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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008617
Receipt No. R000010129
Scientific Title 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
Date of disclosure of the study information 2012/08/10
Last modified on 2019/08/21

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Basic information
Public title 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
Acronym RADIANCE-CKD Study
Scientific Title 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
Scientific Title:Acronym RADIANCE-CKD Study
Region
Japan

Condition
Condition Renal anemia in chronic kidney disease
Classification by specialty
Medicine in general Nephrology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the renal prognoses by different target hemoglobin levels achieved by epoetin beta pegol dosing to chronic kidney disease patients with hyporesponsive anemia to erythropoiesis stimulating agent
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 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.
Key secondary outcomes (1) Renal function (the rate of change of eGFR)
(2) Cardiovascular events
(3) Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Active group:
Patients take epoetin beta pegol for 21 months with the target hemoglobin level of 11 g/dL or more.
Interventions/Control_2 Maintenance group:
Patients take epoetin beta pegol for 21 months maintaining a hemoglobin level at enrollment of each patient(range: within +-1g/dL)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Hirakata
Organization Fukuoka Renal Clinic
Division name Division of Nephrology
Zip code 810-0004
Address 4-6-20 Watanabedori, Chuo-ku, Fukuoka 810-0004, Japan
TEL 092-761-4936
Email prj-radiance-ckd@eps.co.jp

Public contact
Name of contact person
1st name Katsuhiko
Middle name
Last name Omote
Organization EP-CRSU Co., Ltd.
Division name Clinical Research Promotion Dept.1
Zip code 162-0814
Address 3F Acropolis Tokyo 6-29 Shinogawamchi, Shinjyuku-ku,Tokyo,162-0814
TEL 03-5842-7480
Homepage URL
Email prj-radiance-ckd@eps.co.jp

Sponsor
Institute Fukuoka Renal Clinic/J-CRSU Co., Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co., Ltd.
Medical Science Dept.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization NPO MINS
Address 401-5-20-9 Mita Minato-ku, Tokyo, 108-0073
Tel 03-6416-1868
Email npo-mins@j-irb.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 07 Month 09 Day
Date of IRB
2012 Year 07 Month 09 Day
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2018 Year 02 Month 28 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 04 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010129

Research Plan
Registered date File name
2019/08/21 研究実施計画書version_4.0_20151005.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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