Renal Insufficiency Clinical Trial
Official title:
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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