NCT00446576

Brief Summary

The purpose of this study is to assess whether maintaining hemoglobin (Hb) levels at normal or sub-normal levels with Epoetin Alfa can influence the health status, left ventricular mass and quality of life of early renal insufficiency subjects without additional safety concerns.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 1999

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

November 1, 1999

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
Last Updated

February 1, 2011

Status Verified

January 1, 2011

First QC Date

March 12, 2007

Last Update Submit

January 31, 2011

Conditions

Anemia

Keywords

Anemiaearly renal insufficiency

Outcome Measures

Primary Outcomes (1)

  • Absolute change in left ventricular mass index

Secondary Outcomes (1)

  • Incidence of Left Ventricular hypertrophy QoL assessment (FACIT-Fatigue Scale and KDQOL-SFÒ) The change in pulse pressure during the study period. Morbidity and mortality during the study-period Deterioration of renal function Days in hospital

Interventions

Epoetin AlfaDRUG

Eligibility Criteria

Age18 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with early renal insufficiency who are not on haemodialysis
  • A baseline Hb level of \>7.5 mmol/l (120 g/l) but expected to decrease during the coming months. Allowed exceptions: Hb \< 7,5 mmol/l (120 g/l) for a maximum of 6 months. In medical history an Hb \< 7,0 mmol/l (113 g/l) is only allowed for a maximum period of 3 months and in relation to an accidental drop in Hb (f.e. caused by surgery, gastric bleeding etc.)
  • Age: 18 - 73 years, given that patients \>70 years are in good general condition and are expected to complete the 30 months study period
  • Creatinine clearance \< 40 ml/min/1.73 m2 (Cockcroft formula) or creatinin clearance \< 50 ml/min/1.73 m2), given that the clearance and Hb show a downward tendency as demonstrated in the patient files and medical history

You may not qualify if:

  • Presence of clinically significant disease/dysfunction of hepatic, pulmonary, hematological (e.g. sickle cell anaemia, thalassemia, major myelodysplastic syndromes, hemolytic anaemia), neurological, musculo-skeletal, endocrine, gastrointestinal or genitourinary system unrelated to underlying chronic renal failure which in the opinion of the investigator would disqualify the patient from this study
  • Cystic kidney disease
  • Clinical or laboratory evidence of untreated iron, folate or Vitamin B12 deficiency
  • Presence of concomitant malignancy (other than basal cell carcinoma of the skin)
  • Uncontrolled hypertension (i.e. diastolic blood pressure of \> 100 mm Hg)
  • History of seizures
  • Administration of medication known to suppress erythropoiesis (e.g. cytotoxic agents, immuno-suppressive) within one month prior to enrolment. Low dose steroid therapy will be permitted
  • Pregnancy or lactation
  • Known hypersensitivity to Epoetin alfa or one of its components.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AnemiaRenal Insufficiency

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Janssen-Cilag B.V. Clinical Trial

    Janssen-Cilag B.V.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 12, 2007

First Posted

March 13, 2007

Study Start

November 1, 1999

Study Completion

April 1, 2003

Last Updated

February 1, 2011

Record last verified: 2011-01