UMIN-CTR Clinical Trial

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	A kidney repaired after resection of the tumour part from a kidney removed from a case of renal tumour is transplanted as a donor kidney into a fairly impartially selected haemodialysis patient and its therapeutic efficacy and safety is evaluated
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	For Recipient: Renal viability rate from post-renal transplantation to 5 years post-operatively
Key secondary outcomes	For Donor and Recipient: occurrence of cancer and patient survival from post-renal transplantation to 5 years post-operatively

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.Cases with a small renal tumour,less than 7 cm in diameter, suspected to be a solitary renal cell carcinoma on imaging diagnosis by abdominal echo, thoracoabdominal CT or abdominal MRI, with no other lesions on imaging other than the kidney. 2.Cases in which partial nephrectomy is not indicated for the following reasons. 2.1. renal tumour less than 4 cm, so-called T1a, when partial nephrectomy is considered difficult for the following reasons: 2.1.1. or 2.1.2. or 2.1.3. 2.1.1. with a R.E.N.A.L Nephrometry Score of 10 or more 2.1.2.R.E.N.A.L Nephrometry Score from 4 to 9 with an inward extension of more than 50%. 2.1.3. R.E.N.A.L Nephrometry Score from 4 to 9 with haematuria 2.2. renal tumour greater than 4 cm and less than 7 cm so called T1b cases 3. the patient's age is over 40 years. 4. the appropriateness of nephrectomy is understood prior to the explanation about the study and the patient is willing to undergo nephrectomy. 5. the patient has been informed of the name and condition of the disease. 6. is able to give consent to participate in the study after having been informed in the donor's explanatory and consent documents. For Recipient: 1. The patient is on dialysis treatment but is unable to maintain chronic dialysis treatment and wishes to have a kidney transplant. 2. Willing to undergo transplantation of their own volition and have the cooperation of family, friends, etc. 3. The patient is over 40 years of age. 4. The anaesthesiologist has judged that the patient can undergo surgery under general anaesthesia. 5. The patient has been informed of and understands the advantages and disadvantages of transplanting a repaired kidney and is considered a suitable recipient for a repaired kidney transplant. 6. The patient is able to give consent for renal transplantation after explanation in the explanatory and consent documents for the recipient.
Key exclusion criteria	For Donor: 1. Patients who have received anti-cancer drugs (including molecular targeted drugs, cytokines, etc.) or other drugs within one month of nephrectomy. 2. Patients with a history of irradiation of the kidney to be removed. 3. Suspected renal tumours such as malignant lymphoma or sarcoma, or malignant tumours outside the kidney. 4. Comorbid infections (e.g. HIV, HBV, HCV) and serious illnesses. 5. Cases in which partial nephrectomy is deemed appropriate. 6. Cases other than those listed above, where the principal investigator performing the nephrectomy, the ethics review committee of the nephrectomy facility or the restorative renal transplantation review committee considers the case inappropriate as a subject. For Recipient: 1.The patient has an active infection, bleeding ulcer or malignancy. 2. The patient has a severe vascular or circulatory disorder (e.g. aortic aneurysm, cerebral thrombosis, myocardial infarction, thrombosis, pulmonary embolism), which may be exacerbated by transplantation. 3. Patients other than those listed above who are deemed inappropriate for inclusion by the transplant facility's principal investigator, the transplant facility's ethical review committee or the restorative renal transplant review committee.
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Yoshihide Middle name Last name Ogawa, MD, PhD
Organization	Uwajima Tokushukai Hospital
Division name	Department of Urology
Zip code	798-0003
Address	2-6-24 Sumiyoshi-cho, Uwajima city, Ehime 798-0003, Japan
TEL	0895-22-25811
Email	transplant-office@tokushukai.jp

Public contact
Name of contact person	1st name Junji Middle name Last name Natsuhara
Organization	Uwajima Tokushukai Hospital
Division name	Department of Clinical trial
Zip code	798-0003
Address	2-6-24 Sumiyoshi-cho, Uwajima city, Ehime 798-0003, Japan
TEL	0895-22-2811
Homepage URL
Email	natsuhara.crc@tokushukai.jp

Sponsor
Institute	Tokushukai Medical Group
Institute
Department

Funding Source
Organization	Tokushukai Medical Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokushukai Group Ethical Committee
Address	1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel	03-3263-4801
Email	mirai-ec1@mirai-iryo.com

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	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 28 Day
Date of IRB	2016 Year 01 Month 20 Day
Anticipated trial start date	2017 Year 06 Month 15 Day
Last follow-up date	2029 Year 06 Month 30 Day
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	2022 Year 08 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029649