Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
1
advanced chronic renal insufficiency
The primary objective of the study is to assess the time from hospital arrival to revascularization in patients with acute ischemic stroke treated with mechanical thrombectomy, depending on whether the procedure was performed under sedation with HFNC or under general anesthesia. Monitor CMV-specific cellular immune res…
Key facts
- Sponsor
- Hospital Universitario La Paz
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Trial duration
- 15 Jan 2026 → ongoing
- Decision date (initial)
- 2025-06-16
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The primary objective of the study is to assess the time from hospital arrival to revascularization in patients with acute ischemic stroke treated with mechanical thrombectomy, depending on whether the procedure was performed under sedation with HFNC or under general anesthesia.
Monitor CMV-specific cellular immune response before transplantation and at 15, 30 and 90 days post-transplantation in each of the two treatment groups using Quantiferon-CMV.
Secondary objectives 2
- To compare between the two groups the incidence of delayed initial graft function, acute rejection diagnosed by renal biopsy, renal function and patient and graft survival in the first 6 months post-transplantation.
- To compare between the two groups the presence of surgical (lymphocele requiring intervention) or hematological (neutropenia) complications in the first 6 months post-transplantation.
Conditions and MedDRA coding
advanced chronic renal insufficiency
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 4, exploratory, randomized, open-label, single-center, exploratory clinical trial to evaluate Phase 4, exploratory, randomized, open-label, single-center, exploratory clinical trial to evaluate the effectiveness of CMV prevention strategies comparing anticipatory therapy vs. universal prophylaxis in Ig G CMV-positive kidney transplant recipients treated with thymoglobulin who receive
|
Randomised Controlled | None | GROUP 1: Experimental arm (Group 1): Will receive, as a prevention strategy against CMV, anticipatory therapy, and as maintenance immunosuppressive treatment steroids, tacrolimus and mTOR inhibitors. GROUP 2: Control arm (Group 2): Will receive, as a prevention strategy against CMV, universal prophylaxis, and as maintenance immunosuppressive treatment steroids, tacrolimus and mycophenolic acid. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age more than or equal 18 years.
- Positive pretransplant Ig G CMV serology
- Receive immunosuppressive induction treatment with thymoglobulin (between 1 and 5 doses).
- - Agree to participate in the study by signing the informed consent form.
Exclusion criteria 6
- Patients with negative pretransplant Ig G CMV serology
- Patients infected with HIV.
- Patients receiving induction therapy with basiliximab
- Patients who cannot comply with the follow-up protocol.
- Patients who cannot receive iMTOR as initial maintenance immunosuppressive therapy, such as patients with chronic kidney disease secondary to hepatorenal polycystic kidney disease and those patients who are expected to undergo complex vascular surgery.
- Patients who for any reason should not be included in the study according to the evaluation of the research team.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Primary endpoint: Presence of CMV infection or disease after renal transplantation. This variable will be evaluated at 6 months post-transplantation.
Secondary endpoints 5
- Recipient demographic variables: gender and age
- Recipient variables related to chronic kidney disease (CKD): etiology of CKD, renal replacement therapy (RRT) prior to transplantation, time on RRT in months.
- Donor variables: demographics (age and sex), cause of death, donor type (living, cadaveric and cadaveric donor type), Ig G CMV serology.
- Peri-transplant variables
- CMV-related variables
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
Myfortic 180 mg comprimidos gastrorresistentes.
PRD476850 · Product
- Active substance
- Mycophenolic Acid
- Substance synonyms
- MYCOPHENOLATE
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 1440 mg milligram(s)
- Max total dose
- 259200 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- 66.140
- MA holder
- NOVARTIS FARMACÉUTICA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rapamune 0.5 mg coated tablets
PRD3342090 · Product
- Active substance
- Sirolimus
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0.5 mg/kg milligram(s)/kilogram
- Max total dose
- 45 mg/kg milligram(s)/kilogram
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AH01 — -
- Marketing authorisation
- EU/1/01/171/014
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
TIMOGLOBULINA 5 mg/ml, polvo para solución para perfusión
PRD441290 · Product
- Active substance
- Rabbit Anti-Human Thymocyte Immunoglobulin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 1 mg/kg milligram(s)/kilogram
- Max total dose
- 7 mg/kg milligram(s)/kilogram
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AA04 — ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT)
- Marketing authorisation
- 62650
- MA holder
- SANOFI B.V.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
prednisona cinfa 5 mg comprimidos EFG
PRD2934229 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 1480 mg milligram(s)
- Max treatment duration
- 176 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB — GLUCOCORTICOIDS
- Marketing authorisation
- 75.647
- MA holder
- LABORATORIOS CINFA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Advagraf 1 mg prolonged-release hard capsules
PRD328675 · Product
- Active substance
- Tacrolimus
- Substance synonyms
- TACROLIMUS ANHYDROUS
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0.1 mg/kg milligram(s)/kilogram
- Max total dose
- 17.3 mg/kg milligram(s)/kilogram
- Max treatment duration
- 173 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — -
- Marketing authorisation
- EU/1/07/387/003
- MA holder
- ASTELLAS PHARMA EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Urbason 40 mg polvo y disolvente para solución inyectable
PRD11229768 · Product
- Active substance
- Methylprednisolone Sodium Succinate
- Substance synonyms
- METHYLPREDNISOLONE 21-(SODIUM SUCCINATE)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1830 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- 34023
- MA holder
- FIDIA FARMACEUTICI S.P.A
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Valganciclovir Aurovitas 450 mg comprimidos recubiertos con película EFG
PRD3921167 · Product
- Active substance
- Valganciclovir
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 75600 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AB14 — VALGANCICLOVIR
- Marketing authorisation
- 79.312
- MA holder
- AUROVITAS SPAIN,S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario La Paz
- Sponsor organisation
- Hospital Universitario La Paz
- Address
- Paseo De La Castellana 261
- City
- Madrid
- Postcode
- 28046
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- María Ovidia López Oliva
Public contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- María Ovidia López Oliva
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2026-01-15 | 2026-03-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol TIMTOR_redacted | 1.2 MNS-1 |
| Recruitment arrangements (for publication) | TIMTOR_Recruitment procedure | 1 |
| Subject information and informed consent form (for publication) | Hoja de informacion y consentimiento informado al paciente Estudio TIMTOR_FINAL | 1.1. MNS-1 |
| Summary of Product Characteristics (SmPC) (for publication) | Advagraf Ficha tecnica version espanol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Myfortic Ficha tecnica version espanol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Prednisona Ficha tecnica version espanol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Rapamune Ficha tecnica version espanol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Timoglobulina Ficha tecnica version espanol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Urbason Ficha tecnica version espanol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Valganciclovir Ficha tecnica version espanol | 1 |
| Synopsis of the protocol (for publication) | Resumen espanol Estudio TIMTOR | 1.1. MNS-1 |
| Synopsis of the protocol (for publication) | Resumen ingles Estudio TIMTOR | 1.1 MNS-1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-18 | Spain | Acceptable 2025-06-10
|
2025-06-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-20 | Spain | Acceptable 2025-06-10
|
2026-01-20 |