UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009970 |
|---|---|
| Receipt number | R000011602 |
| Scientific Title | A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: CANDLE-KIT trial |
| Date of disclosure of the study information | 2013/02/06 |
| Last modified on | 2019/02/10 21:26:38 |
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Basic information
Public title
A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: CANDLE-KIT trial
Acronym
Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: CANDLE-KIT trial
Scientific Title
A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: CANDLE-KIT trial
Scientific Title:Acronym
Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: CANDLE-KIT trial
Region
| Japan |
Condition
Condition
Kidney transplantation
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of anemia correction and vitamin D supplementation on allograft kidney function
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Change in estimated glomerular filtration rate
Key secondary outcomes
- Urine markers of kidney injury at 6 months
1) L-FABP
2) NGAL
3) TGF-beta
4) Protein-creatinine ratio
- The dose of epoetin beta pegol required to maintain the target hemoglobin level
- C-reactive protein
- Change in blood pressure
- Cardiac biomarkers
1) BNP
2) Cardiac troponin-T
- left-ventricular mass index
- Biopsy-proven acute cellular rejection
- Bone-turnover markers
1) 1-84 PTH
2) Bone-type alkaline phosphatase
3) tartrate-resistant acid phosphatase 5b (TRACP-5b)
- Bone mineral density of lumber spine and femoral neck.
- Hypercalcemia (Corrected calcium >=11 mg/dL)
- Event-free survival for the following endpoints
1) Renal composite endpoint (50% increase in serum creatinine, subsequent transplantation, and reinitiation of dialysis)
2) Admission-required cardiovascular events (myocardial infarction, angina, congestive heart failure, stroke, and peripheral artery disease)
3) All-cause death
4) Cancer development or recurrence
5) Infections requiring hospitalization (e.g., Polyomavirus-associated nephropathy, tuberculosis, Pneumocystis carinii pneumonia, cytomegalovirus infection, herpes zoster, bacterial pneumonia)
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Conventional anemia management (Target Hb >=9.5 and <10.5 g/dL) with cholecalciferol (1,000 IU/day)
Interventions/Control_2
Conventional anemia management (Target Hb >=9.5 and <10.5 g/dL) without cholecalciferol
Interventions/Control_3
Aggressive anemia correction (Target Hb >=12.5 and <13.5 g/dL) with cholecalciferol (1,000 IU/day)
Interventions/Control_4
Aggressive anemia correction (Target Hb >=12.5 and <13.5 g/dL) without cholecalciferol
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) >=15 and <60 ml/min per 1.73 m2 of estimated glomerular filtration rate
2) Transplanted allograft kidney at least 1 year before
3) <10.5 g/dL of Hb without iron deficiency (serum ferritin level >=50 ng/ml) or on erythropoiesis stimulating agents treatment regardless of iron status
4) With written informed consent
Key exclusion criteria
1) On anticancer treatment
2) History of ischemic stroke or transient ischemic attack
3) Corrected serum calcium >=10.5 mg/dL
4) HIV virus infection
5) Anticipated refractory hypertension by using epoetin beta pegol
6) In pregnancy and lactation
7) Current use of native vitamin D supplement
8) Patients ineligible according to the investigator's judgement
Target sample size
272
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Hamano |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Comprehensive Kidney Disease Research
Zip code
Address
2-2, Yamada-oka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3857
tsubakihara@kid.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Obi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Nephrology
Zip code
Address
2-2, Yamada-oka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3857
Homepage URL
y-obi@kid.med.osaka-u.ac.jp
Sponsor or person
Institute
CANDLE-KIT Trial Study Group
Institute
Department
Personal name
Funding Source
Organization
Chugai pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
MID Co. Ltd.
Roche diagnostics
Name of secondary funder(s)
Japan Society for the Promotion of Science
The Kidney Foundation, Japan
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01817699
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
市立札幌病院（北海道）、北海道大学病院（北海道）、秋田大学医学部附属病院（秋田県）、仙台社会保険病院（宮城県）、新潟大学（新潟）、自治医科大学（栃木県）、国立水戸医療センター（茨城）、新潟大学（新潟県）、千葉東病院（千葉県）、虎の門病院（東京都）、東邦大学医療センター大森病院（東京都）、東京女子医科大学病院（東京都）、北里大学病院（神奈川県）、聖マリアンナ医科大学病院（神奈川県）、藤田保健衛生大学（愛知県）、名古屋第二赤十字病院（愛知県）、社会保険中京病院（愛知県）、サンシャインM&Dクリニック（岐阜県）、岐阜大学医学部附属病院（岐阜県）、奈良県立医科大学附属病院（奈良県）、大阪市立大学医学部附属病院（大阪府）、大阪府立急性期・総合医療センター（大阪府）、蒼龍会井上病院（大阪府）、愛仁会高槻病院（大阪府）、大阪船員保険病院（大阪府）、伊藤クリニック（大阪府）、日本赤十字社和歌山医療センター（和歌山県）、兵庫県立西宮病院（兵庫県）、岡山医療センター（岡山県）、香川大学（香川県）、熊本赤十字病院（熊本県）、九州大学病院（福岡県）、豊見城中央病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
http://clinicaltrials.gov/ct2/show/NCT01817699?term=NCT01817699&rank=1
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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 05 | Day |
Last modified on
| 2019 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011602
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