REPEAT Study - Resistance to ErythroPoietin Effectiveness Algorithm Trial - Full Text View

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 III

MedlinePlus related topics:

Kidney Failure

ChemIDplus related topics:

Epoetin alfa Erythropoietin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title:	Resistance to ErythroPoietin Effectiveness Algorithm Trial

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 ]

Estimated Enrollment:	72
Study Start Date:	October 2006
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Standard of Care: No Intervention Epo dose to remain constant throughout study
Dosage Decrease Arm: Active Comparator 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.

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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

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

Contacts


Contact: Joanne C Van Luven, R.N.	(613) 549-6666 ext 6823	vanluvj2@kgh.kari.net

Contact: Karen A Mahoney, R.N.	(613) 533-2012	mahoneyk@post.queensu.ca

Locations


Canada, Alberta
	Foothills Hospital	Recruiting
	Calgary, Alberta, Canada
	Contact: Braden Manns
	Contact: Bruce Culleton

Canada, British Columbia
	St. Paul's Hospital	Recruiting
	Vancouver, British Columbia, Canada
	Contact: Deborah Rosenbaum
	Contact: Adeera Levin

Canada, Newfoundland and Labrador
	Memorial University Medical Centre	Not yet recruiting
	St. John's, Newfoundland and Labrador, Canada
	Contact: Bendan Barrett

Canada, Ontario
	London Helath Sciences Centre	Recruiting
	London, Ontario, Canada
	Contact: Louise Moist
	Kingston General Hospital	Recruiting
	Kingston, Ontario, Canada
	Contact: Joanne C Van Luven, RN 613-549-6666 ext 6823 vanluvj2@kgh.kari.net
	Contact: Karen Mahoney, RN 613-533-2012 mahoneyk@post.queensu.ca
	Principal Investigator: Karen E Yeates, MD,FRCP(C),MPH
	Humber River Regional Hosptial	Not yet recruiting
	Toronto, Ontario, Canada
	Contact: David Mendelssohn
	Contact: Gavril Hercz
	St. Michael's Hospital	Not yet recruiting
	Toronto, Ontario, Canada
	Contact: Phil McFarlane
	Sunnybrooke and Women's Hospital	Withdrawn
	Toronto, Ontario, Canada
	Ottawa General Hospital	Withdrawn
	Ottawa, 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

Responsible Party:	Queens University ( Dr. Karen E. Yeates )
Study ID Numbers:	DMED-852-05
First Received:	April 26, 2006
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00319150
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Queen's University:

Erythropoetin resistance

End Stage Renal Disease on hemodialysis

Study placed in the following topic categories:

Epoetin Alfa

Renal Insufficiency

Urologic Diseases

Renal Insufficiency, Chronic

Kidney Failure, Chronic

Kidney Diseases

Kidney Failure

Additional relevant MeSH terms:

Hematinics

Therapeutic Uses

Hematologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	Queen's University Ortho Biotech, Inc.
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00319150