Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
170
Countries
1
Sites
9
Low-risk renal transplant patients
Compare the efficacy and safety of immune-guided prophylaxis versus preemptive therapy in kidney transplant recipients.
Key facts
- Sponsor
- Fundacion Para La Investigacion Biomedica De Cordoba
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 19 Dec 2025 → ongoing
- Decision date (initial)
- 2025-06-26
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Carlos III Health Institute (ISCIII)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
Compare the efficacy and safety of immune-guided prophylaxis versus preemptive therapy in kidney transplant recipients.
Secondary objectives 5
- Identify a subgroup of patients in whom viral monitoring can be avoided.
- Identify CMI-seropositive patients with non-protective CMI-CMV to ensure proper prevention.
- Compare valganciclovir consumption between both groups and analyze the development of neutropenia.
- Identify antiviral resistance through mutation studies in the involved genes (UL97, UL54), Sanger sequencing, and next-generation sequencing (NGS) in patients with refractory replication.
- Study the differences in efficacy and safety of immune-guided prophylaxis based on the recipient's sex.
Conditions and MedDRA coding
Low-risk renal transplant patients
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10009703 | CMV infection | 10021881 |
| 21.0 | PT | 10038533 | Renal transplant | 100000004865 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Control and experimental group
|
Randomised Controlled | None | Control: Advanced Therapy: 12 months Valganciclovir Experimental group: CMV-specific cellular immunity (CMI-CMV) will be assessed using the QF-CMV test on days +15, +30, +45, +60, and +90 after transplantation. Prophylaxis with valganciclovir will be indicated when the patient has an IFNG concentration < 2.2 IU/mL. The prevention protocol will be discontinued on day +90. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Over 18 years of age
- CMV-seropositive kidney transplant recipients
- Must have a negative pregnancy test (non-menopausal women)
Exclusion criteria 7
- HIV-infected patients
- Patients with multivisceral transplants
- Those who are not expected to receive universal prophylaxis
- Receiving induction therapy with anti-thymocyte globulin (ATG)
- Having HLA excluded from QF-CMV
- Unable to comply with the follow-up protocol
- Having CMV replication/disease prior to inclusion
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Efficacy: proportion of patients with CMV disease (incidence) at 6 and 12 months after transplantation.
- Safety: proportion of patients with different degrees of neutropenia at 6 and 12 months after transplantation.
Secondary endpoints 2
- Safety: number of days with valganciclovir (at 6 and 12 months post-transplant) and proportion of patients with adverse events occurring at a frequency >10% (at 6 months post-transplant).
- Efficacy/safety: CMV disease/neutropenia combination assessed at 6 and 12 months using DOOR ("Desirability of Outcome Ranking"). The best outcome is no CMV disease/replication without neutropenia (<1500 mm³), while the worst is CMV disease/replication with neutropenia. DOOR ranks patient outcomes and estimates the probability of a better result in one group. A >50% probability, with 95% confidence intervals excluding 50%, indicates a significantly better outcome.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Ganciclovir Accord 500 mg polvo para concentrado para solución para perfusión EFG
PRD11857387 · Product
- Active substance
- Ganciclovir
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 10 mg/kg milligram(s)/kilogram
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AB06 — GANCICLOVIR
- Marketing authorisation
- 84368
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Valganciclovir Normon 450 mg comprimidos recubiertos con película EFG
PRD4165171 · Product
- Active substance
- Valganciclovir Hydrochloride
- Substance synonyms
- RS-79070-194 , VALGANCICLOVIR HCL
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- J05AB14 — VALGANCICLOVIR
- Marketing authorisation
- 80977
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Biomedica De Cordoba
- Sponsor organisation
- Fundacion Para La Investigacion Biomedica De Cordoba
- Address
- Avenida Menendez Pidal S/n
- City
- Cordoba
- Postcode
- 14004
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomedica De Cordoba
- Contact name
- Dr. Julian Carlos de la Torre Cisneros
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomedica De Cordoba
- Contact name
- Lourdes Alcaide
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 170 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Del Mar
Nefrología, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario 12 De Octubre
Goncer, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario La Paz
Nefrología, Paseo De La Castellana 261, 28046, Madrid
Fundacio Puigvert
Trasplante Renal, Calle De Cartagena 340-350, 08025, Barcelona
Clinica Universidad De Navarra
Nefrología, Pio XII Etorbidea 36, 31008, Pamplona
University Hospital Virgen Del Rocio S.L.
Nefrología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Reina Sofia
Enfermedades Infecciosas, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Puerta Del Mar
Nefrología, Avenida De Ana De Viya 21, 11009, Cadiz
Hospital Universitario De Cruces
Enfermedades Infecciosas, Cruces Plaza S/n, 48903, Barakaldo
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 | 2025-12-19 | 2026-02-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocolo V1 _2025-520742-29-00_redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recuitment arrangements_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC_Ganciclovir | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPc_Valganciclovir | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis V1_2025-520742-29-00 | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-11 | Spain | Acceptable 2025-06-04
|
2025-06-26 |