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Kidney NeoplasmsNCT00980317

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

A study testing Restored Kidney Transplant Between Third Parties in people with Kidney Neoplasms and Renal Insufficiency, run by Tokushukai Medical Group at 2 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Restored Kidney Transplant Between Third Parties
Type of treatment
Surgery or procedure
How many people
5 participants
Where
2 sitesJapan
Study dates
Jul 2009to Jun 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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

Who cannot join

  • 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
  • Donor:
  • Patients who have tested positive for serious infectious disease (eg. HIV, HBV, or HCV)
Show all 10Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Yoshihide Ogawa, MD, PhD contact

+81-42-500-4433 ext. 1305

transplant-office@tokushukai.jp

Yoshihide Ogawa, MD, PhD contact

+81-42-500-4433 ext. 3062

yoshihide.ogawa@tokushukai.jp

Japan2 sites, 2 recruiting

  • Tokyo-West Tokushukai Hospital Transplant Office

    Akishima, Tokyo, 196-0003

    Yoshihide Ogawa, MD, PhD, +81-42-500-4433 ext. 1305, yoshihide.ogawa@tokushukai.jp

    Yoshihide Ogawa, MD, PhD

    Recruiting

  • Uwajima Tokushukai Hospital

    Uwajima, Ehime, 798-0003

    Makoto Mannami, MD, +81-89-522-2811

    Makoto Mannami, MD

    Recruiting

Other trials in Japan

About this study

Official title: A Clinical Study of the Living-unrelated 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 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.

Read more

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.

Being tested
Restored Kidney Transplant Between Third Parties
Keywords
Renal tumor, Restored kidney, Renal transplantation, Third party
Medical subject headings
Kidney Neoplasms, Renal Insufficiency, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Restored Kidney Transplant Between Third PartiesProcedure or surgery

    Tumor part of the donor kidney is surgically removed and the kidney is restored and transplanted to a third party recipient

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2014 (estimated)
  4. Study completionJun 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00980317
Sponsor's protocol ID
TW062090715KT
Status last verified
Oct 2009
First submitted
17 Sep 2009
Last updated
14 Oct 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Restored Kidney Transplant Between Third Parties in people with Kidney Neoplasms and Renal Insufficiency, run by Tokushukai Medical Group at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yoshihide Ogawa, MD, PhD (+81-42-500-4433 ext. 1305, transplant-office@tokushukai.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00980317.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2009.

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