Renal prognoses by different target hemoglobin levels achieved by therapy with epoetin beta pegol dosing to chronic kidney disease patients with hyporesponsive anemia to erythropoiesis stimulating agent: multicenter open-label randomized controlled study

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2012
INTERVENTION: Active group: Patients take epoetin beta pegol for 21 months with the target hemoglobin level of 11 g/dL or more. Maintenance group: Patients take epoetin beta pegol for 21 months maintaining a hemoglobin level at enrollment of each patient(range: within +‐1g/dL) CONDITION: Renal anemia in chronic kidney disease PRIMARY OUTCOME: Renal prognosis; Time to events indicated by renal prognoses such as: i) induction of kidney alternative therapy (dialysis or renal‐transplant), ii) decrease in eGFR to <6.0 mL/min/1.73 m2, iii) eGFR declines of 30% and over. SECONDARY OUTCOME: (1) Renal function (the rate of change of eGFR); (2) Cardiovascular events; (3) Safety INCLUSION CRITERIA: (1) Erythropoiesis stimulating agent(ESA) hyporesponsiveness as defined by A) or B): A) Initial phase: 8‐12 weeks after ESA therapy (epoetin alfa and beta dose 6000 IU/W, darbepoetin alfa dose 30 microgram/2W, epoetin beta pegol dose 25 microgram/2W) ‐Hemoglobin (Hgb) level(>=8 g/dL and <11 g/dL) or difference between the Hgb level from baseline must be <1.0 g/dL. B) Maintenance phase:>=12 weeks after ESA therapy ‐Stable Hgb level (>=8 g/dL and <11 g/dL) ‐ESA dose must be within the following ranges: Epoetin alfa and beta dose >= 6000 IU/W (24000IU/4W) Darbepoetin alfa dose >=30 microgram/2W (60 microgram/4W) Epoetin beta pegol dose >=25 microgram/2W (50 microgram/4W) (2) No plan of dialysis induction for six months or more from starting the epoetin beta pegol (3) Age >‐ 20 years at informed consent (4) Obtained written informed consent from the patient for the study parti
Epistemonikos ID: f3dab85e8e2a2588c5011ef7878aca8983fc10d3
First added on: Aug 22, 2024