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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta | Experimental | Participants will receive 1.2 mcg/kg methoxy polyethylene glycol-epoetin beta given in monthly doses at each visit. Dose will be measured on the basis of the participants Hb level during the study period. The dose administration will be the nearest possible dose using the prefilled syringes containing 50, 75 and 100 mcg/kg Q4W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | Baseline (Week -2 up to Week 0) to Week 28 | |
| Percentage of Participants With Red Blood Cell Transfusion During Treatment Period | Week 0 up to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osmania General Hospital; Department of Nephrology | Hyderabad | Andhra Pradesh | 500012 | India | ||
| Pushpawati Singhania Research Institute; Nephrology |
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|
| 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 |
| New Delhi |
| National Capital Territory of Delhi |
| 110017 |
| India |
| Indraprastha Apollo Hospitals | New Delhi | National Capital Territory of Delhi | 110076 | India |
| Vijayratna Diabetes Diagnosis & Treatment Center | Ahmedabad | 380007 | India |
| M S Ramaiah Memorial Hospital | Bangalore | 560054 | India |
| North Delhi Diabetes Centre | Delhi | 110085 | India |
| MAX Balaji Hospital | Delhi | 110092 | India |
| Dr.Modi's Clinic | Hyderabad | 500001 | India |
| IPGMER & SSKM Hospital; Rheumatology and Clinical Immunology Centre | Kolkata | 700 020 | India |
| Apex Kidney Care Pvt. Ltd., Sushrut Hospital | Mumbai | 400 071 | India |
| Diab Care Centre | Mumbai | 400076 | India |
| Sanjeevani Hospital | Mumbai | 400097 | India |
| Sahyadri Speciality Hospital | Pune | 411004 | India |
| Diabetes Care & Research Centre | Pune | 411011 | India |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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