UMIN-CTR Clinical Trial

Public title

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

Acronym

A clinical study of the living renal transplantation with restored kidneys between third parties

Scientific Title

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

Scientific Title:Acronym

A clinical study of the living renal transplantation with restored kidneys between third parties

Region

Japan

Condition

Living renal transplantations between third parties with restored donor kidneys in order to acquire necessary clinical data for expanding renal donor pool and availability in Japan as well as to provide useful medical care for patients who are on dialysis urging for renal transplant and waiting for many years.

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 or occurrence of renal cancer) after renal transplantation with restored donor kidneys to third party recipients

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 on dialysis and willing to receive a restored kidney from a third party
2) Patients eligible for general anesthesia
3) Patients able to understand and sign written informed consent to participate in the clinical study
For Donor:
1) Patients having a small-sized tumor (size: <4 cm) in the kidney and chosen nephrectomy among all the available treatment options and have permitted to transplant the nephrectomized kidney to a third party upon its surgical restoration
2) Patients eligible for general anesthesia
3) Patients able to understand and sign 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 having infectious disease, hemorrhagic ulcer, or malignant cancer
2) Patients having serious vascular lesions (eg. Arteriosclerosis, thromboembolic disease) and currently on treatment
3) Patients not approved by the Institutional Ethics Committee
For Donor:
1) Patients positive for serious infectious disease (eg. HIV, HBV, or HCV)
2) Patients diagnosed as having malignant lymphoma or sarcoma
3) Patients on chemotherapy or radiation therapy for renal cancer prior to the nephrectomy
4) Patients not approved by the Institutional Ethics Committee
(*) Other exclusion criteria defined in the protocol for both recipient and donor may apply.

Target sample size

20

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

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

NCT00980317

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

2009

Year

12

Month

15

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

30

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

2009

Year

12

Month

15

Day

Last modified on

2013

Year

12

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003536