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REPEAT Study - Resistance to ErythroPoietin Effectiveness Algorithm Trial

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ClinicalTrials.gov Identifier: NCT00319150
Recruitment Status : Terminated (New evidence and trouble recruiting)
First Posted : April 27, 2006
Last Update Posted : February 12, 2009
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by:
Queen's University

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

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug Resistance Drug: erythropoietin Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resistance to ErythroPoietin Effectiveness Algorithm Trial
Study Start Date : October 2006
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Primary End-points: [ Time Frame: December 31, 2009 ]
  2. Eprex® dose at the completion of the study period [ Time Frame: December 31, 2009 ]
  3. Hemoglobin at completion of the study period (average of last 2 Hb measurements) [ Time Frame: December 31, 2009 ]

Secondary Outcome Measures :
  1. Number of transfusions of packed red cells [ Time Frame: December 31, 2009 ]
  2. # of active infections during the study period (active infection is defined in Appendix B) [ Time Frame: December 31, 2009 ]
  3. Hospitalization [ Time Frame: December 31, 2009 ]
  4. Difference in HRQOL scores using Renal SF-36 scores taken at study start and completion study completion [ Time Frame: December 31, 2009 ]
  5. Death [ Time Frame: December 31, 2009 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Karen E. Yeates, Queens University
ClinicalTrials.gov Identifier: NCT00319150     History of Changes
Other Study ID Numbers: DMED-852-05
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Epoetin Alfa
Hematinics