PREDNISONE for Kidney transplantation

Inclusion criteria

• {"criterion_text":"- patients of 60 years or older receiving a deceased or living kidney transplant and at time of transplantation no donor-specific anti-HLA antibodies.\n- Re-transplantations are allowed when meeting the before mentioned criteria.\n- Patients have to give written informed consent to participate in the study."}

Exclusion criteria

• {"criterion_text":"- HLA-identical living-related transplantation\n- the presence of an immunological-mediated disease requiring immunosuppression\n- ABO-blood group incompatibility or positive CDC-test with the donor as performed at the HLA lab of the participating UMC\n- presence of donor-specific anti-HLA antibodies as defined by the Luminex assay (presence defined as MFI above background level)\n- combined liver/kidney or pancreas/kidney transplantation or previous organ transplantation other than kidney\n- participation in another clinical trial interfering with immune suppressive medication or risk of infection\n- not able to stop prednisone because of long-term use\n- eGFR <25 ml/min at month 3\n- within the first 3 months after transplantation: any biopsy-proven rejection requiring T cell depletion or biopsy-proven antibody-mediated rejection\n- not able to provided written informed consent"}

Primary endpoints

• {"endpoint_text":"- death by infectious disease","definition_or_measurement_approach":""}
• {"endpoint_text":"- infectious burden defined as the number of infections requiring hospitalization and/or proven viral infections including cytomegalovirus and BK-virus replication within a follow-up of 3 years.","definition_or_measurement_approach":"Infectious burden defined as the number of infections requiring hospitalization and/or proven viral infections including cytomegalovirus and BK-virus replication within a follow-up of 3 years."}

Secondary endpoints

• {"endpoint_text":"- quality of life","definition_or_measurement_approach":""}
• {"endpoint_text":"- biopsy-proven rejection from time of randomization to end of follow-up at 3 years post-transplantation.","definition_or_measurement_approach":"Biopsy-proven rejection measured from randomization to 3 years post-transplantation."}
• {"endpoint_text":"- Assessment of de novo alloantibody formation as detected by a Luminex-based assay (6 months, 1,2 and 3 years after transplantation)","definition_or_measurement_approach":"Detection of de novo alloantibody formation using a Luminex-based assay at 6 months, 1, 2 and 3 years after transplantation."}
• {"endpoint_text":"- Assessment of the circulating alloreactive T cells in time (before, 1, 2 and 3 years after transplantation)","definition_or_measurement_approach":"Assessment of circulating alloreactive T cells at baseline (before) and at 1, 2 and 3 years after transplantation."}
• {"endpoint_text":"- Graft function measured by eGFR and 24-hr urine collection","definition_or_measurement_approach":"Graft function assessed using eGFR and 24-hour urine collection."}
• {"endpoint_text":"- Patient and graft survival","definition_or_measurement_approach":"Patient and graft survival assessed during follow-up (up to 3 years)."}

Netherlands

Earliest CTIS Part Ii Submission Date

27-03-2025

Latest Decision Or Authorization Date

06-06-2025

Processing Time Days

71

Number Of Sites

3

Number Of Participants

304

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Erasmus Medical Center","duties_or_roles":"","organisation_type":""}
• {"country":"","full_name":"Chiesi Pharmaceuticals","duties_or_roles":"","organisation_type":""}
• {"country":"","full_name":"Nierstichting Nederland","duties_or_roles":"","organisation_type":""}