A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.

Roche

Status and phase: Terminated; Phase 3

Conditions: Anemia

Treatments: Drug: epoetin alfa; Drug: methoxy polyethylene glycol-epoetin beta; Drug: darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454246

ML20337

Details and patient eligibility

About

This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin alfa, and who are transitioning from chronic kidney disease stage 4 through dialysis. Patients will be randomized either to receive Mircera or to remain on their existing therapy; the initial monthly dose of subcutaneous (sc) Mircera (120-360 micrograms) will be based on the average weekly dose of epoetin alfa or darbepoetin alfa administered in the week preceding the switch to Mircera. At the initiation of dialysis, patients in the Mircera group will receive monthly intravenous (iv) Mircera at a starting dose based on their previous (sc) dose, and those in the control group will receive weekly (iv) epoetin alfa. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic kidney disease stage IV not requiring dialysis;
• expected to initiate dialysis within 18 months;
• 15<=Glomerular Filtration Rate (GFR)<=29.

Exclusion criteria

• failing renal allograft in place;
• acute or chronic bleeding within 8 weeks prior to screening;
• transfusion of red blood cells within 8 weeks prior to screening;
• poorly controlled hypertension;
• immunosuppressive therapy in the 12 weeks prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 3 patient groups

methoxy polyethylene glycol-epoetin beta

Experimental group

Description:

120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta

Epoetin alfa

Active Comparator group

Description:

Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.

Treatment:

Drug: epoetin alfa

Darbepoetin alfa

Active Comparator group

Description:

Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study. Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL.

Treatment:

Drug: darbepoetin alfa