A Phase 4 interventional study of Anti-thymocyte globulin and Mycophenolate mofetil in Kidney Diseases, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-12-08.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
This study was done to find out which treatment, tacrolimus or sirolimus, leads to better long-term kidney function in kidney transplant patients.
The aim of this study was to compare the complete avoidance of calcineurin inhibitors (CI) using a sirolimus-based immunosuppressive regimen to a tacrolimus-based regimen in kidney transplantation. This study was a prospective open-label trial randomizing patients to receive tacrolimus, mycophenolate mofetil and prednisone or sirolimus, mycophenolate mofetil and prednisone. All patients received antithymocyte globulin induction. All rejection episodes were proven by biopsy. The hypothesis was that CI free immunosuppression after kidney transplantation will lead to an increase in glomerular filtration rate (GFR) at one year after kidney transplantation.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 165 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Calcineurin inhibitor arm, consisting of treatment with tacrolimus, mycophenolate mofetil, and prednisone.
Drug: Anti-thymocyte globulin · Drug: Mycophenolate mofetil · Drug: Prednisone · Drug: Tacrolimus
Calcineurin inhibitor-free arm, consisting of treatment with rapamycin, mycophenolate mofetil, and prednisone.
Drug: Anti-thymocyte globulin · Drug: Mycophenolate mofetil · Drug: Prednisone · Drug: Sirolimus
Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
Also known as: Thymoglobulin, Atgam
Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
Also known as: CellCept
Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
Also known as: Deltasone, Liquid Pred, Meticorten, Orasone, Prednicen-M, Prednicot, Sterapred, Sterapred DS
Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)
Also known as: Prograf, Advagraf, Protopic
Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml
Also known as: Rapamune
Glomerular filtration rate (GFR) (iothalamate clearance) at 12 months following transplantation
Glomerular filtration rate (Iothalamate clearance) at 12 months following transplantation.
Time frame: 12 months following transplantation
GFR (iothalamate clearance) at other time points
Time frame: 24 months
Other measures of renal function (serum creatinine, proteinuria and albuminuria)
Time frame: 24 months
Acute rejection both early and after tacrolimus withdrawal
Time frame: 24 months
Patient and graft survival
Time frame: 24 months after transplantation
Complications-especially hypertension, diabetes, dyslipidemia
Time frame: 24 months
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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