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Status unknownNCT00994188Updated Oct 14, 2009

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

An interventional study of Restored Kidney Transplant Between Family Members in Kidney Neoplasm, Kidney Stone and Ureteral Tumor, sponsored by Tokushukai Medical Group. Status unknown at 2 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2009-10-14.

Sponsored by Tokushukai Medical Group · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Kidney Neoplasm
  • Kidney Stone
  • Ureteral Tumor
  • Ureteral Stricture
  • Renal Insufficiency

Keywords

  • Renal tumor
  • Ureteral tumor
  • Ureteral stricture
  • Restored kidney
  • Renal transplantation
  • Family members
03

In context

Kidney Neoplasms

973 studies on the registry are indexed under Kidney Neoplasms; 214 are open to participants now.

This study's planned enrollment of 5 is below the median of 43 across 664 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Tokushukai Medical Group is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Interventions

  • ProcedureRestored 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

06

What researchers measure

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

    Time frame: 12 Months

07

Study locations

2 of 2 sites recruiting
  • Uwajima Tokushukai Hospital
    Uwajima, Ehime 798-0003, Japan
    • Makoto Mannami, MD · Contact · +81-89-522-2811
    • Makoto Mannami, MD · Principal investigator
    Recruiting
  • Tokyo-West Tokushukai Hospital Transplant Office
    Akishima, Tokyo 196-0003, Japan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00994188
Lead sponsor
Tokushukai Medical Group
First posted
Oct 14, 2009
Start date
Jul 2009
Primary completion
Jun 2014 (estimated)
Completion
Jun 2014 (estimated)
Last update
Oct 14, 2009

Study contacts

Yoshihide Ogawa, MD, PhD
Contact
transplant-office@tokushukai.jp
+81-42-500-4433 ext. 1305
Yoshihide Ogawa, MD, PhD
Contact
yoshihide.ogawa@tokushukai.jp
+81-42-500-4433 ext. 3062
Yoshihide Ogawa, MD, PhD
principal investigator · Tokyo-West Tokushukai Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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