A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Family Members

October 13, 2009 updated by: Tokushukai Medical Group

A Clinical Study of the Living-related Renal Transplantation With Restored Kidneys (Interventional Trial)

Approximately 30,000 new patients are introduced into dialysis and about 20,000 of them die every year in Japan. At present, about 300,000 patients are on dialysis and more than 10,000 patients are registered with the Japan Organ Transplant Network (JOTN) with the hope for a renal transplantation. If the renal function is restored by transplantation, the quality of life (QOL) improves and more than 90% are reportedly comeback to their normal life activities and get relieved from the burden of dialysis. Furthermore, it can reduce the dialysis related medical cost by as much as 50%. However, only about 1,000 renal transplantation cases are annually carried out in Japan. Among them, 80-85% are living renal transplantations offered by family members or relatives, and the rest are from deceased donors.

Due to the fact that the number of deceased donors are scarce and only living renal transplantations between the family members or relatives are currently allowed in Japan, the approximate waiting time to receive a renal transplantation is 16 years. For that reason, many patients travel abroad to receive a renal transplantation.

There are reports that total nephrectomies are performed as a treatment for small size (4 cm or less) renal tumors, renal stones, ureteral tumors and ureteral strictures in many cases and that many of these nephrectomized kidneys can be successfully transplanted after surgical restoration with satisfactory results. However, due to the lack of necessary evidence it is currently not allowed in Japan.

Therefore, the investigators planned the present clinical study to evaluate the curative efficacy (renal function, QOL) and safety (side effects, complications or occurrence of renal cancer) of living renal transplantations between family members and relatives with restored donor kidneys after the surgical removal or repairment of a small size (4 cm or less) renal tumor or renal stone, ureteral tumor or ureteral stricture, 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 our patients who are on dialysis for many years due to the renal failure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Procedure: Restored Kidney Transplant Between Family Members

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- Ehime
  - Uwajima, Ehime, Japan, 798-0003
    - Recruiting
    - Uwajima Tokushukai Hospital
- Tokyo
  - Akishima City, Tokyo, Japan, 196-0003
    - Recruiting
    - Tokyo-West Tokushukai Hospital Transplant Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

A) Recipient:

Patients who are suffering from renal failure and are willing to receive a restored kidney from a family member
Patients who are eligible for general anesthesia
Patients who have given written informed consent to participate in the study

B) Donor:

Potential donors who are incidentally diagnosed with small renal tumor (size: <4 cm) or renal stone, ureteral tumor or ureteral stricture and have permitted to transplant the kidney to a family member upon its surgical restoration
Patients who are eligible for general anesthesia
Patients who have given written informed consent to participate in the study

Exclusion Criteria:

A) Recipient:

Patients who have infectious disease, hemorrhagic ulcer, or malignant cancer
Patients who have serious vascular lesions (eg. arteriosclerosis, thromboembolic disease) and are currently on treatment
Patients who were disapproved by the Institutional Ethics Committee

B) Donor:

Patients who have tested positive for serious infectious disease (eg. HIV, HBV, or HCV)
Patients who were diagnosed with malignant lymphoma or sarcoma
Patients who were on chemotherapy or radiation therapy for renal cancer prior to the nephrectomy
Patients who were disapproved by the Institutional Ethics Committee

(*) Other inclusion/exclusion criteria defined in the protocol for both recipient and donor may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of curative efficacy (renal function and QOL) and safety (side effects, complications) after renal transplantation with restored kidneys between family members Time Frame: 12 Months	12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokushukai Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2014

Study Completion (ANTICIPATED)

June 1, 2014

Study Registration Dates

First Submitted

October 9, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (ESTIMATE)

October 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)