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REPEAT Study - Resistance to ErythroPoietin Effectiveness Algorithm Trial

This study has been terminated.
(New evidence and trouble recruiting)
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00319150
First received: April 26, 2006
Last updated: February 11, 2009
Last verified: February 2009
  Purpose

A strategy for optimizing erythropoietin therapy in patients with erythropoietin resistance. A multi-centered, open-label, randomized, controlled trial.


Condition Intervention Phase
Kidney Failure, Chronic
Drug Resistance
Drug: erythropoietin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Resistance to ErythroPoietin Effectiveness Algorithm Trial

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Primary End-points: [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]
  • Eprex® dose at the completion of the study period [ Time Frame: December 31, 2009 ] [ Designated as safety issue: No ]
  • Hemoglobin at completion of the study period (average of last 2 Hb measurements) [ Time Frame: December 31, 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of transfusions of packed red cells [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]
  • # of active infections during the study period (active infection is defined in Appendix B) [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]
  • Hospitalization [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]
  • Difference in HRQOL scores using Renal SF-36 scores taken at study start and completion study completion [ Time Frame: December 31, 2009 ] [ Designated as safety issue: No ]
  • Death [ Time Frame: December 31, 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: October 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care
Epo dose to remain constant throughout study
Active Comparator: Dosage Decrease Arm
Arm 2 is to have an decrease of erythropoietin at regular intervals.
Drug: erythropoietin
Decrease dosage by 12.5% q 2 weeks according to an algorithm.
Other Name: Epo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written informed consent
  • Adult patients > 18 years old with current Epoetin Alpha dose >250 units/kg/wk
  • Hemoglobin >90g/L or <130g/L
  • Patients whom a temporary fall in Hb of up to 10g/L is deemed safe
  • Patients not expected to have a change in the type of Epo or route of Epo therapy for the duration of the Study period

Exclusion Criteria:

  • Known iron deficiency (% saturation <20 or ferritin <100)
  • Vit B12 or folate deficiency (levels below normal limit for centre lab)
  • Known malignancy (solid organ, leukemia or multiple myeloma)
  • Jehovah's witness patients/those who refuse transfusion
  • Expected to die in the next 6 months
  • On dialysis less than 3 months
  • Temporary (not tunneled) dialysis access catheter
  • Pure red cell aplasia
  • High likelihood of early withdrawal or interruption of the study (eg. severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening)
  • Planned major elective surgery during the study period
  • Pregnancy or breast-feeding
  • Women of child-bearing potential without effective contraception (abstinence, oral contraceptives, diaphragm, IUD)
  • Administration of another investigational drug within 4 weeks before screening or planned during study period
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319150

Locations
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Canada, Newfoundland and Labrador
Memorial University Medical Centre
St. John's, Newfoundland and Labrador, Canada
Canada, Ontario
Kingston General Hospital
Kingston, Ontario, Canada
London Helath Sciences Centre
London, Ontario, Canada
Humber River Regional Hosptial
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
Queen's University
Ortho Biotech, Inc.
Investigators
Principal Investigator: Karen E Yeates, MD, FRCP(C), MPH Queens University
  More Information

No publications provided

Responsible Party: Dr. Karen E. Yeates, Queens University
ClinicalTrials.gov Identifier: NCT00319150     History of Changes
Other Study ID Numbers: DMED-852-05
Study First Received: April 26, 2006
Last Updated: February 11, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
Erythropoetin resistance
End Stage Renal Disease on hemodialysis

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014