Back to resultsA Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.
Primary Purpose
Anemia
Status
Terminated
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
epoetin beta [NeoRecormon]
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Percentage of patients achieving target Hb within 20 weeks.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00440063
Brief Title
A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.
Official Title
A Randomized Study to Compare the Safety and Effectiveness of Two Monitoring Schedules to Maintain Hemoglobin Levels and Iron Parameters in Patients With Renal Anemia Receiving NeoRecormon
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
epoetin beta [NeoRecormon]
Primary Outcome Measure Information:
Title
Percentage of patients achieving target Hb within 20 weeks.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Adelaide
Country
Australia
City
Gosford
Country
Australia
City
Herston
Country
Australia
City
Liverpool
Country
Australia
City
Parkville
Country
Australia
City
Perth
Country
Australia
City
Sydney
Country
Australia
City
Tasmania
Country
Australia
City
Woolloongabba
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.
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