Comparison of Custodiol-N solution with Custodiol solution in kidney transplantatio

Phase 1

• Conditions: 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; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2013-005503-13-DE
• Lead Sponsor: Essen University Hospital, University of Essen, Klinik für Allgemein-, Viszeral- und Transplantationschirugie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-12
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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 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

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 clinical trial of medicinal product
• Study Design: Not specified