NCT00440063

Brief Summary

This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

9 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
Last Updated

December 20, 2007

Status Verified

December 1, 2007

First QC Date

February 23, 2007

Last Update Submit

December 18, 2007

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients achieving target Hb within 20 weeks.

Secondary Outcomes (1)

  • Efficacy: % of patients exceeding upper Hb target; % who fail to reach target Hb; median time to achieve Hb target; dose of NeoRecormon required to meet target Hb concentration; % who maintain target iron parameters. Safety: AEs, SAEs.

Interventions

epoetin beta [NeoRecormon]DRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients, 18-80 years of age;
  • stage 3-4 chronic kidney disease (eGFR 15-60mL/min);
  • Hb \<100g/L, TSAT\>=20%, and ferritin \>=100 mcg/L at screening.

You may not qualify if:

  • anticipating to go on renal replacement therapy;
  • anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant;
  • uncontrolled hypertension;
  • congestive heart failure;
  • active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

Adelaide, Australia

Location

Unknown Facility

Gosford, Australia

Location

Unknown Facility

Herston, Australia

Location

Unknown Facility

Liverpool, Australia

Location

Unknown Facility

Parkville, Australia

Location

Unknown Facility

Perth, Australia

Location

Unknown Facility

Sydney, Australia

Location

Unknown Facility

Tasmania, Australia

Location

Unknown Facility

Woolloongabba, Australia

Location

MeSH Terms

Conditions

Anemia

Interventions

epoetin beta

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    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

February 23, 2007

First Posted

February 26, 2007

Last Updated

December 20, 2007

Record last verified: 2007-12

Locations

AU(9)