Clinical trial • Phase III • Infectious Disease

VALGANCICLOVIR HYDROCHLORIDE for Cytomegalovirus infection | Kidney transplantation

Phase III trial of VALGANCICLOVIR HYDROCHLORIDE for Cytomegalovirus infection | Kidney transplantation.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Cytomegalovirus infection | Kidney transplantation
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
11-04-2025
First CTIS Authorization Date
26-06-2025

Trial design

Randomised, open-label, control: valganciclovir for 12 months. experimental: cmv-specific cellular immunity (cmi-cmv) assessed with qf-cmv on days +15, +30, +45, +60, and +90; prophylaxis with valganciclovir indicated when ifng concentration < 2.2 iu/ml and prevention protocol discontinued on day +90. Phase III trial in Spain.

Randomised
Yes
Open Label
Yes
Comparator
Control: Valganciclovir for 12 months. Experimental: CMV-specific cellular immunity (CMI-CMV) assessed with QF-CMV on days +15, +30, +45, +60, and +90; prophylaxis with valganciclovir indicated when IFNG concentration < 2.2 IU/mL and prevention protocol discontinued on day +90.
Target Sample Size
170
Trial Duration For Participant
365

Eligibility

Recruits 170 No vulnerable population selected. Inclusion requires Over 18 years of age. A document 'L1_SIS and ICF adults' is listed for subject information and informed consent..

Pregnancy Exclusion
Must have a negative pregnancy test (non-menopausal women)
Vulnerable Population
No vulnerable population selected. Inclusion requires Over 18 years of age. A document 'L1_SIS and ICF adults' is listed for subject information and informed consent.

Inclusion criteria

  • {"criterion_text":"- Over 18 years of age\n- CMV-seropositive kidney transplant recipients\n- Must have a negative pregnancy test (non-menopausal women)"}

Exclusion criteria

  • {"criterion_text":"- HIV-infected patients\n- Patients with multivisceral transplants\n- Those who are not expected to receive universal prophylaxis\n- Receiving induction therapy with anti-thymocyte globulin (ATG)\n- Having HLA excluded from QF-CMV\n- Unable to comply with the follow-up protocol\n- Having CMV replication/disease prior to inclusion"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Efficacy: proportion of patients with CMV disease (incidence) at 6 and 12 months after transplantation.\n- Safety: proportion of patients with different degrees of neutropenia at 6 and 12 months after transplantation.","definition_or_measurement_approach":"Efficacy: incidence of CMV disease assessed at 6 and 12 months post-transplant. Safety: proportion of patients with different degrees of neutropenia assessed at 6 and 12 months post-transplant."}

Secondary endpoints

  • {"endpoint_text":"- 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).\n- Efficacy/safety: CMV disease/neutropenia combination assessed at 6 and 12 months using DOOR (\"Desirability of Outcome Ranking\").","definition_or_measurement_approach":"Secondary 1: number of days on valganciclovir at 6 and 12 months and proportion of AEs with frequency >10% at 6 months. Secondary 2: DOOR ranking combining CMV disease/replication and neutropenia at 6 and 12 months; DOOR estimates probability of better outcome in one group (threshold >50% with 95% CI excluding 50% indicates significance)."}

Recruitment

Planned Sample Size
170
Recruitment Window Months
48
Consent Approach
Informed consent obtained from adult participants. Document listed: 'L1_SIS and ICF adults'. No assent/minor consent procedures specified. Languages of consent not specified.

Geography

Total Number Of Sites
9
Total Number Of Participants
170

Spain

Earliest CTIS Part Ii Submission Date
09-05-2025
Latest Decision Or Authorization Date
26-06-2025
Processing Time Days
48
Number Of Sites
9
Number Of Participants
170

Sites

Site Name
Hospital Universitario Reina Sofia
Department Name
Enfermedades Infecciosas
Principal Investigator Name
Julián Carlos de la Torre Cisneros
Principal Investigator Email
julian.torre.sspa@juntadeandalucia.es
Contact Person Name
Julián Carlos de la Torre Cisneros
Site Name
Clinica Universidad De Navarra
Department Name
Nefrología
Principal Investigator Name
Paloma Leticia Martín Moreno
Principal Investigator Email
plmartin@unav.es
Contact Person Name
Paloma Leticia Martín Moreno
Contact Person Email
plmartin@unav.es
Site Name
Hospital Universitario La Paz
Department Name
Nefrología
Principal Investigator Name
María Ovidia López Oliva
Principal Investigator Email
mlopezo@salud.madrid.org
Contact Person Name
María Ovidia López Oliva
Contact Person Email
mlopezo@salud.madrid.org
Site Name
Hospital Del Mar
Department Name
Nefrología
Principal Investigator Name
María Dolores Redondo Pachón
Principal Investigator Email
mredondopachon@psmar.cat
Contact Person Name
María Dolores Redondo Pachón
Contact Person Email
mredondopachon@psmar.cat
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Nefrología
Principal Investigator Name
Auxiliadora Mazuecos Blanca
Contact Person Name
Auxiliadora Mazuecos Blanca
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Nefrología
Principal Investigator Name
Marta Suñer Poblet
Principal Investigator Email
marta.suner.sspa@juntadeandalucia.es
Contact Person Name
Marta Suñer Poblet
Site Name
Fundacio Puigvert
Department Name
Trasplante Renal
Principal Investigator Name
Carme Facundo Molas
Principal Investigator Email
cfacundo@fundacio-puigvert.es
Contact Person Name
Carme Facundo Molas
Contact Person Email
cfacundo@fundacio-puigvert.es
Site Name
Hospital Universitario 12 De Octubre
Department Name
Goncer
Principal Investigator Name
Isabel Rodríguez
Principal Investigator Email
irgoncer@salud.madrid.org
Contact Person Name
Isabel Rodríguez
Contact Person Email
irgoncer@salud.madrid.org
Site Name
Hospital Universitario De Cruces
Department Name
Enfermedades Infecciosas
Principal Investigator Name
Regino Rodríguez Álvarez
Principal Investigator Email
reginojose.rodriguezalvarez@osakidetza.eus
Contact Person Name
Regino Rodríguez Álvarez

Sponsor

Primary sponsor

Full Name
Fundacion Para La Investigacion Biomedica De Cordoba
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Third parties

  • {"country":"","full_name":"Carlos III Health Institute (ISCIII)","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Valganciclovir Normon 450 mg comprimidos recubiertos con película EFG
Active Substance
VALGANCICLOVIR HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation number 80977, country ES)
Dose Levels
Max daily dose 900 mg
Maximum Dose
900 mg (maxDailyDoseAmount)
Investigational Product Name
Ganciclovir Accord 500 mg polvo para concentrado para solución para perfusión EFG
Active Substance
GANCICLOVIR
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (marketing authorisation number 84368, country ES / MRP PT/H/2000/001)
Dose Levels
Max daily dose 10 mg/kg
Maximum Dose
10 mg/kg (maxDailyDoseAmount)

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