UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020597 |
|---|---|
| Receipt number | 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 | 2021/01/19 09:19:32 |
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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
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
tsujita4850@yahoo.co.jp
Sponsor or person
Institute
Nagoya Daini Red Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023776
