Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients: a multicenter study.
This 24-week, open, single-arm, prospective, multicenter study evaluated the effects of conversion from ciclosporin to Tacrolimus QD in adult kidney transplant patients. Stable patients receiving ciclosporin were converted to Tacrolimus QD at 0.1mg/kg/day. Relative change in renal function (primary endpoint) was assessed using estimated creatinine clearance (eCrCl) with a noninferiority margin set at -10%. A total of 346 patients were enrolled; and 301 patients were treated per protocol (PPS) in the hyperlipidemia (n=42), hypertrichosis (n=106), hypertension (n=77) and gingival hyperplasia (n=76) groups. Relative change in eCrCl was -0.6% in all PPS patients (95% CI, -2.2; 0.9) and -5.3% in the hyperlipidemia (CI, -9.59; -0.97), 0.9% in the hypertrichosis (CI, -2.59; 4.45), -0.1% in the hypertension (CI, -3.8; 3.68), and -1% in the gingival hyperplasia groups (CI, -4.63; 2.65) (PPS), meeting noninferiority criteria. There was no acute rejection. Decreases in serum lipids and blood pressure were moderate but without meaningful change in the number of treatment medications. Substantial decreases in severity of ciclosporin-related cosmetic side effects were evident from investigator and patient self-report of symptoms. Renal function remained stable after conversion to Tacrolimus QD. The effect of conversion on cardiovascular parameters was not clinically meaningful, however, marked improvement in ciclosporin-related cosmetic side effects was observed. (ClinicalTrials.gov number: NCT00481481).
Hopital de Rangueil, Nephrology, Dialysis and Organ Transplant Unit, Toulouse, France. rostaing.l@chu-toulouse.fr
Lionel
L
Rostaing
Ana
A
Sánchez-Fructuoso
Antonio
A
Franco
Maciej
M
Glyda
Dirk R
DR
Kuypers
Jenö
J
Jaray
D000328:Adult; D000368:Aged; D003404:Creatinine / Q000097:blood; D016572:Cyclosporine / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D005885:Gingival Hyperplasia / Q000139:chemically induced* / Q000188:drug therapy; D006801:Humans; D006949:Hyperlipidemias / Q000139:chemically induced / Q000188:drug therapy; D006973:Hypertension / Q000139:chemically induced / Q000188:drug therapy; D006983:Hypertrichosis / Q000139:chemically induced* / Q000188:drug therapy; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000502:physiology*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016559:Tacrolimus / Q000097:blood / Q000627:therapeutic use*
D007166:Immunosuppressive Agents; D008055:Lipids; D016572:Cyclosporine; D003404:Creatinine; D016559:Tacrolimus