Kidney NeoplasmNCT00994188
A Clinical Study of the Living Renal Transplantation With Restored Kidneys Between Family Members
A study testing Restored Kidney Transplant Between Family Members in people with Kidney Neoplasm and Kidney Stone, run by Tokushukai Medical Group at 2 sites in Japan.
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 with 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
- Conditions the study is for
- Kidney Neoplasm, Kidney Stone, Ureteral Tumor
- What is being tested?
- Restored Kidney Transplant Between Family Members
- 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 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
- 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
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.
Japan2 sites, 2 recruiting
- 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
About this study
Official title: A Clinical Study of the Living-related 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 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.
Read more
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.
- Being tested
- Restored Kidney Transplant Between Family Members
- Keywords
- Renal tumor, Ureteral tumor, Ureteral stricture, Restored kidney, Renal transplantation, Family members
- Medical subject headings
- Kidney Neoplasms, Kidney Calculi, Ureteral 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 Family MembersProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of curative efficacy (renal function and QOL) and safety (side effects, complications) after renal transplantation with restored kidneys between family members
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tokushukai Medical Group
- Sponsor type
- University, hospital or other
- Investigators
- Yoshihide Ogawa, MD, PhD, Principal investigator, Tokyo-West Tokushukai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00994188
- Sponsor's protocol ID
- TW062090617KT
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2009
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Living-related Renal Transplantation With Restored Kidneys (Interventional Trial)
- ClinicalTrials.gov ID
- NCT00994188
- Acronym / sponsor ID
- TW062090617KT
- Keywords
- Renal tumor, Ureteral tumor, Ureteral stricture, Restored kidney, Renal transplantation, Family members
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Tokushukai Medical GroupUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 14 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Donor:
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restored Kidney Transplant Between Family MembersTumor 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 | Procedure or surgery | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshihide Ogawa, MD, PhD principal investigator
Tokyo-West Tokushukai Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restored Kidney Transplant Between Family Members in people with Kidney Neoplasm and Kidney Stone, 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) after renal transplantation with restored kidneys between family members (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.