NCT00312871

Brief Summary

The purpose of the study is to assess the effect of an early and complete correction of anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure (which involves improper functioning of the kidneys). It also assesses the effect of hemoglobin normalization (correction of anemia) on the need for renal (kidney) replacement therapy, quality of life, blood pressure control, hospital admissions, mortality, cardiovascular events, nutritional status and safety.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2001

Typical duration for phase_4

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

Study Start

First participant enrolled

February 1, 2001

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2010

First QC Date

April 7, 2006

Last Update Submit

May 16, 2011

Conditions

AnemiaRenal Failure, Chronic Renal Failure

Keywords

Chronic renal failureAnemiaRenal replacement therapyEpoetinEpoetin alfaerythropoietinChronic kidney failureend-stage renal disease

Outcome Measures

Primary Outcomes (1)

  • Rate of progression of chronic renal failure over 36 months as measured by at least 2 glomerular filtration rate assessments.

Secondary Outcomes (1)

  • Need for renal replacement therapy; quality of life; blood pressure control; hospital admissions; mortality; cardiovascular events; nutritional status.

Interventions

Epoetin alfaDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a history of chronic renal failure, and at least a 6-month follow-up with at least 3 measurements of serum creatinine
  • patients with a rate of decline in glomerular filtration rate (GFR--a measure of kidney function) below 0.6 mL/min/month
  • patients with a hemoglobin level \<13 g/dL for men and \<12.5 g/dL for women without active blood loss or iron deficiency
  • patients with a glomerular filtration rate (a measure of kidney function) between 25 and 60 mL/min/1.73m2)
  • patients with blood pressure \<=160/100 mm Hg (with or without antihypertensive therapy)

You may not qualify if:

  • Patients with chronic renal failure (kidney dysfunction) associated with inherited polycystic kidney disease
  • patients currently receiving treatment with epoetin for anemia secondary to chronic renal failure, and having a hemoglobin level \>11 g/dL
  • patients receiving epoetin but having a hemoglobin level below 11 g/dL will not be excluded
  • patients with severe hypertension (blood pressure \>= 180/110 mm Hg) within 3 months prior to study entry
  • patients with a history of New York Heart Association (NYHA) class III or IV congestive heart failure within the preceding two years - NYHA class I and II congestive heart failure is accepted
  • patients with a history of ischemic heart disease (deficient blood supply to the heart due to constricted or obstructed arteries)
  • concurrent malignancy
  • patients who have had a transfusion of red blood cells within 30 days prior to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PMID: 36791280DERIVED

Related Links

MeSH Terms

Conditions

AnemiaKidney Failure, Chronic

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesRenal 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)

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

Study Officials

  • Janssen-Cilag S.A.S. Clinical Trial

    Janssen Cilag S.A.S.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 11, 2006

Study Start

February 1, 2001

Study Completion

June 1, 2003

Last Updated

May 17, 2011

Record last verified: 2010-04