NCT00261521

Brief Summary

The purpose of this study in early hemodialysis patients (on dialysis 3 to 18 months) is to assess the effect of correction versus partial correction of anemia using epoetin alfa on heart pumping function.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
596

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2000

Typical duration for phase_3

Status
completed

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

Study Start

First participant enrolled

February 1, 2000

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
Last Updated

December 3, 2010

Status Verified

December 1, 2010

First QC Date

December 2, 2005

Last Update Submit

December 2, 2010

Conditions

Kidney Failure, ChronicAnemia

Keywords

Kidney failure, ChronicEnd-stage renal diseaseKidney failureAnemiaDialysisEpoetinErythropoetinEpoetin alfa

Outcome Measures

Primary Outcomes (1)

  • Percent change in left ventricular volume index (LVVI) at Week 96.

Secondary Outcomes (1)

  • Percent change at Week 96 in left ventricular mass index (LVMI), development of new heart failure, correlation between change in left ventricular indices and average maintenance hemoglobin, 6-minute walking test, and quality of life.

Interventions

epoetin alfaDRUG

Eligibility Criteria

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

You may qualify if:

  • On hemodialysis for 3 to 18 months and expected to remain on hemodialysis for at least two more years and with a life expectancy of a year or more
  • Kidney transplant patients, whose transplant has failed, and now have been on hemodialysis for 3-18 months, may be eligible for the study, if they are not receiving excessive immunosuppression (e.g., \<=10 mg of steroids/day allowed)
  • Pre-dialysis hemoglobin 8-12 g/dL, inclusive, within the previous month (single reading is sufficient)
  • Stable hemodialysis vascular access, within the previous 3 months
  • No heart disease or asymptomatic heart disease without enlarged heart

You may not qualify if:

  • Heart diseases for which surgical intervention occurred during the previous two years or which may require intervention within the next year
  • Patients with medical conditions likely to affect the response to epoetin
  • Predialysis sitting diastolic blood pressure \>= 100 mmHg on average for the previous month
  • Folate, Vitamin B12, or transferrin deficiency
  • History of seizure within 1 year
  • Transfusion within 30 days prior to study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Parfrey PS, Foley RN, Wittreich BH, Sullivan DJ, Zagari MJ, Frei D. Double-blind comparison of full and partial anemia correction in incident hemodialysis patients without symptomatic heart disease. J Am Soc Nephrol. 2005 Jul;16(7):2180-9. doi: 10.1681/ASN.2004121039. Epub 2005 May 18.

    PMID: 15901766RESULT

  • Williams CE, Curtis BM, Randell EW, Foley RN, Parfrey PS. Cardiac biomarkers and health-related quality of life in new hemodialysis patients without symptomatic cardiac disease. Can J Kidney Health Dis. 2014 Jul 15;1:16. doi: 10.1186/2054-3581-1-16. eCollection 2014.

    PMID: 26038709DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicAnemiaRenal Insufficiency

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2005

First Posted

December 5, 2005

Study Start

February 1, 2000

Study Completion

May 1, 2003

Last Updated

December 3, 2010

Record last verified: 2010-12