UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013268
Receipt number R000015452
Scientific Title Efficacy of anti-RANKL antibody on bone and mineral disorders in post-kidney transplant patients.
Date of disclosure of the study information 2014/04/01
Last modified on 2019/08/31 10:12:06

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Basic information

Public title

Efficacy of anti-RANKL antibody on bone and mineral disorders in post-kidney transplant patients.

Acronym

Anti-RANKL antibody after kidney transplantation

Scientific Title

Efficacy of anti-RANKL antibody on bone and mineral disorders in post-kidney transplant patients.

Scientific Title:Acronym

Anti-RANKL antibody after kidney transplantation

Region

Japan


Condition

Condition

Bone and mineral disorders after kidney transplantation

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Assessment of efficacy and safety of anti-RANKL antibody on bone-mineral disorder after kidney transplantation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Bone mineral density at lumbar vertebrae and femoral neck

Key secondary outcomes

Clinical fracture, bone turn over marker, adverse side effect


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Treatment with ani-RANKL antibody on new kidney transplant recipient

Interventions/Control_2


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

New kidney transplant recipient

Key exclusion criteria

Person incapable of giving informed consent

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Atsushi
Middle name
Last name Suzuki

Organization

Fujita Health University

Division name

Department of Endocrinology and Metabolism

Zip code

470-1192

Address

1-98 Dengakugakubo kutsukakecho Toyoake City Aichi Prefecture

TEL

0562-93-9242

Email

aslapin@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Suzuki

Organization

Fujita Health University

Division name

Deparment of Endocrinology and Metabolism

Zip code

470-1192

Address

1-98 Dengakugakubo kutsukakecho Toyoake City Aichi Prefecture

TEL

0562-93-2139

Homepage URL


Email

aslapin@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

None

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fujita Health University, Research Promotion and Support Headquarters

Address

1-98, Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

Tel

0562-93-2862

Email

kenshien@fujita-hu.ac.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

藤田医科大学病院(愛知県)


Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 01 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

31

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

Completed

Date of protocol fixation

2014 Year 02 Month 13 Day

Date of IRB

2014 Year 02 Month 13 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2019 Year 03 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

2014 Year 02 Month 25 Day

Last modified on

2019 Year 08 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015452


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name