kidney preservation by Custodiol-N or Custodiol solution before living related kidney transplantation MedDRA version: 17.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Custodiol-N
Product Name: Custodiol-N
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
CAS Number: 71-00-1
Sponsors
Essen University Hospital, University of Essen, Klinik für Allgemein-, Viszeral- und Transplantationschirugie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.all indications for kidney transplantation as defined by local transplant law (TPG, Abs. 4, § 10) 2.living donors should fulfil the criteria for living organ donation in accord-ance to local transplant law (TPG, Abs. 3, § 8) 3.recipients awaiting their first transplant 4.recipients = 18 years 5.recipient’s signed informed consent before the transplantation of data use and protection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. any contraindication for performance of a kidney transplantation as defined by local transplant law (TPG, Abs. 4, § 10) 2. donors or recipients participating in another study involving compound/interventions aimed at the reduction of preservation and/or ischemia/reperfusion injury 3. deceased donor kidney transplantation 4. pregnant or lactating recipient patients 5. female recipients of child-bearing potential who are not using a highly effective contraception method with a pearl-index 85% 11. ABO incompatible kidney transplantation 12. Known hypersensitivity/anaphylaxis against iron chelators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The study is designed as a non-inferiority trial where renal function (GFR) at follow-up is the primary endpoint. A GFR of 60 +/- 15 ml/min was expected at fol-low-up, and 10 ml/min was considered as a clinically relevant difference. ;Timepoint(s) of evaluation of this end point: Three months after transplantation.; Main Objective: The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in kidney transplantation. Non-inferiority of Custodiol-N vs. Custodiol perfusion in relation to renal function reflected through the GFR calculated with CKD EPI GFR Equation at 3 months after transplantation. ; Secondary Objective: 1. Incidence of primary non-function (PNF) in the study period 2. Incidence of delayed graft function (DGF) in the study period 3. GFR calculated with Cystatin C GFR Equation at day 7 and 1 and 3 months after transplantation 4. GFR calculated with CKD EPI GFR Equation at day 7 and 1 months after transplantation 5. Serum creatinine and serum urea on day 1, 3, 7 and 1 and 3 months after transplantation 6. Graft survival during the study period 7. Patient survival at during the study period 8. Occurrence of minor and major complications (classification in accordance to Clavien-Dindo) in the study period 9. Biopsy-proven rejections in the study period 10. Dialysis requirement in the study period 11. Cortical tissue perfusion (measured by O2c) 30 minutes after reperfusion | — |
Countries
Germany
Contacts
Public ContactInvestigator
Essen University Hospital, University of Essen, Klinik für Allgemein-, Viszeral- und Transplantationschirugie
Outcome results
None listed