UnknownNot Applicable

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

Japan5 participantsStarted 2009-07

Plain-language summary

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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of curative efficacy (renal function and QOL) and safety (side effects, complications) after renal transplantation with restored kidneys between family members

Timeframe: 12 Months

Trial details

NCT IDNCT00994188

SponsorTokushukai Medical Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

Contact for this trial

Yoshihide Ogawa, MD, PhD

+81-42-500-4433 transplant-office@tokushukai.jp

View on ClinicalTrials.gov More Kidney Neoplasm trials