_Scout Clinical_German_redacted	2.0
Subject information and informed consent form (for publication)	L1_ES_SIS-ICF_Full PK Panel Addendum_Spanish_redacted	2.1
Subject information and informed consent form (for publication)	L1_ES_SIS-ICF_Main_Spanish_redacted	6.0
Subject information and informed consent form (for publication)	L1_ES_SIS-ICF_Pregnancy_Spanish	1.0
Subject information and informed consent form (for publication)	L1_ES_SIS-ICF_Scout Clinical_Spanish_redacted	2.0
Subject information and informed consent form (for publication)	L1_FR_SIS-ICF_Main_French_redacted	6.0
Subject information and informed consent form (for publication)	L1_FR_SIS-ICF_PK addendum_French_redacted	2.1
Subject information and informed consent form (for publication)	L1_FR_SIS-ICF_Pregnancy_French	1.2
Subject information and informed consent form (for publication)	L1_FR_SIS-ICF_Scout Clinical_French_redacted	2.1
Subject information and informed consent form (for publication)	L2_DE_Other subject material_Reloadable ScoutPass Brochure_German_redacted	1.0
Subject information and informed consent form (for publication)	L2_DE_Other subject material_Scout Clinical Pre-ICF Telephone Data Consent_German	1.0
Subject information and informed consent form (for publication)	L2_DE_Other subject material_SCOUT Email Communication_German_redacted	1.1
Subject information and informed consent form (for publication)	L2_DE_Other subject material_SCOUT study brochure_German	2.0
Subject information and informed consent form (for publication)	L2_ES_Other subject material_Scout Clinical Pre-ICF Telephone Data Consent_Spanish	1.0
Subject information and informed consent form (for publication)	L2_FR_Other subject material_GP letter_French	1.0
Subject information and informed consent form (for publication)	L2_FR_Other subject material_Patient card_French	1.0
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Prograf 0.5mg hard capsules	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Prograf 1mg hard capsules	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Prograf 5mg hard capsules	1
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Prograf 5mg-ml concentrate for solution for infusion	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2023-503336-41-00_French_redacted	5.1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2023-503336-41-00_German_redacted	4.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2023-503336-41-00_redacted	5.1
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2023-503336-41-00_Spanish_redacted	5.1
Synopsis of the protocol (for publication)	D4_DE_Patient Facing Document_KDQOL-36_German	1.1
Synopsis of the protocol (for publication)	D4_ES_Patient Facing Document_MTSOSD-59R (male)_Spanish_redacted	2
Synopsis of the protocol (for publication)	D4_Patient Facing Document_KDQOL-36	1
Synopsis of the protocol (for publication)	D4_Patient Facing Document_KDQOL-36_ES_Spanish	1
Synopsis of the protocol (for publication)	D4_Patient Facing Document_KDQOL-36_FR_French	1
Synopsis of the protocol (for publication)	D4_Patient Facing Document_MTSOSD-59R (female)_DE_German_redacted	1
Synopsis of the protocol (for publication)	D4_Patient Facing Document_MTSOSD-59R (female)_ES_Spanish_redacted	1
Synopsis of the protocol (for publication)	D4_Patient Facing Document_MTSOSD-59R (female)_FR_French_redacted	1
Synopsis of the protocol (for publication)	D4_Patient Facing Document_MTSOSD-59R (male)_DE_German_redacted	1
Synopsis of the protocol (for publication)	D4_Patient Facing Document_MTSOSD-59R (male)_FR_French_redacted	1
Synopsis of the protocol (for publication)	D4_Patient Facing Document_MTSOSD-59R_redacted	1

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-07-11	Spain	Acceptable 2023-10-30	2023-10-30
2	SUBSTANTIAL MODIFICATION	SM-1	2023-11-21	Spain	Acceptable 2024-01-17	2024-01-17
3	SUBSTANTIAL MODIFICATION	SM-2	2024-01-30	Spain	Acceptable 2024-04-18	2024-04-18
4	SUBSTANTIAL MODIFICATION	SM-3	2024-08-16	Spain	Acceptable with conditions 2024-10-15	2024-10-15
5	SUBSTANTIAL MODIFICATION	SM-4	2025-06-12	Spain	Acceptable 2025-07-17	2025-07-17

BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 5

Conditions and MedDRA coding

Study design 3 periods

Eligibility criteria

Inclusion criteria 7

Exclusion criteria 28

Endpoints

Primary endpoints 1

Secondary endpoints 5

Investigational products

Test 2

Comparator 4

Auxiliary 11

Sponsors and contacts

Eledon Pharmaceuticals Inc.

Scientific contact point

Public contact point

Third parties 4

Locations

By country

Investigational sites

Country notifications

Results and documents

Documents 57 files

Application history

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