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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Tokushukai Medical Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tokushukai Medical Group
ClinicalTrials.gov Identifier:
NCT00980317
First received: September 17, 2009
Last updated: October 9, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention
Kidney Neoplasms
Renal Insufficiency
Renal Replacement Therapy
Procedure: Restored Kidney Transplant Between Third Parties

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study of the Living-unrelated Renal Transplantation With Restored Kidneys (Interventional Trial)

Resource links provided by NLM:


Further study details as provided by Tokushukai Medical Group:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: July 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980317

Contacts
Contact: Yoshihide Ogawa, MD, PhD +81-42-500-4433 ext 1305 transplant-office@tokushukai.jp
Contact: Yoshihide Ogawa, MD, PhD +81-42-500-4433 ext 3062 yoshihide.ogawa@tokushukai.jp

Locations
Japan
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    yoshihide.ogawa@tokushukai.jp   
Principal Investigator: Yoshihide Ogawa, MD, PhD         
Sponsors and Collaborators
Tokushukai Medical Group
Investigators
Principal Investigator: Yoshihide Ogawa, MD, PhD Tokyo-West Tokushukai Hospital
  More Information

No publications provided

Responsible Party: Yoshihide Ogawa, Tokyo-West Tokushukai Hospital Transplant Office
ClinicalTrials.gov Identifier: NCT00980317     History of Changes
Other Study ID Numbers: TW062090715KT
Study First Received: September 17, 2009
Last Updated: October 9, 2009
Health Authority: Japan: Institutional Review Board

Keywords provided by Tokushukai Medical Group:
Renal tumor
Restored kidney
Renal transplantation
Third party

Additional relevant MeSH terms:
Neoplasms
Kidney Neoplasms
Renal Insufficiency
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 24, 2014