ALKALINE PHOSPHATASE, BOVINE for End-stage kidney disease | Kidney transplantation (donation after circulatory death)

Inclusion criteria

• {"criterion_text":"- Patients recipients of a donor awaiting cardiac death on the intensive care (definition of a donor cardiac death type III according to the ‘Maastricht classification’)"}
• {"criterion_text":"- Age >18"}
• {"criterion_text":"- Can give written informed consent"}

Exclusion criteria

• {"criterion_text":"- Strict vegetarians"}
• {"criterion_text":"- Vegans"}
• {"criterion_text":"- History of allergy to bovine proteins"}

Primary endpoints

• {"endpoint_text":"- Difference between treatment and placebo group in delayed graft function (DGF) duration (in days) as measured on day 28. DGF is defined as need for dialysis within 7 days after transplantation, excluding single sessions for hyperkalemia. No need for dialysis will be registered as 0 days.","definition_or_measurement_approach":"DGF defined as need for dialysis within 7 days post-transplant (excluding single sessions for hyperkalemia). Duration measured in days at day 28; no dialysis recorded as 0 days."}

Secondary endpoints

• {"endpoint_text":"- Mean duration of hospitalization after kidney transplantation","definition_or_measurement_approach":"Mean duration (days) of hospital stay after transplantation."}
• {"endpoint_text":"- Incidence of persistent dialysis DGF (> 14 days)","definition_or_measurement_approach":"Proportion of patients requiring dialysis >14 days post-transplant."}
• {"endpoint_text":"- Incidence of functional and dialysis DGF","definition_or_measurement_approach":"Incidence rates of functional DGF and dialysis-dependent DGF as defined in protocol."}
• {"endpoint_text":"- Duration of DGF using functional and dialysis definition and a combination of the two","definition_or_measurement_approach":"Duration of DGF measured according to functional and dialysis definitions and combined metric."}
• {"endpoint_text":"- Dall of serum creatinine in the first week after transplantation","definition_or_measurement_approach":"Change (fall) in serum creatinine during first week post-transplant (measurements in mg/dL or µmol/L as per protocol)."}
• {"endpoint_text":"- Kidney perfusion contrast renography at day 6","definition_or_measurement_approach":"Assessment of kidney perfusion by contrast renography performed on day 6 post-transplant."}
• {"endpoint_text":"- Creatinine clearance at 3 months and 1 year after transplantation","definition_or_measurement_approach":"Measured creatinine clearance at 3 months and 1 year post-transplant."}
• {"endpoint_text":"- Proteinuria at 3 months and 1 year after transplantation","definition_or_measurement_approach":"Proteinuria assessment at 3 months and 1 year post-transplant."}
• {"endpoint_text":"- Estimated renal glomerular filtration rate (eGFR) calculated with MDRD and the CKD-epi formula at 3 months and 1 year after transplantation","definition_or_measurement_approach":"eGFR calculated using MDRD and CKD-EPI formulas at 3 months and 1 year."}
• {"endpoint_text":"- Primary non-function (defined as dialysis dependency or creatinine clearance <20ml/min at 3 months).","definition_or_measurement_approach":"Primary non-function defined as dialysis dependence or creatinine clearance <20 ml/min at 3 months."}
• {"endpoint_text":"- Incidence of biopsy proven rejection within one year follow-up period.","definition_or_measurement_approach":"Incidence of biopsy-proven rejection events within 1 year of transplant."}
• {"endpoint_text":"- All-cause mortality at day 28 and 90 and 1 year.","definition_or_measurement_approach":"All-cause mortality assessed at day 28, day 90 and at 1 year post-transplant."}

Netherlands

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

07-10-2025

Processing Time Days

342

Number Of Sites

2

Number Of Participants

1

Primary sponsor

Full Name

Stichting Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands