Results of a three-year prospective study of C2 monitoring in long-term renal transplant recipients receiving cyclosporine microemulsion.

BACKGROUND

The clinical utility of C(2) monitoring of cyclosporine A microemulsion (CsA-ME) was evaluated in a prospective study of 110 patients more than 12 months posttransplant who demonstrated stable graft function and were receiving CsA-ME and steroids.

METHODS

Patients were converted to C(2) monitoring with the CsA-ME dose adjusted to a target C(2) range of 800 to 1,000 ng/mL and followed for 40 + 11 months.

RESULTS

At the time of conversion, 57% of patients exceeded the C(2) target, 20% of patients were below the C(2) target, and 23% of patients were within the C(2) target range. The mean dose of CsA-ME decreased from 258 + 88 to 202 + 76 mg/day (P < 0.0001), and the mean C(2) level decreased from 1,052 + 292 ng/mL to 896 + 233 ng/mL (P < 0.0002). There were no episodes of rejection. At last follow-up, 7.3% of patients had developed chronic renal allograft dysfunction. Use of antihypertensive agents decreased significantly (P = 0.0004), and mean total cholesterol decreased from 6.4 + 1.3 to 5.8 + 1.1 (P = 0.0009) after adoption of C(2) monitoring.

CONCLUSION

These findings suggest that conversion of maintenance renal transplant recipients from C(0) to C(2) monitoring of CsA-ME offers the clinical benefits of better control of hypertension and dyslipidemia, with effective protection against chronic renal allograft dysfunction. A target C(2) range of 800 to 1,000 ng/mL in maintenance patients receiving CsA-ME dual therapy seems appropriate.