UMIN-CTR Clinical Trial

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

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

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

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

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

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

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

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

Institute

Tokushukai Medical Group

Institute

Department

Personal name

Organization

Tokushukai Medical Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

01

Month

24

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

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 related information

Registered date

2017

Year

01

Month

24

Day

Last modified on

2022

Year

08

Month

02

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029649