UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Factorial Randomized Controlled Trial of Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients: CANDLE-KIT trial
Title of the study (Brief title)	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	Takayuki Hamano
Organization	Osaka University Graduate School of Medicine
Division name	Department of Comprehensive Kidney Disease Research
Address	2-2, Yamada-oka, Suita, Osaka 565-0871, Japan
TEL	06-6879-3857
Email	tsubakihara@kid.med.osaka-u.ac.jp

Public contact
Name of contact person	Yoshitsugu Obi
Organization	Osaka University Graduate School of Medicine
Division name	Department of Nephrology
Address	2-2, Yamada-oka, Suita, Osaka 565-0871, Japan
TEL	06-6879-3857
Homepage URL
Email	y-obi@kid.med.osaka-u.ac.jp

Sponsor
Institute	CANDLE-KIT Trial Study Group
Institute
Department

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

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 02 Month 05 Day
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

Related information
URL releasing protocol	http://clinicaltrials.gov/ct2/show/NCT01817699?term=NCT01817699&rank=1
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011602