UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003257
Receipt number R000003939
Scientific Title A clinical study of living-related renal transplantation with restored kidneys (interventional trial)
Date of disclosure of the study information 2010/02/25
Last modified on 2013/08/27 15:06:22

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Basic information

Public title

A clinical study of living-related renal transplantation with restored kidneys (interventional trial)

Acronym

A clinical study of living renal transplantation with restored kidneys between family members

Scientific Title

A clinical study of living-related renal transplantation with restored kidneys (interventional trial)

Scientific Title:Acronym

A clinical study of living renal transplantation with restored kidneys between family members

Region

Japan


Condition

Condition

Living renal transplantations between family members with restored donor kidneys in order to acquire necessary clinical data for potential enrichment of the renal donor pool in Japan as well as to develop useful medical care for patients who are on dialysis for many years due to the renal failure.

Classification by specialty

Surgery in general Urology Operative medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of curative efficacy (renal function and QOL) and safety (side effects, complications) after renal transplantation with restored donor kidneys between family members

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Renal function, QOL, side effects, complications or occurrence of renal cancer

Key secondary outcomes



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

Maneuver

Interventions/Control_1

Surgery, restored kidney transplantation

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

For Recipient:
1) Patients who are suffering from renal failure and are willing to receive a restored kidney from a family member
2) Patients who are eligible for general anesthesia
3) Patients who have given written informed consent to participate in the study
For Donor:
1) Potential donors who are incidentally diagnosed with small renal tumor (size: <4 cm) or renal stone, ureteral tumor or ureteral stricture and have accepted transplanting the kidney to a family member upon its surgical restoration
2) Patients who are eligible for general anesthesia
3) Patients who have given written informed consent to participate in the study
(*) Other inclusion criteria defined in the protocol for both recipient and donor may apply.

Key exclusion criteria

For Recipient:
1) Patients who have active infectious disease, active hemorrhagic ulcer, or malignant cancer
2) Patients who have serious cardiovascular diseases (eg. arteriosclerosis, thromboembolic disease) and are currently on treatment
3) Patients who were disapproved by the Institutional Ethics Committee (or Institutional Review Board)
For Donor:
1) Patients who have positive tests for serious infectious disease (eg. HIV, HBV, or HCV)
2) Patients who were diagnosed as having malignant lymphoma or sarcoma
3) Patients who were on chemotherapy or radiation therapy prior to nephrectomy for renal cancer
4) Patients who were disapproved by the Institutional Ethics Committee
(*) Other exclusion criteria defined in the protocol for both recipient and donor may apply.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihide Ogawa, MD, PhD

Organization

Tokyo-West Tokushukai Hospital

Division name

Department of Urology

Zip code


Address

3-1-1 Matsubara-cho, Akishima city, Tokyo 196-0003, Japan

TEL

042-500-4433

Email

transplant-office@tokushukai.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihide Ogawa, MD, PhD

Organization

Tokyo-West Tokushukai Hospital

Division name

Department of Urology (Transplant Office)

Zip code


Address

3-1-1 Matsubara-cho, Akishima city, Tokyo 196-0003, Japan

TEL

042-500-4433

Homepage URL

http://www.tokyonishi-hp.or.jp/

Email

transplant-office@tokushukai.jp


Sponsor or person

Institute

Tokushukai Medical Group

Institute

Department

Personal name



Funding Source

Organization

Tokushukai Medical Group

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

YES

Study ID_1

NCT00994188

Org. issuing International ID_1

ClinicalTrials.gov

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2010 Year 02 Month 25 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

Open public recruiting

Date of protocol fixation

2009 Year 06 Month 17 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 02 Month 25 Day

Last modified on

2013 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003939


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name