NCT00338000

Brief Summary

The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anemia in predialysis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
292

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_4

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

June 1, 2001

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

First QC Date

June 16, 2006

Last Update Submit

January 31, 2011

Conditions

Chronic Renal Failure

Keywords

Chronic renal failureleft ventricular hypertrophyepoetin alfa

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin change - reach of target Hb levels (measured at Visit 1, 2, 3, 4)

Secondary Outcomes (1)

  • Prevention of left ventricular hypertrophy (measured at Visit 3 and 4)

Interventions

Epoetin alfaDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with Hb\<or= 11g/dl
  • Females - using adequate contraceptive method

You may not qualify if:

  • Patients with uncontrolled or severe cardiovascular disease, including recent myocardial infarction, uncontrolled hypertension or congestive heart failure
  • treatment within the previous 6 months with epoetin alfa or any erythropoietin, known hypersensitivity to the product or to any of the ingredients
  • patient not in line with the approved SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, ChronicHypertrophy, Left Ventricular

Interventions

Epoetin Alfa

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 SymptomsCardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Janssen Pharmaceutica N.V. Clinical Trial

    Janssen Pharmaceutica N.V.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

June 1, 2001

Study Completion

May 1, 2005

Last Updated

February 1, 2011

Record last verified: 2011-01