UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokushukai Medical Group

Institute

Department

Personal name

Organization

Tokushukai Medical Group

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2010

Year

02

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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