An Open-Label Study of the Tolerability and Flexibility of Multi-Dose NeoRecormon Administered by Reco-Pen in Pre-Dialysis Patients With Chronic Renal Anemia.
Overview
- Phase
- Phase 4
- Intervention
- Epoetin Beta
- Conditions
- Anemia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 58
- Primary Endpoint
- Percentage of participantss who change to once weekly NeoRocormon
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients 18-65 years of age
- •Chronic renal failure (Stages I-III)
- •No previous epoetin therapy
Exclusion Criteria
- •Poorly controlled hypertension
- •History or evidence of malignancy
- •Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug
- •Women who are pregnant or breastfeeding
Arms & Interventions
Epoetin Beta
Patients will be administered 3 times (X) 30 International unis per kilogram(IU/Kg body weight per week of eopetin beta subcurtaneously using the device RecoPen. The dosage could be increased every 4 weeks by 3 X20 IU/Kg.
Intervention: Epoetin Beta
Outcomes
Primary Outcomes
Percentage of participantss who change to once weekly NeoRocormon
Time Frame: 10 months
Percentage of participants who changed dose during treatmnent
Time Frame: 10 months
Percentage of participants who withdrew due to inability to use RecoPen
Time Frame: 10 months
Percentage of participants with local intolerabilities (pain/allergic reactions)
Time Frame: 10 months
Secondary Outcomes
- Quality of life evaluated by the Short Form 36(10 months)