A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Third Parties

Renal Insufficiency Clinical Trial

Official title:

A Clinical Study of the Living-unrelated Renal Transplantation With Restored Kidneys (Interventional Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00980317
• Other study ID #: TW062090715KT
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2009
• Last updated: October 9, 2009
• Start date: July 2009
• Est. completion date: June 2014

Study information

• Verified date: October 2009
• Source: Tokushukai Medical Group
• Contact: Yoshihide Ogawa, MD, PhD
• Phone: +81-42-500-4433
• Email: transplant-office[@]tokushukai.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 to 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 come back 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 renal transplantations between non-relatives (third parties) are currently not 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 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 occurence of renal cancer) of living renal transplantations between third parties (non-relatives) with restored donor kidneys after the surgical removal of a small size (4 cm or less) renal tumor, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Recipient:

• Patients who are on dialysis and are willing to receive a restored kidney from a third party

• Patients who are eligible for general anesthesia

• Patients who have given written informed consent to participate in the study

2. Donor:

• Patients who have small tumor (size: <4 cm) in the kidney and have chosen total nephrectomy among all the available treatment options and have permitted to transplant the nephrectomized kidney to a third party 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:

1. 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

2. 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Insufficiency
• Renal Replacement Therapy

Intervention

Procedure:
• Restored Kidney Transplant Between Third Parties
Tumor part of the donor kidney is surgically removed and the kidney is restored and transplanted to a third party recipient

Locations

Country	Name	City	State
Japan	Tokyo-West Tokushukai Hospital Transplant Office	Akishima City	Tokyo
Japan	Uwajima Tokushukai Hospital	Uwajima	Ehime

Sponsors (1)

Lead Sponsor	Collaborator
Tokushukai Medical Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of curative efficacy (renal function and QOL) and safety (side effects, complications or occurence of renal cancer) after renal transplantation with restored donor kidneys to third party recipients		12 Months	Yes