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

Hoffmann-La Roche1,228 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,228

Conditions

Anemia

Interventions

Methoxy Polyethylene Glycol-Epoetin Beta

Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (249)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Mobile, Alabama, United States

Unnamed facility

Montgomery, Alabama, United States

Unnamed facility

Hot Springs, Arkansas, United States

Unnamed facility

Covina, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation

Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.

Time frame: Baseline to the end of the study (Up to 49 Months)

Secondary Outcomes

Percentage of Patients Who Had at Least 1 Adverse Event

See the adverse events section of the results for more information.

Time frame: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)