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


N/A
20 Years
N/A
Open (Enrolling)
Both
Kidney Neoplasm, Kidney Stone, Ureteral Tumor, Ureteral Stricture, Renal Insufficiency

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Trial Information

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


Inclusion Criteria:



A) 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

B) 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

Exclusion Criteria:

A) 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

B) 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) after renal transplantation with restored kidneys between family members

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:

TW062090617KT

NCT ID:

NCT00994188

Start Date:

July 2009

Completion Date:

June 2014

Related Keywords:

  • Kidney Neoplasm
  • Kidney Stone
  • Ureteral Tumor
  • Ureteral Stricture
  • Renal Insufficiency
  • Renal tumor
  • Ureteral tumor
  • Ureteral stricture
  • Restored kidney
  • Renal transplantation
  • Family members
  • Neoplasms
  • Kidney Calculi
  • Nephrolithiasis
  • Kidney Neoplasms
  • Renal Insufficiency
  • Ureteral Neoplasms
  • Constriction, Pathologic

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