Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mese… (NCT01079143) | Clinical Trial Compass
CompletedPhase 3
Progression of Renal Interstitial Fibrosis / Tubular Atrophy (IF/TA) According to Epithelial-mesenchymal Transition (EMT) and Immunosuppressive Regimen (Everolimus Based Versus CNI Based) in de Novo Renal Transplant Recipients
France194 participantsStarted 2009-09
Plain-language summary
Recently, early biomarkers of renal interstitial fibrosis have been identified, amongst them de novo expression of vimentin by tubular epithelial cells, which is an intermediate filament, and the translocation of beta-catenin into their cytoplasm. These markers, when present, suggest that the epithelial cell undergoes a phenomenon well known as "epithelial to mesenchymal transition" (EMT) and could behaves like a myo-fibroblast. EMT is highly instrumental in several models of tissue fibrosis, including in the kidney. Actually, it has not only been demonstrated that these markers are detectable in the renal graft at an early time point post-transplant (i.e. as soon as three months), but also that the intensity of their expression correlates with the progression of interstitial fibrosis of the graft between 3 and 12 months
Who can participate
Age range19 Years – 75 Years
SexALL
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Inclusion Criteria:
* Recipient of a primary or secondary deceased or living (related or not) donor kidney transplant and who requires basiliximab induction therapy.
* Cold ischemia time \< 30 hours.
* Women of child-bearing age, even those with a history of infertility, must have had a negative pregnancy test during the 7 days before screening or at the time of screening, and must use a recognized and reliable method of contraception throughout the study and for 2 months after discontinuing the study treatment.
* Patients who want and are able to take part in the entire study, and have given their written consent.
* Patients who are registered with a French national health insurance scheme or are covered by such a scheme.
Exclusion Criteria:
* Recipient of multi-organ transplantation, including dual kidneys, or who have previously received non renal transplant organ.
* Patients receiving a graft from a non-heart-beating donor.
* Anti-HLA antibody levels ≥ 20% in the last 3 months before the inclusion.
* ABO incompatible graft or with positive cross match T.
* Severe hyperlipidemia: total cholesterol ≥ 9.1 mmol/L (≥ 350 mg/dL) and/or triglycerides ≥ 8.5 mmol/L (≥ 750 mg/dL) despite appropriate lipid-lowering therapy.
* Known hypersensitivity or contraindications to mycophenolic acid, cyclosporine or lactose.
* Known hypersensitivity or contraindications to macrolides or drugs of the mTOR inhibitor class.
* HIV seropositive, or active chronic hepatitis B (HBs Ab) or C. Resu…
What they're measuring
1
Number of Participants With Progression of Renal Graft Fibrosis (Primary Comparison - ITT Population
Timeframe: Month 3 (M3) and Month 12 (M12) post transplantation