A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576628

ML20978

Details and patient eligibility

About

This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic renal anemia, with no need for dialysis expected in next 3 months;
• adequate iron status.

Exclusion criteria

• previous epoetin therapy within 12 weeks prior to treatment;
• transfusion of red blood cells during 2 months prior to screening;
• significant acute or chronic bleeding such as overt gastrointestinal bleeding;
• hemolysis;
• folic acid and vitamin B 12 deficiency.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

133 participants in 1 patient group

C.E.R.A

Experimental group

Description:

Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator \[C.E.R.A\]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]