A Phase 3 interventional study of Everolimus and Tacrolimus in Chronic Kidney Disease, sponsored by Poitiers University Hospital. Completed at 14 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-29.
Sponsored by Poitiers University Hospital · Phase 3, Interventional, and Treatment
Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 329 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Poitiers University Hospital is the lead sponsor of 310 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Tacrolimus (Prograf®) started at 0,1 mg/kg/day since Day0, then adapted to C0 concentration (4-7 ng/ml), * Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml).
Drug: Everolimus · Drug: Tacrolimus
* Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml), * Tacrolimus (Prograg®) started at 0,1 mg/kg/day from J0 then to be adapted to C0 concentration (4-7 ng/ml), then replacement by mycophenolate sodium (Myfortic®) at M3 (3 months visit) started at 1440 mg/day.
Drug: Everolimus · Drug: Mycophenolate sodium
Active Comparator
Also known as: Certican®
Active Comparator
Also known as: Prograg®
Experimental Arm
Also known as: Myfortic®
Renal function as measured by estimated glomerular filtration rate GFR
GFR unit : mL / min / 1.73 m2
Time frame: One year after inclusion
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Poitiers University Hospital