Sodium Mycophenolate/Everolimus Regimen Effective After Calcineurin Inhibitor Withdrawal in Renal Transplant Patients: Presented at TTS

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Title: Sodium Mycophenolate/Everolimus Regimen Effective After Calcineurin Inhibitor Withdrawal in Renal Transplant Patients: Presented at TTS
URL: http://www.pslgroup.com/dg/228382.htm
Doctor's Guide
August 12, 2008

By Rachel Parratt

SYDNEY, Australia -- August 12, 2008 -- Data from the first 287 de novo renal transplant patients in the ZEUS study showed significant improvement in renal function after calcineurin inhibitor withdrawal, without compromised efficacy and safety.

Klemens Budde, MD, Clinical Transplant Program, Department of Nephrology, Charite Universitatismedizin, Berlin, Germany, presented the findings here at on August 12 at the 22nd International Congress of the Transplantation Society (TTS 2008).

The 12-month, randomised, open-label, controlled, multicentre study compared the efficacy, safety, and tolerability of an immunosuppressive regimen with everolimus and enteric-coated mycophenolate sodium (EC-MPS [Myfortic]) to that of cyclosporine (CsA) and EC-MPS in 300 renal allograft recipients.

After induction therapy with basiliximab (Simulect), all patients received CsA, EC-MPS, and corticosteroids for the first 4.5 months post-transplant. Corticosteroids were prescribed according to centre practice with a minimum dose of 5 mg QD.

Subsequently patients were randomised to either continue the current regimen of CsA and EC-MPS 720 mg BID (n = 150) or convert from CsA to everolimus over a 4-week period and continue on with everolimus and EC-MPS 720 mg BID (n = 150).

The primary endpoint was renal function at 12 months, determined by glomerular filtration rate (GFR), calculated by the Nankivell method. Additional renal endpoints included GFR calculated according to Cockcroft-Gault and Modification of Diet in Renal Disease (MDRD) method, serum creatinine, and slope of creatinine.

There was a significant difference in the primary endpoint between the everolimus-treated group (n = 147) compared with the CsA-treated group (n = 140). Calculated GFRs were 72.3 versus 62.2 mL/min/1.73 m² (P < .001).

The secondary endpoint of GFR, calculated by Cockcroft-Gault method was also statistically significant between the 2 groups (P < .0001).

There were no significant differences in treatment failure, death, loss to follow-up, biopsy proven acute rejection (BPAR), or time to BPAR between groups. Haematological safety parameters and lipid profiles were also similar between groups.

In the everolimus-treated group, incidence of diarrhoea (36%) and constipation (52%) was higher than in the CsA-treated group (28%, 49%).

Dr. Budde commented that "the ZEUS regimen reflects a therapeutic approach of maintaining stable renal function after calcineurin inhibitor withdrawal, without compromising efficacy and safety."

Funding for this study was provided by Novartis.

[Presentation title: Renal Function, Efficacy and Safety of Everolimus (RAD)/Enteric-Coated Mycophenolate Sodium (EC-MPS) Therapy After Calcineurin Inhibitor (CNI) Withdrawal in De Novo Renal Transplant Patients: Final Outcomes of the ZEUS Study. Late Breaking Oral Session 21 TO21]

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