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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025832
Receipt No. R000029649
Scientific Title A clinical study of the restored kidney transplantation from living donors with small renal tumors by nephrectomy
Date of disclosure of the study information 2017/01/24
Last modified on 2017/01/24

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Basic information
Public title A clinical study of the restored kidney transplantation from living donors with small renal tumors by nephrectomy
Acronym A clinical study of the restored kidney transplantation from living donors with small renal tumors by nephrectomy
Scientific Title A clinical study of the restored kidney transplantation from living donors with small renal tumors by nephrectomy
Scientific Title:Acronym A clinical study of the restored kidney transplantation from living donors with small renal tumors by nephrectomy
Region
Japan

Condition
Condition For Donor:small renal tumors
For Recipient:End stage chronic renal failure
Classification by specialty
Nephrology Surgery in general Urology
Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 the restored kidney transplantation from living donors with small renal tumors by nephrectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes For Recipient:
Renal survival after restored kidney transplantation
Key secondary outcomes For Donor and Recipient:
occurrence of cancer and patient survival

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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria for Donor
1)Patients diagnosed as having a small-sized tumor(size:<7cm)in the kidney by image diagnosis and having no lesion except kidney.
2)Patients diagnosed it difficult to partial nephrectomy due to the below reason.
#1:R.E.N.A.L Nephrometry Score more than 10
#2:R.E.N.A.L Nephrometry 4-9 and invasiveness toward the inside(more than 50%)
#3:R.E.N.A.L Nephrometry 4-9 and hematuria
3)
4)Patients who understand the treatment options (partial nephrectomy, renal autotransplantation nephrectomy and so on) and their peculiarity and who chosen nephrectomy
5)Patients notified its name of disease
6)

For Recipient:
1)Patients on dialysis and unable to continue getting dialysis
Patients who desired transplantation
2)Patients able to getting help from family or friend
3)
4)Patients eligible for general anesthesia
5)Patients who understand the advantages and disadvantages of restored kidney transplantation
Appropriate patients as recipients for restored kidney transplantation
6)
Key exclusion criteria For Donor:
1)Patients on chemotherapy or radiation therapy for renal cancer prior to the nephrectomy
2)Patients diagnosed as having malignant lymphoma or sarcoma
3)Patients diagnosed as having malignant lymphoma or sarcoma
Patients who have malignant tumor except kidney
4)Patients for serious infectious disease (eg. HIV, HBV, or HCV) or serious disease
5)Patients not approved by principal investigator, the Institutional Ethics Committee or Restored Kidneys Transplantation Committee

For Recipient:
1)Patients positive for serious infectious disease, bleeding, ulcer malignant tumor and so on
2)Patients who have the complications of the serious vascular disease or circulatory disease and there is any possibility that transplantation make the complications worse.
3)Patients not approved by principal investigator, the Institutional Ethics Committee or Restored Kidneys Transplantation Committee
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Ogawa, MD, PhD
Organization Tokyo-Nishi 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-Nishi 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
Email transplant-office@tokushukai.jp

Sponsor
Institute Tokyo-Nishi Tokushukai Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 24 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 Preinitiation
Date of protocol fixation
2016 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 15 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
2017 Year 01 Month 24 Day
Last modified on
2017 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029649

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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