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Completed

NCT Number: NCT01014234

Rapamycin and Regulatory T Cells in Kidney Transplantation

The immune system response is mediated by the interaction between the antigen presenting cell (APC), CD4+ T helper cells (Th) and CD4+ CD25+ regulatory T cells, a subgroup of CD4+ T cell which express IL-2 receptor (CD25) and the transcriptional factor foxp3. Regulatory T cell may contribute to the maintenance of tolerance by suppressing the immune response to normal or tumor associated antigens.

Regulatory T cell emerge from the thymus during ontogenesis and they represent about 10 % of the peripheral Cd4+ t cells.

Rapamycin is one the most use treatment to prevent renal allograft failure. Differently from calcineurin inhibitors (cyclosporine and tacrolimus), that inhibit T-cell activation through the inhibition of calcineurin activation, rapamycin inhibits cellular proliferation by impairing the progression of the cellular cycle, in particular by interaction with mTOR. Recently Battaglia et al. have demonstrated a Treg amplification in murine CD4+ lymphocytes treated with rapamycin in vitro.

Aim of the study is to evaluate the effect of different immunosuppressive regimens on regulatory T cell and to verify the hypothesis that rapamycin may induce tolerance in kidney transplanted patients, more than cyclosporine treatment.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Policlinico Fondazione IRCCS "San Matteo"

Pavia, 27100, Italy

About this study

It is two years randomised controlled trial in parallel groups.

It has been resolved to compare different immunosuppressive regimens:

  • cyclosporine+ mycophenolate+prednisone
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclosporins

Drug

These patients will undergo maintenance immunosuppressive treatment with cyclosporine + mycophenolate + prednisone according to established clinical practice. The dosage of drugs will be based on evaluations of serum trough levels and it will be adjusted when necessary.

Other names: Neoral

Rapamycin

Drug

These patients will undergo maintenance immunosuppressive treatment with rapamycin + mycophenolate + prednisone according to established clinical practice. The dosage of drugs will be based on evaluations of serum trough levels and it will be adjusted when necessary.

Other names: Sirolimus, Rapamune

Primary outcomes

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

    Time frame: Every 6 months after the transplantation

Secondary outcomes

  1. Adverse events developed during the duration of the clinical study, that damage the patient, that is not part of the natural history of the disease.

    Time frame: Every two months during the follow-up

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Nov 16, 2009
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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