Back to resultsA Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Serbia
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, 18-75 years of age;
- end-stage renal disease;
- on renal dialysis >= 3 months;
- receiving NeoRecormon treatment >= 3 months;
- Hb stable and <105g/L, and LVMI >160g/m2.
Exclusion Criteria:
- unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
- use of any ESA other than NeoRecormon;
- acute infection;
- use of iv NeoRecormon.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Hb level, BP.
LVMI ejection fraction, ejection fraction.
Secondary Outcome Measures
SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00413101
Brief Title
A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.
Official Title
An Open-Label Study to Investigate Improvement in Heart Function After Complete Anemia Correction With NeoRecormon in Patients With End-Stage Renal Disease Already Receiving Sub-Optimal Doses of NeoRecormon
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis receiving NeoRecormon, and with a hemoglobin level <105g/L, will be treated with subcutaneous NeoRecormon at a dose determined by the investigator in order to reach (within 3 months) and maintain a hemoglobin level in the range of 120-135g/L. Heart function and quality of life will be measured before and after anemia correction. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
epoetin beta [NeoRecormon]
Intervention Description
At a dose to achieve and maintain an Hb level of 120-135g/L
Primary Outcome Measure Information:
Title
Hb level, BP.
Time Frame
Throughout study
Title
LVMI ejection fraction, ejection fraction.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, 18-75 years of age;
end-stage renal disease;
on renal dialysis >= 3 months;
receiving NeoRecormon treatment >= 3 months;
Hb stable and <105g/L, and LVMI >160g/m2.
Exclusion Criteria:
unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
use of any ESA other than NeoRecormon;
acute infection;
use of iv NeoRecormon.
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
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.
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