PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

NCT ID: NCT00157300

Last Updated: 2010-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Epoetin beta

Group Type EXPERIMENTAL

Epoetin beta

Intervention Type DRUG

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

Interventions

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Epoetin beta

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

Intervention Type DRUG

Other Intervention Names

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Neorecormon

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Leiden University Medical Center

Principal Investigators

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Ton Rabelink, MD, PhD

Role: STUDY_CHAIR

Leiden University Medical Center

Locations

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Leiden University Medical Center

Leiden, , Netherlands

Site Status

Other transplantation centers

To Be Determined, , Netherlands

Site Status

Countries

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Netherlands

References

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Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.

Reference Type BACKGROUND
PMID: 12435860 (View on PubMed)

Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

Reference Type DERIVED
PMID: 36791280 (View on PubMed)

Other Identifiers

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P05-026

Identifier Type: -

Identifier Source: org_study_id

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