A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.

Roche

Status and phase: Terminated; Phase 3

Conditions: Anemia

Treatments: Drug: Epoetin alfa; Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442416

ML20338

Details and patient eligibility

About

This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic kidney disease stage V;
• on peritoneal dialysis for 3 months prior to screening;
• on epoetin alfa sc >=3 months prior to screening.

Exclusion criteria

• patients expecting to change dialysis modality over course of study;
• patients hospitalized during previous 3 months for any clinically significant condition;
• active malignancy;
• bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
• transfusion of red blood cells within 3 months prior to screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

RO0503821

Experimental group

Description:

Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta \[Mircera\]) subcutaneously (SC) every month for eight months (6 months of titration period \[TP\] and two months of evaluation period \[EP\] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of \>=10.0 gram per decilitre (g/dL) and \<=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Epoetin Alfa

Active Comparator group

Description:

Eligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so.

Treatment:

Drug: Epoetin alfa