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


N/A
20 Years
N/A
Open (Enrolling)
Both
Kidney Neoplasms, Renal Insufficiency, Renal Replacement Therapy

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

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

Outcome Time Frame:

12 Months

Safety Issue:

Yes

Principal Investigator

Yoshihide Ogawa, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tokyo-West Tokushukai Hospital

Authority:

Japan: Institutional Review Board

Study ID:

TW062090715KT

NCT ID:

NCT00980317

Start Date:

July 2009

Completion Date:

June 2014

Related Keywords:

  • Kidney Neoplasms
  • Renal Insufficiency
  • Renal Replacement Therapy
  • Renal tumor
  • Restored kidney
  • Renal transplantation
  • Third party
  • Neoplasms
  • Kidney Neoplasms
  • Renal Insufficiency

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