Anemia
Conditions
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.
Interventions
At a dose to achieve and maintain an Hb level of 120-135g/L
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
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; * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb level, BP. | Throughout study |
| LVMI ejection fraction, ejection fraction. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| SAEs, AEs leading to withdrawal, AEs related to NeoRecormon. | Throughout study |
Countries
Serbia
Outcome results
None listed