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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002899
Receipt No. R000003536
Scientific Title A clinical study of the living-unrelated renal transplantation with restored kidneys (interventional trial)
Date of disclosure of the study information 2009/12/15
Last modified on 2013/12/16

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Basic information
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
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

Objectives
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

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 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

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
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
Institute Tokushukai Medical Group
Institute
Department

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 NCT00980317
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
2009 Year 12 Month 15 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 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
Other related information

Management information
Registered date
2009 Year 12 Month 15 Day
Last modified on
2013 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003536

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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