PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

July 30, 2010 updated by: Leiden University Medical Center

Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation.

The investigators postulate that erythropoietin reduces the risk of delayed graft function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, double blind, placebo controlled, prospective trial in patients, receiving a kidney transplantation. Patients will be randomized to receive either Epoetin Beta (Neorecormon; Roche) or placebo.

The primary endpoint will be delayed graft function. The anticipated duration of this trial is 2 year and the target sample size is 60 patients per arm.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leiden, Netherlands, 2300 RC
        • Leiden University Medical Center
      • To Be Determined, Netherlands
        • Other transplantation centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients
  • Receiving a kidney from a non-heart-beating donor category 3

Exclusion Criteria:

  • Donor related factors: a prolonged warm ischaemic time (> 45 min); a cold ischaemic time of > 24 hours; serum creatinin of > 150 umol/l

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epoetin beta
Drug: Epoetin beta
intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
Other Names:
  • Neorecormon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence of delayed graft function and primary non function after kidney transplantation
Time Frame: within12 weeks after transplantation
within12 weeks after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
duration of dialysis treatment
Time Frame: within 12 weeks after transplantation
within 12 weeks after transplantation
incidence of acute rejection episodes
Time Frame: till one year after transplantation
till one year after transplantation
renal function at 3, 6 and 12 months
Time Frame: 3, 6 and 12 months after transplantation
3, 6 and 12 months after transplantation
patient and graft survival
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Investigators

  • Study Chair: Ton Rabelink, MD, PhD, Leiden University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

August 2, 2010

Last Update Submitted That Met QC Criteria

July 30, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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