PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation - Full Text View

Sponsored by:	Leiden University Medical Center
Information provided by:	Leiden University Medical Center
ClinicalTrials.gov Identifier:	NCT00157300

Purpose

Randomized, double blind, placebo controlled, prospective trial investigating the effect of erythropoietin in renal transplantation.

We 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 IV

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Epoetin alfa Erythropoietin Epoetin beta

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

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

Secondary Outcome Measures:

duration of dialysis treatment
incidence of acute rejection episodes
renal function at 3, 6 and 12 months
patient and graft survival

Estimated Enrollment:	120
Study Start Date:	July 2005
Estimated Study Completion Date:	September 2008

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

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

Contacts

Contact: Zeynep Aydin, MD

0031715262148

Z.Aydin@lumc.nl

Locations

Netherlands
Leiden University Medical Center	Recruiting
Leiden, Netherlands, 2300 RC
Contact: Zeynep Aydin, MD 0031715269111 Z.Aydin@lumc.nl
Contact: Johan W de Fijter, MD, PhD 0031715269111 J.W.de_Fijter@lumc.nl
Principal Investigator: Zeynep Aydin, MD
Other transplantation centers	Not yet recruiting
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:

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.

Study ID Numbers:	P05-026
Study First Received:	September 7, 2005
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00157300
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

Study placed in the following topic categories:

Epoetin Alfa
Delayed Graft Function

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009