A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Family Members
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|ClinicalTrials.gov Identifier: NCT00994188|
Recruitment Status : Unknown
Verified October 2009 by Tokushukai Medical Group.
Recruitment status was: Recruiting
First Posted : October 14, 2009
Last Update Posted : October 14, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Neoplasm Kidney Stone Ureteral Tumor Ureteral Stricture Renal Insufficiency||Procedure: Restored Kidney Transplant Between Family Members||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Study of the Living-related Renal Transplantation With Restored Kidneys (Interventional Trial)|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2014|
- Procedure: Restored Kidney Transplant Between Family Members
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994188
|Contact: Yoshihide Ogawa, MD, PhD||+81-42-500-4433 ext firstname.lastname@example.org|
|Contact: Yoshihide Ogawa, MD, PhD||+81-42-500-4433 ext email@example.com|
|Uwajima Tokushukai Hospital||Recruiting|
|Uwajima, Ehime, Japan, 798-0003|
|Contact: Makoto Mannami, MD +81-89-522-2811|
|Principal Investigator: Makoto Mannami, MD|
|Tokyo-West Tokushukai Hospital Transplant Office||Recruiting|
|Akishima City, Tokyo, Japan, 196-0003|
|Contact: Yoshihide Ogawa, MD, PhD +81-42-500-4433 ext 1305 firstname.lastname@example.org|
|Principal Investigator: Yoshihide Ogawa, MD, PhD|
|Principal Investigator:||Yoshihide Ogawa, MD, PhD||Tokyo-West Tokushukai Hospital|