A controlled trial comparing two doses of cyclosporine in conjunction with mycophenolate mofetil and corticosteroids

J Am Soc Nephrol. 2001 Aug;12(8):1750-1757. doi: 10.1681/ASN.V1281750.

Abstract

It is unknown whether the addition of mycophenolate mofetil (MMF) to cyclosporine (CsA) and prednisone after renal transplantation (RTx) allows for a reduced dose of CsA, to minimize the incidence of CsA-related side effects and to reduce costs. Therefore, 313 renal allograft recipients were randomized for treatment with MMF (1000 mg twice a day), prednisone, and either conventional- or low-dose CsA during the first 3 mo after RTx. The target trough levels were 300 and 150 ng/ml, respectively, during the first 3 mo and 150 ng/ml in both groups thereafter. A total of 313 patients were included: 161 patients received a conventional dose and 152 received a low dose of CsA. During the first 6 mo after RTx, graft failure or patient death occurred in 19 of 161 patients (12%) in the conventional-dose group and in 11 of 152 patients (7%) in the low-dose group (not significant). Biopsy-proven acute rejection occurred in 36 of 161 patients (22%) in the conventional-dose group and in 29 of 152 patients (19%) in the low-dose group (not significant). The incidence of delayed graft function was similar in both groups (31 of 161 [19%] versus 28 of 152 [18%]; not significant). Serum creatinine did not differ between the conventional- and the low-dose groups: 151 +/- 56 micromol/L versus 142 +/- 49 micromol/L at 3 mo and 141 +/- 60 micromol/L versus 136 +/- 49 micromol/L at 6 mo. There were no differences between the groups regarding BP, lipid metabolism, and infectious complications. In the low-dose group, an estimated $500 per patient was saved on the costs of CsA. In conclusion, the addition of MMF to CsA and prednisone after RTx allows the use of a lower-than-conventional dose of CsA, without increasing the risk of rejection.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adrenal Cortex Hormones / therapeutic use*
  • Adult
  • Biopsy
  • Blood Pressure
  • Cyclosporine / administration & dosage*
  • Cyclosporine / blood
  • Cyclosporine / economics
  • Cyclosporine / therapeutic use
  • Dose-Response Relationship, Drug
  • Drug Costs
  • Female
  • Graft Rejection / epidemiology
  • Graft Rejection / pathology
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / blood
  • Immunosuppressive Agents / economics
  • Immunosuppressive Agents / therapeutic use
  • Incidence
  • Kidney / physiopathology
  • Kidney Transplantation* / mortality
  • Male
  • Middle Aged
  • Mycophenolic Acid / analogs & derivatives
  • Mycophenolic Acid / therapeutic use*
  • Safety
  • Treatment Failure

Substances

  • Adrenal Cortex Hormones
  • Immunosuppressive Agents
  • Cyclosporine
  • Mycophenolic Acid