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NCT00425126 Clinical Trial

Effect of Procrit (Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation

Delayed Graft Function Clinical Trial

Official title:
Effect of Procrit(Epoetin Alfa) on Preventing Delayed Graft Function After Deceased Donor Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00425126
Other study ID # RC-4044
Secondary ID
Status Completed
Phase Phase 4
First received January 18, 2007
Last updated May 25, 2010
Start date February 2007
Est. completion date February 2010

Study information
Verified date May 2010
Source West Penn Allegheny Health System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Delayed graft function (DGF) is a major complication following deceased donor renal transplantation. The surgical procedure of harvesting a kidney from a cadaveric donor and implanting the kidney into the recipient inevitably causes some amount of injury. While not always clinically significant, anywhere from 10-50% of transplant patients may develop DGF. Ongoing research in animal models has demonstrated benefit with administration of erythropoietin. The investigators propose to study the effect of Procrit(Epoetin Alfa) on delayed graft function in subjects undergoing kidney transplantation.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients presenting for kidney transplantation

- Age > 18

- Deceased donor kidney transplant

Exclusion Criteria:

- History of thrombosis or hypercoagulable state

- Receiving Coumadin or Heparin

- Hemoglobin >=14 g/dl

- Uncontrolled hypertension

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Epoetin Alfa

Locations
Country Name City State
United States Allegheny General Hospital Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decrease in Delayed Graft Function
See also
  Status Clinical Trial Phase
Withdrawn NCT02312115 - Delayed Renal Allograft Function and Furosemide Treatment Phase 2
Completed NCT02134314 - C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI Phase 1/Phase 2
Completed NCT02346968 - Evaluation of CAF22 After Renal Transplantation
Completed NCT01794663 - Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function Phase 2
Completed NCT00298181 - YSPSL for Prevention of Delayed Graft Function Part A Phase 1/Phase 2
Not yet recruiting NCT05166460 - Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation N/A
Recruiting NCT03071536 - Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation N/A
Not yet recruiting NCT05513807 - Graft Acute Kidney Injury: Vitamin B3 to Facilitate Renal Recovery In the Early Life of a Transplant Phase 3
Recruiting NCT04005469 - Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation Phase 1/Phase 2
Completed NCT01848249 - Deceased Donor Biomarkers and Recipient Outcomes
Active, not recruiting NCT02474667 - Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney Phase 3
No longer available NCT02026934 - CliniMACS® CD34+ Reagent System for Expanded Access Use N/A
Terminated NCT00217152 - A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors Phase 4
Recruiting NCT05430620 - Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys Phase 3
Completed NCT03864926 - Envarsus in Delayed Graft Function (E-DGF) Phase 4
Recruiting NCT06367205 - Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations N/A
Completed NCT02610296 - QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant Phase 3
Active, not recruiting NCT02568696 - Intra-graft Coagulation Events in Clinical Renal Transplantation and Delayed Graft Function
Recruiting NCT01837043 - Early Conversion From CNI to Belatacept in Renal Transplant Recipients With Delayed and Slow Graft Function Phase 2
Terminated NCT01878786 - A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys Phase 2/Phase 3