UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008617 |
|---|---|
| Receipt number | 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 09:27:27 |
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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
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
prj-radiance-ckd@eps.co.jp
Sponsor or person
Institute
Fukuoka Renal Clinic/J-CRSU Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
