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A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.
This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fresenius Medical Care Martinez
Buenos Aires, Argentina
Fresenius Medical Care Morón
Buenos Aires, Argentina
Fresenius Medical Care San Martin
Buenos Aires, Argentina
Fresenuis Medical Care Mansilla
CABA, Argentina
Gosford Hospital; Renal
Gosford, New South Wales, Australia
Renal Research Dr Simon Roger
Gosford, New South Wales, Australia
Cairns Hospital; Renal Services
Cairns, Queensland, Australia
Gold Coast Hospital Department of Pharmacology & Therapeutics
Southport, Queensland, Australia
ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS
Adelaide, South Australia, Australia
Launceston General Hospital; Diabetes and Renal Research Unit
Launceston, Tasmania, Australia
Start Date
December 12, 2008
Primary Completion Date
July 27, 2017
Completion Date
July 27, 2017
Last Updated
August 20, 2019
2,825
ACTUAL participants
Darbepoetin Alfa
DRUG
Epoetin Alfa
DRUG
Epoetin Beta
DRUG
methoxy polyethylene glycol-epoetin beta
DRUG
Lead Sponsor
Hoffmann-La Roche
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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