Back to resultsA Study of NeoRecormon in Patients With Chronic Kidney 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, not on dialysis;
- Hb <110g/L.
Exclusion Criteria:
- unstable hypertension;
- acute infections;
- use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
- myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Hb level, decline in renal function, 24h proteinuria, creatinine clearance.
Secondary Outcome Measures
SAEs, AEs leading to withdrawal, AEs related to NeoRecormon.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00437723
Brief Title
A Study of NeoRecormon in Patients With Chronic Kidney Disease.
Official Title
An Open-Label Study to Investigate the Effect of NeoRecormon on Hemoglobin Level and Renal Function in Patients With Chronic Kidney Disease, Stage 2-4
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
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 2 arm study will compare the level of anemia, and the decline in renal function, between patients receiving NeoRecormon, and those not receiving it. Patients with chronic kidney disease, stage 2-4, and not receiving dialysis, will be randomized 2:1 to a group receiving NeoRecormon (at a dose determined by the investigator to achieve and maintain an Hb level of 120-135 g/L), or to a control group not receiving NeoRecormon. 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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
epoetin beta [NeoRecormon]
Intervention Description
At a dose to achieve and maintain an Hb level of 120-135g/dL.
Primary Outcome Measure Information:
Title
Hb level, decline in renal function, 24h proteinuria, creatinine clearance.
Time Frame
Throughout study
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, not on dialysis;
Hb <110g/L.
Exclusion Criteria:
unstable hypertension;
acute infections;
use of i.v. NeoRecormon, or use of any other ESA beside NeoRecormon;
myocardial infarction, unstable angina or venous thrombosis within 6 months before start of treatment.
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
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
A Study of NeoRecormon in Patients With Chronic Kidney Disease.
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