PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

This study has been completed.
Sponsor:
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00157300
First received: September 7, 2005
Last updated: July 30, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Patients Receiving a Kidney From a Non-Heart-Beating Donor
Drug: Epoetin beta
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

Resource links provided by NLM:


Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:
  • incidence of delayed graft function and primary non function after kidney transplantation [ Time Frame: within12 weeks after transplantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • duration of dialysis treatment [ Time Frame: within 12 weeks after transplantation ] [ Designated as safety issue: No ]
  • incidence of acute rejection episodes [ Time Frame: till one year after transplantation ] [ Designated as safety issue: No ]
  • renal function at 3, 6 and 12 months [ Time Frame: 3, 6 and 12 months after transplantation ] [ Designated as safety issue: No ]
  • patient and graft survival [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 92
Study Start Date: July 2005
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoetin beta Drug: Epoetin beta
intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.
Other Name: Neorecormon

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157300

Locations
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Other transplantation centers
To Be Determined, Netherlands
Sponsors and Collaborators
Leiden University Medical Center
Investigators
Study Chair: Ton Rabelink, MD, PhD Leiden University Medical Center
  More Information

Publications:
Responsible Party: Ton Rabelink, MD, PhD, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT00157300     History of Changes
Other Study ID Numbers: P05-026
Study First Received: September 7, 2005
Last Updated: July 30, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:
erythropoietin
kidney transplantation
delayed graft function

Additional relevant MeSH terms:
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014