Safety of Neoral conversion in maintenance renal transplant patients: A one-year, double-blind study

Daniel C. Brennan, Ralph Barbeito, James Burke, Kenneth Brayman, Stuart M. Greenstein, Tammy Chang

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background. Despite the improved pharmacokinetic characteristics of Neoral, some centers have encountered difficulty with the conversion of some patients from Sandimmune to Neoral and have reported precipitation of toxicity and rejection. Methods. We conducted a randomized, double-blind, parallel-group, multicenter prospective study of stable maintenance renal transplant patients to compare the safety and tolerability of converting from Sandimmune to Neoral (N = 132) versus continuing Sandimmune (N = 130). Patients were studied for one year. The cyclosporine (CsA) dose was adjusted as necessary to maintain site-specific trough whole blood levels. Results. During the study, dose adjustments were frequent in both groups: 67% Neoral versus 65% Sandimmune patients. At study completion, the mean trough CsA levels were comparable; the dose change-from-baseline did not differ statistically between groups. Fewer Neoral (87.1%) than Sandimmune (95.4%) patients reported adverse events, and serious adverse events were comparable. Adverse events related to CsA were not more common in the Neoral group. Renal function measures also implied comparability of the two treatments. Three Neoral versus five Sandimmune patients experienced acute rejection; two Neoral versus five Sandimmune patients experienced chronic graft dysfunction. Two septic deaths occurred in the Neoral group. No grafts were lost. Conclusions. With careful monitoring, conversion of maintenance renal transplant patients to Neoral can be safely accomplished.

Original languageEnglish (US)
Pages (from-to)685-691
Number of pages7
JournalKidney International
Volume56
Issue number2
DOIs
StatePublished - 1999

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Double-Blind Method
Cyclosporine
Maintenance
Transplants
Kidney
Safety
Multicenter Studies

Keywords

  • Cyclosporine A
  • Immunosuppression
  • Nephrotoxicity
  • Transplantation

ASJC Scopus subject areas

  • Nephrology

Cite this

Safety of Neoral conversion in maintenance renal transplant patients : A one-year, double-blind study. / Brennan, Daniel C.; Barbeito, Ralph; Burke, James; Brayman, Kenneth; Greenstein, Stuart M.; Chang, Tammy.

In: Kidney International, Vol. 56, No. 2, 1999, p. 685-691.

Research output: Contribution to journalArticle

Brennan, Daniel C. ; Barbeito, Ralph ; Burke, James ; Brayman, Kenneth ; Greenstein, Stuart M. ; Chang, Tammy. / Safety of Neoral conversion in maintenance renal transplant patients : A one-year, double-blind study. In: Kidney International. 1999 ; Vol. 56, No. 2. pp. 685-691.
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abstract = "Background. Despite the improved pharmacokinetic characteristics of Neoral, some centers have encountered difficulty with the conversion of some patients from Sandimmune to Neoral and have reported precipitation of toxicity and rejection. Methods. We conducted a randomized, double-blind, parallel-group, multicenter prospective study of stable maintenance renal transplant patients to compare the safety and tolerability of converting from Sandimmune to Neoral (N = 132) versus continuing Sandimmune (N = 130). Patients were studied for one year. The cyclosporine (CsA) dose was adjusted as necessary to maintain site-specific trough whole blood levels. Results. During the study, dose adjustments were frequent in both groups: 67{\%} Neoral versus 65{\%} Sandimmune patients. At study completion, the mean trough CsA levels were comparable; the dose change-from-baseline did not differ statistically between groups. Fewer Neoral (87.1{\%}) than Sandimmune (95.4{\%}) patients reported adverse events, and serious adverse events were comparable. Adverse events related to CsA were not more common in the Neoral group. Renal function measures also implied comparability of the two treatments. Three Neoral versus five Sandimmune patients experienced acute rejection; two Neoral versus five Sandimmune patients experienced chronic graft dysfunction. Two septic deaths occurred in the Neoral group. No grafts were lost. Conclusions. With careful monitoring, conversion of maintenance renal transplant patients to Neoral can be safely accomplished.",
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AU - Chang, Tammy

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N2 - Background. Despite the improved pharmacokinetic characteristics of Neoral, some centers have encountered difficulty with the conversion of some patients from Sandimmune to Neoral and have reported precipitation of toxicity and rejection. Methods. We conducted a randomized, double-blind, parallel-group, multicenter prospective study of stable maintenance renal transplant patients to compare the safety and tolerability of converting from Sandimmune to Neoral (N = 132) versus continuing Sandimmune (N = 130). Patients were studied for one year. The cyclosporine (CsA) dose was adjusted as necessary to maintain site-specific trough whole blood levels. Results. During the study, dose adjustments were frequent in both groups: 67% Neoral versus 65% Sandimmune patients. At study completion, the mean trough CsA levels were comparable; the dose change-from-baseline did not differ statistically between groups. Fewer Neoral (87.1%) than Sandimmune (95.4%) patients reported adverse events, and serious adverse events were comparable. Adverse events related to CsA were not more common in the Neoral group. Renal function measures also implied comparability of the two treatments. Three Neoral versus five Sandimmune patients experienced acute rejection; two Neoral versus five Sandimmune patients experienced chronic graft dysfunction. Two septic deaths occurred in the Neoral group. No grafts were lost. Conclusions. With careful monitoring, conversion of maintenance renal transplant patients to Neoral can be safely accomplished.

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