Clinical trial • Phase IV • Nephrology|Infectious Disease

Mycophenolic acid for Advanced chronic kidney disease|Post-transplant cytomegalovirus infection

Phase IV trial of Mycophenolic acid for Advanced chronic kidney disease|Post-transplant cytomegalovirus infection.

Overview

Trial Therapeutic Area: Nephrology|Infectious Disease
Trial Disease: Advanced chronic kidney disease|Post-transplant cytomegalovirus infection
Trial Stage: Phase IV
Drug Modality: Small molecule|Other antibody

Key dates

Initial CTIS Submission Date: 18-03-2025
First CTIS Authorization Date: 16-06-2025

Trial design

Randomised, open-label, group 1 (experimental): anticipatory therapy as prevention strategy; maintenance immunosuppressive treatment with steroids, tacrolimus and mtor inhibitors. group 2 (control): universal prophylaxis as prevention strategy; maintenance immunosuppressive treatment with steroids, tacrolimus and mycophenolic acid. doses and schedules not specified in the available documents. Phase IV trial across 1 site in Spain.

Randomised: Yes
Open Label: Yes
Comparator: GROUP 1 (Experimental): anticipatory therapy as prevention strategy; maintenance immunosuppressive treatment with steroids, tacrolimus and mTOR inhibitors. GROUP 2 (Control): universal prophylaxis as prevention strategy; maintenance immunosuppressive treatment with steroids, tacrolimus and mycophenolic acid. Doses and schedules not specified in the available documents.
Target Sample Size: 30
Trial Duration For Participant: 183

Eligibility

Recruits 30 No vulnerable populations selected. Only adults (Age more than or equal 18 years). Consent must be provided by the participant: 'Agree to participate in the study by signing the informed consent form.'.

Vulnerable Population: No vulnerable populations selected. Only adults (Age more than or equal 18 years). Consent must be provided by the participant: 'Agree to participate in the study by signing the informed consent form.'

Inclusion criteria

{"criterion_text":"- Age more than or equal 18 years.\n- Positive pretransplant Ig G CMV serology\n- Receive immunosuppressive induction treatment with thymoglobulin (between 1 and 5 doses).\n- - Agree to participate in the study by signing the informed consent form."}

Exclusion criteria

{"criterion_text":"- Patients with negative pretransplant Ig G CMV serology\n- Patients infected with HIV.\n- Patients receiving induction therapy with basiliximab\n- Patients who cannot comply with the follow-up protocol.\n- 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.\n- Patients who for any reason should not be included in the study according to the evaluation of the research team."}

Endpoints

Primary endpoints

{"endpoint_text":"- Primary endpoint: Presence of CMV infection or disease after renal transplantation. This variable will be evaluated at 6 months post-transplantation.","definition_or_measurement_approach":"Evaluated at 6 months post-transplantation."}

Secondary endpoints

{"endpoint_text":"- Recipient demographic variables: gender and age","definition_or_measurement_approach":"Collection of recipient demographic data (gender and age) at baseline."}
{"endpoint_text":"- Recipient variables related to chronic kidney disease (CKD): etiology of CKD, renal replacement therapy (RRT) prior to transplantation, time on RRT in months.","definition_or_measurement_approach":"Collection of CKD-related history including etiology, prior RRT, and duration on RRT (months)."}
{"endpoint_text":"- Donor variables: demographics (age and sex), cause of death, donor type (living, cadaveric and cadaveric donor type), Ig G CMV serology.","definition_or_measurement_approach":"Collection of donor demographic and clinical data including IgG CMV serology."}
{"endpoint_text":"- Peri-transplant variables","definition_or_measurement_approach":"Collection of peri-transplant clinical variables (as specified in protocol)."}
{"endpoint_text":"- CMV-related variables","definition_or_measurement_approach":"Collection of CMV-related clinical and laboratory variables (as specified in protocol)."}

Recruitment

Planned Sample Size: 30
Recruitment Window Months: 19
Consent Approach: Participants must provide informed consent by signing the informed consent form. Document listed: 'Hoja de informacion y consentimiento informado al paciente Estudio TIMTOR_FINAL'. Consent obtained from the participant (adults ≥18 years).

Geography

Total Number Of Sites: 1
Total Number Of Participants: 30

Spain

Earliest CTIS Part Ii Submission Date: 29-04-2025
Latest Decision Or Authorization Date: 20-01-2026
Processing Time Days: 266
Number Of Sites: 1
Number Of Participants: 30

Sites

Site Name: Hospital Universitario La Paz
Department Name: Servicio de 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
Number Of Participants: 30

Sponsor

Primary sponsor

Full Name: Hospital Universitario La Paz
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Spain

Investigational products

Investigational Product Name: Myfortic 180 mg comprimidos gastrorresistentes.
Active Substance: Mycophenolic acid
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: oral
Authorisation Status: Authorised (marketing authorisation present)
Maximum Dose: 1440 mg

Investigational Product Name: Rapamune 0.5 mg coated tablets
Active Substance: Sirolimus
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: oral
Authorisation Status: Authorised (marketing authorisation present)
Maximum Dose: 0.5 mg/kg

Investigational Product Name: TIMOGLOBULINA 5 mg/ml, polvo para solución para perfusión
Active Substance: Rabbit anti-human thymocyte immunoglobulin
Modality: Other antibody
Routes Of Administration: INTRAVENUS USE
Route: intravenous
Authorisation Status: Authorised (marketing authorisation present)
Maximum Dose: 1 mg/kg

Investigational Product Name: prednisona cinfa 5 mg comprimidos EFG
Active Substance: Prednisone
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: oral
Authorisation Status: Authorised (marketing authorisation present)
Maximum Dose: 20 mg

Investigational Product Name: Advagraf 1 mg prolonged-release hard capsules
Active Substance: Tacrolimus
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: oral
Authorisation Status: Authorised (marketing authorisation present)
Maximum Dose: 0.1 mg/kg

Investigational Product Name: Urbason 40 mg polvo y disolvente para solución inyectable
Active Substance: Methylprednisolone sodium succinate
Modality: Small molecule
Routes Of Administration: INTRAVENOUS INJECTION
Route: intravenous
Authorisation Status: Authorised (marketing authorisation present)
Maximum Dose: 100 mg

Investigational Product Name: Valganciclovir Aurovitas 450 mg comprimidos recubiertos con película EFG
Active Substance: Valganciclovir
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: oral
Authorisation Status: Authorised (marketing authorisation present)
Maximum Dose: 900 mg

Combination Treatment: Yes

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