Mycophenolate sodium (mycophenolic acid) for End-stage renal disease

Inclusion criteria

• {"criterion_text":"- Subjects must be able to understand and provide written informed consent.\n- Patients ≥ 70 years who receive their first (live or deceased donor) ABO-compatible renal transplant.\n- Patients with a pre-transplant cPRA ≤ 50%.\n- Recipient of a kidney with a cold ischemia time < 30 hours.\n- Male participants will be required to use a dual barrier method (e.g., condom plus spermicide)."}

Exclusion criteria

• {"criterion_text":"- Patients who received another simultaneous solid organ transplant (liver, lung, heart, or pancreas).\n- Patients with pre-existing (historical or at the time of transplantation DSA - MFI>1000).\n- Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).\n- Subject who is anti-HIV-positive, HBsAg-positive, or anti-HCV positive.\n- Subject requiring systemic anticoagulation that cannot be temporarily interrupted and which would preclude renal biopsy.\n- Subjects unable to take oral medication at the time of randomization.\n- Subjects with any medical condition at the time of randomization that, according to the investigator criteria, contraindicates the administration of the trial immunosuppression scheme.\n- Any known hypersensitivity or intolerance to study drugs or their active ingredients."}

Primary endpoints

• {"endpoint_text":"- Composite outcome of patient survival with functioning graft at 12 months in both treatment arms.","definition_or_measurement_approach":"Composite outcome measured at 12 months assessing patient survival with functioning graft (patient and graft survival during the 1st year after transplantation)."}

Secondary endpoints

• {"endpoint_text":"- Mortality for any reason in both treatment arms.","definition_or_measurement_approach":"All-cause mortality recorded in both arms during follow-up (1st year)."}
• {"endpoint_text":"- Rate of primary non-function graft in both treatment arms.","definition_or_measurement_approach":"Incidence of primary non-function graft assessed in both arms."}
• {"endpoint_text":"- Incidence of surgical complications in both treatment arms.","definition_or_measurement_approach":"Recording of surgical complications occurring within the 1st year post-transplant in both arms."}
• {"endpoint_text":"- Days of hospitalization for any reason in both treatment arms.","definition_or_measurement_approach":"Total days of hospitalization for any cause during follow-up in both arms."}
• {"endpoint_text":"- Number of readmissions and cause in both treatment arms.","definition_or_measurement_approach":"Count of hospital readmissions and their causes within the follow-up period in both arms."}
• {"endpoint_text":"- Incidence of CMV and BK viremia in both treatment arms.","definition_or_measurement_approach":"Incidence of CMV and BK viremia measured by appropriate virological testing during the 1st year."}
• {"endpoint_text":"- Incidence of CMV invasive disease and BK nephropathy in both treatment arms.","definition_or_measurement_approach":"Clinically defined CMV invasive disease and biopsy-proven BK nephropathy incidence in both arms."}
• {"endpoint_text":"- Incidence of clinical graft acute rejection through indication biopsy at any time in both treatment arms.","definition_or_measurement_approach":"Incidence of clinical acute rejection confirmed by indication biopsy at any time during follow-up."}
• {"endpoint_text":"- Incidence of subclinical graft rejection at 12 months through protocol biopsy in both treatment arms.","definition_or_measurement_approach":"Incidence of subclinical rejection assessed by protocol biopsy at 12 months."}
• {"endpoint_text":"- PREM and PROMS at randomization and at 12 months in both treatment arms.","definition_or_measurement_approach":"Patient-reported experience measures (PREM) and patient-reported outcome measures (PROMs) collected at baseline and 12 months."}
• {"endpoint_text":"- Frailty (Fried and FRAIL scale) before transplant and at 12 months in both treatment arms.","definition_or_measurement_approach":"Frailty assessed using Fried and FRAIL scales at baseline and 12 months."}
• {"endpoint_text":"- Death-censored graft survival in both treatment arms.","definition_or_measurement_approach":"Graft survival censored for patient death, evaluated in both arms."}
• {"endpoint_text":"- Graft function (eGFR and proteinuria) at 12 months in both treatment arms.","definition_or_measurement_approach":"Estimated glomerular filtration rate (eGFR) and proteinuria measured at 12 months."}
• {"endpoint_text":"- Donor-specific antibodies (DSA) at 12 months in both treatment arms.","definition_or_measurement_approach":"DSA presence/levels measured at 12 months."}
• {"endpoint_text":"- Estimated 5-y death-censored graft survival through the iBox prognostication system at 12 months in both treatment arms.","definition_or_measurement_approach":"iBox prognostication system used at 12 months to estimate 5-year death-censored graft survival."}
• {"endpoint_text":"- Rate of dropout from the initial immunosuppression scheme assigned in both treatment arms.","definition_or_measurement_approach":"Proportion of patients discontinuing the initially assigned immunosuppression regimen during follow-up."}
• {"endpoint_text":"- Exploratory: Torquetenovirus RT-PCR at 1, 3, 6 and 12 months in both treatment arms.","definition_or_measurement_approach":"TTV RT-PCR viral load measured at months 1, 3, 6 and 12."}
• {"endpoint_text":"- Exploratory: Count of CD4/CD8 lymphocyte subpopulations, C3 levels, and IgG levels at 1, 3, and 12 months in both treatment arms.","definition_or_measurement_approach":"Immunological markers (CD4/CD8 counts, C3, IgG) measured at months 1, 3 and 12."}

Spain

Earliest CTIS Part Ii Submission Date

17-06-2025

Latest Decision Or Authorization Date

19-08-2025

Processing Time Days

63

Number Of Sites

13

Number Of Participants

270

Primary sponsor

Full Name

Consorci Mar Parc De Salut De Barcelona

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain