Donor Dopamine and Initial Graft Function

NCT00115115 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 487

Last updated 2009-04-23

No results posted yet for this study

Summary

Donor pre-treatment with dopamine reduces injury to the kidney graft with consequences on the clinical performance immediately after transplantation: Donor dopamine reduces the requirement of dialysis post transplant, and results in renal function improvements.

The purpose of the study is to investigate the potentially therapeutic impact of donor preconditioning with low dose dopamine in human renal transplant recipients from a brain dead donor.

Conditions

  • Kidney Transplantation
  • ESRD

Interventions

DRUG

Dopamine infusion to brain dead organ donors

Dopamine infusion administered at a dosage of 4µg/kg/min starting after brain death has been proven until to surgical procurement of the kidneys

Sponsors & Collaborators

  • Eurotransplant International Foundation, Leiden, The Netherlands

    collaborator OTHER
  • Regional Organ Procurement Organization (DSO), Baden-Wuerttemberg, Germany

    collaborator OTHER
  • Regional Organ Procurement Organization (DSO), Bavaria, Germany

    collaborator OTHER
  • Novartis

    collaborator INDUSTRY
  • Universitätsmedizin Mannheim

    lead OTHER

Principal Investigators

  • Peter Schnuelle, MD · Universitätsmedizin Mannheim

  • Fokko J van der Woude, MD, PhD · Universitätsmedizin Mannheim

  • Werner Lauchart, MD · Organ procurement organization (DSO) of Baden-Wuerttemberg

  • Detlef Boesebeck, MD · Organ procurement organization (DSO) of Bavaria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2007-12-31
Completion
2009-03-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00115115 on ClinicalTrials.gov