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Rapamycin and Regulatory T Cells in Renal Transplant Patients: a Two-year Randomized Prospective Study

Phase 2
18 Years
75 Years
Open (Enrolling)
Kidney Transplantation

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Trial Information

Rapamycin and Regulatory T Cells in Renal Transplant Patients: a Two-year Randomized Prospective Study

It is two years randomised controlled trial in parallel groups.

It has been resolved to compare different immunosuppressive regimens:

1. cyclosporine+ mycophenolate+prednisone

2. rapamycin + mycophenolate + prednisone, this treatment should be introduced after one
month from renal transplantation.

Patient should visited at month 1-6-12-24 from the transplant. During the control we will
reported the following data: physical examination, blood test (blood count, creatinin, BUN,
immunosuppressive blood concentration, histological response of surveillance renal biopsy),
blood pressure, attendant change of current therapy, pathological variation, or any
hospitalisation both ordinary or in DH regimen.

Moreover in all control visit it will be collected a blood sample for evaluation of
regulatory t cells.

Inclusion Criteria:

- Male and female aged from 18 to 75 years

- Transplanted patients from cadaveric donors

- Patients who has given written informed consensus

Exclusion Criteria:

- Legally unable patients

- Patients who have been participated to others studies in the last 3 months

- Addicted to alcohol or smoking

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The absolute number of T-reg after renal transplant in patients in treatment with rapamycin compared to patients treated with cyclosporine

Outcome Time Frame:

Every 6 months after the transplantation

Safety Issue:


Principal Investigator

Antonio Dal Canton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Policlinico Fondazione IRCCS "San Matteo", Pavia


Italy: Ethics Committee

Study ID:




Start Date:

July 2008

Completion Date:

March 2013

Related Keywords:

  • Kidney Transplantation
  • Immunosuppressive Agents
  • Immune system regulation
  • Regulatory T cells
  • Rapamycin
  • Tolerance