A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
|ClinicalTrials.gov Identifier: NCT00090753|
Recruitment Status : Completed
First Posted : September 6, 2004
Results First Posted : January 5, 2012
Last Update Posted : February 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Anemia||Drug: Methoxy Polyethylene Glycol-Epoetin Beta Drug: Epoetin alfa Drug: Epoetin beta Drug: Darbepoetin alfa||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1228 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Experimental: 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.
Drug: 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.
Active Comparator: Comparator ESA
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.
Drug: Epoetin alfa
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
Drug: Epoetin beta
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
Drug: Darbepoetin alfa
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
- Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation [ Time Frame: 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.
- Percentage of Patients Who Had at Least 1 Adverse Event [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090753
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|Study Director:||Clinical Trials||Hoffmann-La Roche|