PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

Leiden University Medical Center (LUMC)

Status and phase: Completed; Phase 4

Conditions: Patients Receiving a Kidney From a Non-Heart-Beating Donor

Treatments: Drug: Epoetin beta

Study type: Interventional

Funder types: Other

Identifiers

NCT00157300

P05-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 1 patient group

Epoetin beta

Experimental group

Treatment:

Drug: Epoetin beta