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Effect of Different Therapeutic Strategies on Regulatory T Cells in Kidney Transplantation

NCT01640743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2015-03-25

No results posted yet for this study

Summary

The objective of the study will be to evaluate the effect of different therapeutic immunosuppressive strategies currently employed in common clinical practice on regulatory T lymphocytes and to verify the hypothesis that the association of thymoglobulins - mTOR inhibitors - small doses of Tacrolimus not only represents a safe anti-rejection therapy but it can also lead to mid-term formation of a high amount of regulatory T cells and, consequently, a high grade of tolerance.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Tacrolimus + Methylprednisolone

Induction therapy: Methylprednisolone (500 mg), thymoglobulins (1.5 mg/Kg/die, beginning 1 hour before transplantation) and 1 mg/Kg/die during the following 3 days. Maintenance therapy: Tacrolimus dosage will be 0.2 mg/kg of body weight and will be administered approximately 12 hours after chirurgical intervention twice a day (mornings and evenings). Dosage will be adapted on individual basis in order to gain pre-dose blood dosages according to indicated plasmatic levels

DRUG

Tacrolimus + Everolimus + Methylprednisolone

Induction therapy: Methylprednisolone (500 mg), thymoglobulins (2.5 mg/Kg/die, beginning 1 hour before transplant) and Mycophenolate mofetil (1000 mg) and no immunosuppressive therapy for the following 3 days (WOFIE hypothesis), and for day 4-5-6 thymoglobulins (1.0 mg/Kg/die). Maintenance therapy: Tacrolimus dosage will be 0.1 mg/kg of body weight and will be administered approximately 12 hours after chirurgical intervention twice a day (mornings and evenings). Dosage will be adapted on individual basis in order to gain pre-dose blood dosages according to indicated plasmatic levels

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Principal Investigators

  • Antonio Dal Canton, MD · Nephrology Unit, Fondazione Policlinico "San Matteo", Pavia- Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-06-30
Completion
2014-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640743 on ClinicalTrials.gov