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

Not Applicable

• Conditions: Renal anemia in chronic kidney disease

• Registration Number: JPRN-UMIN000008617
• Lead Sponsor: Fukuoka Renal Clinic/J-CRSU Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-10
• Study Completion: 2017-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Anemia for other reasons than the renal anemia: Complication of apparent hemorrhagic lesion, hematologic disease (e.g. leukemia, malignant lymphoma, myelodysplastic syndrome, aplastic anemia), apparent chronic inflammation (e.g. rheumatoid arthritis, inflammatory bowel disease), or being on myelosuppressive therapy (chemotherapy or radiotherapy) for malignant tumor (2) Iron deficiency: Serum ferritin <100 ng/mL and transferrin saturation (TSAT) <20% (3) Received renal-transplant (4) eGFR <6.0 mL/min/1.73 m2 (5) Hypersensitivity to epoetin beta pegol, erythropoietin, or darbepoetin alfa (6) Pregnancy, nursing or planning to become pregnant during the study (women only) (7) Participation in other clinical trials at enrollment (8) Judged as ineligible in the opinion of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified