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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003257
Receipt No. 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

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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
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 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
URL(English) https://upload.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


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