Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-fre… (NCT01595984) | Clinical Trial Compass
UnknownPhase 3
Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)
France90 participantsStarted 2012-05-03
Plain-language summary
The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.
Renal function will be accurately evaluated by measuring the clearance of iohexol.
The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Males and Females aged between 18 and 70.
* Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated.
* Patient with a maximum PRA \<20%.
* Patient wishing and being able to participate fully to the study, and having given a written consent.
* Patient covered by a social insurance or beneficiary of such a regime.
* Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment.
Exclusion Criteria:
* Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match.
* Patient with a maximum PRA\> 20% twice.
* Cold ischemic time \> 36 hours.
* Patients with thrombocytopenia (\<75000/mm3), neutropenia (\<1 500 / mm3), leukopenia (\<2 500 / mm3) or a hemoglobin concentration \<8 g / dl, at inclusion visit.
* Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy.
* Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded.
* Patient with severe systemic infections requiring continued therapy.
* Treatment with an experimental drug within 4 weeks before the first dose of study treatment.
* Patient for whom the initial dis…
What they're measuring
1
Evolution of glomerular filtration rate measured by clearance of iohexol