A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Epoetin beta; Drug: Epoetin alfa; Drug: Methoxy Polyethylene Glycol-Epoetin Beta; Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090753

BH18387

Details and patient eligibility

About

This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.

Enrollment: 1,228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Adult patients (≥ 18 years old) with chronic renal anemia
• Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484]
• Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
• Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) < 10%

Exclusion criteria

• Poorly controlled hypertension
• History of epileptic seizure
• Pure red cell aplasia
• Chronic congestive heart failure [New York Heart Association (NYHA) IV]
• High likelihood of early withdrawal or interruption of the study
• Active malignant disease (except non-melanoma skin cancer)
• Life expectancy less than 12 months
• Pregnancy or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,228 participants in 2 patient groups

Methoxy Polyethylene Glycol-Epoetin Beta

Experimental group

Description:

Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.

Treatment:

Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Comparator ESA

Active Comparator group

Description:

Patients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.

Treatment:

Drug: Epoetin beta

Drug: Epoetin alfa

Drug: Darbepoetin alfa