A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Family Members
1 other identifier
interventional
5
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 9, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedOctober 14, 2009
October 1, 2009
4.9 years
October 9, 2009
October 13, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of curative efficacy (renal function and QOL) and safety (side effects, complications) after renal transplantation with restored kidneys between family members
12 Months
Interventions
Tumor part of the kidney or ureter and ureteral stricture is surgically removed or repaired and the kidney is restored and transplanted to a family member recipient
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Uwajima Tokushukai Hospital
Uwajima, Ehime, 798-0003, Japan
Tokyo-West Tokushukai Hospital Transplant Office
Akishima, Tokyo, 196-0003, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoshihide Ogawa, MD, PhD
Tokyo-West Tokushukai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 9, 2009
First Posted
October 14, 2009
Study Start
July 1, 2009
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
October 14, 2009
Record last verified: 2009-10