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

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 - RADIANCE-CKD Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008617

Enrollment

500

Registered

2012-08-10

Start date

2012-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal anemia in chronic kidney disease

Interventions

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 he

Eligibility

Sex/Gender

All

Inclusion criteria

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 participation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
(1) Renal function (the rate of change of eGFR) (2) Cardiovascular events (3) Safety	—

Countries

Japan

Contacts

Public ContactKatsuhiko Omote

EP-CRSU Co., Ltd. Clinical Research Promotion Dept.1

prj-radiance-ckd@eps.co.jp03-5842-7480

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026