PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

L

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

92 participants in 1 patient group

Epoetin beta
Experimental group
Treatment:
Drug: Epoetin beta

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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