Organ perfusion with Custodiol-N compared with Custodiol solution in living donor kidney transplantatio

Completed

Conditions: Kidney failureLiving donor kidney transplantation
Urological and Genital Diseases

Registration Number: ISRCTN44414069

Lead Sponsor: Klinik für Allgemein-, Viszeral- und Transplantationschirurgie/ Universitätsklinikum Essen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 72

Inclusion Criteria

1. All indications for kidney transplantation as defined by local transplant law (TPG, Abs. 4, § 10)
2. Living donors should fulfill the criteria for living organ donation in accordance to local transplant law (TPG, Abs. 3, § 8)
3. Recipients awaiting their first transplant
4. Recipients = 18 years
5. The recipient’s signed informed consent of data use and protection before randomization

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 <1
6. Multiorgan transplantation
7. Double kidney transplantation
8. Perfusion of the kidney by machine perfusion
9. Repeated kidney transplantation
10. Panel reactive antibodies > 85%
11.ABO incompatible kidney transplantation
12. Known hypersensitivity/anaphylaxis against iron chelators

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-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 Outcome Measures

Name	Time	Method
1. Incidence of primary non-function (PNF) in the study period<br>2. Incidence of delayed graft function (DGF) in the study period<br>3. GFR calculated with Cystatin C GFR Equation at day 7 and 1 and 3 months after transplantation<br>4. GFR calculated with CKD EPI GFR Equation at day 7 and 1 months after transplantation<br>5. Serum creatinine and serum urea on day 1, 3, 7 and 1 and 3 months after transplantation<br>6. Graft survival during the study period<br>7. Patient survival during the study period <br>8. Occurrence of minor and major complications (classification in accordance to Clavien-Dindo) in the study period<br>9. Biopsy-proven rejections in the study period<br>10. Dialysis requirement in the study period<br>11. Cortical tissue perfusion (measured by O2c) 30 minutes after reperfusion