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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Epoetin alfa; Drug: Methoxy Polyethylene Glycol-Epoetin Beta; Drug: Epoetin beta; Drug: Darbepoetin alfa

• Registration Number: NCT00090753
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2004-09-03
• Study First Submitted QC: 2004-09-03
• Study First Posted: 2004-09-06
• Study Start: 2004-10
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-12-01
• Results First Submitted QC: 2011-12-01
• Results First Posted: 2012-01-05
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1228

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator ESA	Epoetin alfa	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.
Methoxy Polyethylene Glycol-Epoetin Beta	Methoxy Polyethylene Glycol-Epoetin Beta	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.
Comparator ESA	Epoetin beta	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.
Comparator ESA	Darbepoetin alfa	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation	Baseline to the end of the study (Up to 49 Months)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Had at Least 1 Adverse Event	From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)	See the adverse events section of the results for more information.