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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020597
Receipt No. R000023776
Scientific Title Effect of 1-year cholecalciferol supplementation from early post-transplant preiod in kidney transplant recipients: a randomized controlled trial
Date of disclosure of the study information 2016/01/17
Last modified on 2019/07/24

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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
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 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
2019 Year 07 Month 24 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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