UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025832
Receipt number 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 2022/08/02 17:05:41

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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

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 or person

Institute

Tokushukai Medical Group

Institute

Department

Personal name



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

Value
https://center6.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