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NCT Number: NCT00157300

PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

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.

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Key information

Conditions

Patients Receiving a Kidney From a Non-Heart-Beating Donor Delayed Graft Function Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Leiden University Medical Center, Leiden, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epoetin beta

Drug

intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.

Other names: Neorecormon

Primary outcomes

  1. incidence of delayed graft function and primary non function after kidney transplantation

    Time frame: within12 weeks after transplantation

Secondary outcomes

  1. duration of dialysis treatment

    Time frame: within 12 weeks after transplantation

  2. incidence of acute rejection episodes

    Time frame: till one year after transplantation

  3. renal function at 3, 6 and 12 months

    Time frame: 3, 6 and 12 months after transplantation

  4. patient and graft survival

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 12, 2005
Registry last updated
Aug 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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