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

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 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

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

Value
https://center6.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