UMIN-CTR Clinical Trial

Basic information
Public title	Effect of 1-year cholecalciferol supplementation from early post-transplant preiod in kidney transplant recipients: a randomized controlled trial
Acronym	Cholecalciferol supplementation from early period of kidney transplantation
Scientific Title	Effect of 1-year cholecalciferol supplementation from early post-transplant preiod in kidney transplant recipients: a randomized controlled trial
Scientific Title:Acronym	Cholecalciferol supplementation from early period of kidney transplantation
Region	Japan

Condition
Condition	kidney transplantation
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate clinical efficacy and safety of cholecalciferol supplementation from early period of kidney transplantation (KTx)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in estimated glomerular filtration rate at 1 year after KTx with adjustment for baseline values
Key secondary outcomes	1. Urinary kidney injury biomarkers (i.e., L-FABP and/or urinary protein/creatinine) at 6 months and 12 months after KTx 2. Pathophysiological findings on transplanted kidney at 12 months after KTx 3. Body compositions at 6 months and 12 months after transplantation 4. Bone metabolic markers and bone mineral density at 12 months after KTx 5. Prevalence of the development of hypercalcemia (corrected serum calcium>=11mg/dL) 6. Hospitalization-requiring infection-free survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral Cholecalciferol 1 capsule containing 4000 IU/day
Interventions/Control_2	Placebo
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. eGFR >= 30 ml/min/1.73m2 2. <1 month after kidney transplantation 3. With written informed concent 4. Living kidney transplant recipients at Nagoya Red Cross Hospital
Key exclusion criteria	1. On supplementation with native vitamin D (i.e., cholecalciferiol or ergocaliferol) 2. Corrected calcium >= 11.0 mg/dL 3. Patients judged to be inappropriate by the physician in charge
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yoshihiko Middle name Last name Watarai
Organization	Nagoya Daini Red Cross Hospital
Division name	Transplant Surgery
Zip code	466-8650
Address	2-9 Myoken-cho Nagoya-shi Aichi
TEL	052-832-1121
Email	tsujita4850@yahoo.co.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Tsujita
Organization	Nagoya Daini Red Cross Hospital
Division name	Transplant Surgery
Zip code	466-8650
Address	2-9 Myoken-cho Nagoya-shi Aichi
TEL	052-832-1121
Homepage URL
Email	tsujita4850@yahoo.co.jp

Sponsor
Institute	Nagoya Daini Red Cross Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine Department of Pathophysiology, Tokyo Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagoya Daini Red Cross Hospital
Address	2-9 Myoken-cho Nagoya-shi Aichi
Tel	052-832-1121
Email	nmatsui@nagoya2.jrc.or.jp

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	名古屋第二赤十字病院(愛知県)　大阪大学(大阪府)　東京医科大学(東京都)

Other administrative information
Date of disclosure of the study information	2016 Year 01 Month 17 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	193
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	submitted
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	No longer recruiting
Date of protocol fixation	2015 Year 10 Month 15 Day
Date of IRB	2015 Year 10 Month 15 Day
Anticipated trial start date	2016 Year 01 Month 17 Day
Last follow-up date	2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 01 Month 16 Day
Last modified on	2021 Year 01 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023776