Anemia
Conditions
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.
Interventions
At a dose to achieve and maintain an Hb level of 120-135g/dL.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb level, decline in renal function, 24h proteinuria, creatinine clearance. | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. | Throughout study |
Countries
Serbia
Outcome results
None listed