Anemia
Conditions
Brief summary
This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28 weeks.
Interventions
DRUGMethoxy polyethylene glycol-epoetin beta [Mircera]
Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diabetic nephropathy * Chronic renal anemia with stage III-IV CKD * Not on dialysis and not expected to require dialysis within the next 6 months * Not receiving any ESA in the 2 months prior to study * Adequate iron status
Exclusion criteria
* Transfusion of red blood cells during the previous 2 months * Known or clinical suspicion of pure red cell aplasia * Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication * Haemoglobinopathy * Significant acute or chronic bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP) | EEP (Week 17 up to Week 24) |
| Change in Hb Concentration Between Baseline and EEP | Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24) |
| Percentage of Participants Maintaining Hb Concentration Within the Target Range (10-12 g/dL) During EEP | EEP: (Week 17 up to Week 24) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Red Blood Cell Transfusion During Treatment Period | Week 0 up to Week 24 |
| Percentage of Participants With Adverse Events | Baseline (Week -2 up to Week 0) to Week 28 |
| Percentage of Participants with anti-epoetin antibodies | Baseline (Week-2 up to Week 0) up to Week 28 |
| Short Form-36 Health Survey (SF-36) score | Week 0 to Week 24 |
Countries
India
Outcome results
None listed