NCT00319150

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

2.3 years

First QC Date

April 26, 2006

Last Update Submit

February 11, 2009

Conditions

Kidney Failure, ChronicDrug Resistance

Keywords

Erythropoetin resistanceEnd Stage Renal Disease on hemodialysis

Outcome Measures

Primary Outcomes (3)

  • Primary End-points:

    December 31, 2009

  • Eprex® dose at the completion of the study period

    December 31, 2009

  • Hemoglobin at completion of the study period (average of last 2 Hb measurements)

    December 31, 2009

Secondary Outcomes (5)

  • Number of transfusions of packed red cells

    December 31, 2009

  • # of active infections during the study period (active infection is defined in Appendix B)

    December 31, 2009

  • Hospitalization

    December 31, 2009

  • Difference in HRQOL scores using Renal SF-36 scores taken at study start and completion study completion

    December 31, 2009

  • Death

    December 31, 2009

Study Arms (2)

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

Interventions

erythropoietinDRUG

Decrease dosage by 12.5% q 2 weeks according to an algorithm.

Also known as: Epo
Dosage Decrease Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Foothills Hospital

Calgary, Alberta, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Memorial University Medical Centre

St. John's, Newfoundland and Labrador, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

London Helath Sciences Centre

London, Ontario, Canada

Location

Humber River Regional Hosptial

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

ErythropoietinEosinophil Peroxidase

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPeroxidasesOxidoreductasesEnzymesEnzymes and CoenzymesEosinophil Granule ProteinsImmunoproteinsBlood Proteins

Study Officials

  • Karen E Yeates, MD, FRCP(C), MPH

    Queens University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

October 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

CA(7)