PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

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

Official title:

PROTECT: Prospective Trial on Erythropoietin in Clinical Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157300
• Other study ID #: P05-026
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: July 30, 2010
• Start date: July 2005
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• Epoetin beta
intravenous, 33000 IU, 3 consecutive days, starting 3-4 hours before transplantation. Total dose 100.000 IU.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Other transplantation centers	To Be Determined

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of delayed graft function and primary non function after kidney transplantation		within12 weeks after transplantation	No
Secondary	duration of dialysis treatment		within 12 weeks after transplantation	No
Secondary	incidence of acute rejection episodes		till one year after transplantation	No
Secondary	renal function at 3, 6 and 12 months		3, 6 and 12 months after transplantation	No
Secondary	patient and graft survival		one year	No