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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,825
Darbepoetin alfa will be administered as per approved label.
Epoetin alfa will be administered as per approved label.
Epoetin beta will be administered as per approved label.
Participants who are currently not being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta administered at a starting dose of 0.6 mcg/kg body weight once every 2 weeks. Participants who are currently being treated with an ESA will receive methoxy polyethylene glycol-epoetin beta at a dose of 120, 200 or 360 mcg once monthly (based on ESA dose administered in Week -1)
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
Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First
Time frame: Baseline up to approximately 8.5 years
Time to All-Cause Mortality
Time frame: Baseline up to approximately 8.5 years
Time to Non-Fatal and Fatal Myocardial Infarction
Time frame: Baseline up to approximately 8.5 years
Time to Non-Fatal and Fatal Stroke
Time frame: Baseline up to approximately 8.5 years
Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)
Time frame: Baseline up to approximately 8.5 years
Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)
Time frame: Baseline up to approximately 8.5 years
Percentage of Participants With Gastrointestinal Bleeding
Time frame: Baseline up to approximately 8.5 years
Percentage of Participants With Thromboembolic Events
Time frame: Baseline up to approximately 8.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 186 more locations