A study to investigate the efficacy and safety of frexalimab versus tacrolimus in adults undergoing kidney transplantation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

2 Apr 2026 → ongoing

Decision date (initial)

2026-03-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2025-521521-33-00

WHO UTN

U1111-1314-5393

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacogenetic, Safety, Efficacy

To demonstrate noninferiority of frexalimab as compared to tacrolimus in preventing kidney graft rejection

Secondary objectives 10

1. To assess the effect of frexalimab compared to tacrolimus on kidney graft function
2. To assess the effect of frexalimab compared to tacrolimus on participant and graft survival
3. To assess the effect of frexalimab in preventing kidney graft rejection and chronic allograft nephropathy
4. To assess the effect of frexalimab on anti-graft response
5. To assess the safety and tolerability of frexalimab
6. To assess the safety of the investigational injector device (OBDS)
7. To assess the tolerability of frexalimab as assessed by a treatment-specific PRO
8. To characterize the pharmacokinetics of frexalimab SC (with OBDS) and IV administration in participants with kidney transplantation
9. To evaluate the immunogenicity of frexalimab in participants with kidney transplantation
10. To evaluate the occurrence and control of comorbidities with frexalimab

Conditions and MedDRA coding

Kidney transplant rejection

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysys plan and dataset specifications.Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria , eligible studies and process for requesting can be found at: https://vivli.org

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
2. Participants with low to moderate immunological risk.

Exclusion criteria 7

1. Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death.
2. Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening.
3. Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation.
4. Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy
5. Evidence of active or latent TB, HIV, HBV or HCV infection.
6. Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.
7. Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation

Secondary endpoints 26

1. eGFR at 1 year post kidney transplantation
2. eGFR at 6 months, 2 years, 3 years, 4 years, and 5 years post kidney transplantation
3. Change of eGFR from Month 3 over time up to 5 years post kidney transplantation
4. Participant status of eGFR >60 mL/min/1.73 m2 at 1, 2, 3, and 5 years post kidney transplantation
5. Participant status of eGFR <60 mL/min/1.73 m² at Month 12 or with a >10 mL/min/1.73 m² decrease in eGFR from Month 3 to 12
6. Proteinuria at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation
7. iBox score at 1 year post kidney transplantation
8. Composite of participant and graft survival at 5 years post kidney transplantation
9. Composite of participant and graft survival over time and at 6 months, 1 year, 2 years, 3 years, and 4 years post kidney transplantation
10. Death-censored graft survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of graft loss)
11. Participant survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of death)
12. Incidence of BPAR (yearly and cumulative) up to 5 years post kidney transplantation
13. Time to first BPAR
14. Incidence of graft rejection at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation
15. Incidence of rejection episodes with clinical resolution up to 5 years post kidney transplantation
16. Composite efficacy failure rate (BPAR, graft loss, and death) by 6 months post kidney transplantation
17. Incidence of de novo donor-specific antibodies at 1 year post kidney transplantation
18. Incidence of de novo donor-specific antibodies at 5 years post kidney transplantation
19. Participants with AEs, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and PCSAs in laboratory tests, ECG, and vital signs during the study period
20. Participants with medical device AEs, ADEs, medical device SAEs, SADEs, and device deficiencies during the study period
21. Side effects of immunosuppressive therapy evaluated by MTSOSD-59R score at Months 1, 2, 3, 4, 5, 6 and then every 6 months until the end of the study
22. Frexalimab plasma concentration over time
23. Incidence, titer, and persistence of ADA
24. Incidence of new-onset diabetes post kidney transplantation
25. Incidence and prevalence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure
26. Incidence and prevalence of dyslipidemia, lipid-lowering regimen, and measures of dyslipidemia, including serum TG and total, non-HDL, LDL, and HDL cholesterol

Investigational products

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

Test 1

Comparator 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

13 Quai Jules Guesde

City

Vitry Sur Seine

Postcode

94400

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 10

Locations

12 EU/EEA countries · 46 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 163 files

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

Application history

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