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Published on: July 19, 2019
Randomized controlled trial of FTY720 versus MMF in de novo renal transplantation
Helio Tedesco-Silva1, Mark D Pescovitz, Diane Cibrik
1Setor de Transplante Renal, Hospital do Rim Hipertensão/ UNIFESP, Rua Borges, Lagoa, 960-11o andar, Sao Paulo, SP, Brazil. heliotedesco@hrim.com.br
Background:
Phase II trials of FTY720, a novel immunomodulator, have shown promise in preventing rejection with both standard and reduced cyclosporine exposure. This study was designed to confirm those findings.
Methods:
This one-year, multicenter, randomized, phase III study in 696 de novo renal transplant patients compared FTY720 5 mg plus reduced-dose cyclosporine (RDC) or FTY720 2.5 mg plus full-dose cyclosporine (FDC) with mycophenolate mofetil (MMF) plus FDC. All patients received concomitant corticosteroid therapy without antibody induction. The primary efficacy composite endpoint was the incidence of first treated biopsy-proven acute rejection (treated BPAR), graft loss, death or premature study discontinuation at month 12.
Results:
FTY720 2.5 mg plus FDC was demonstrated to be non-inferior to MMF plus FDC as the primary efficacy endpoint (30.8% and 30.6%) was comparable. The FTY720 5 mg plus RDC treatment regimen was discontinued due to an increased incidence of acute rejection episodes (primary endpoint 43.3%). FTY720 was associated with significantly lower creatinine clearance with a mean difference at 12 months between FTY720 2.5 mg plus FDC and MMF plus FDC of 8 ml/min.
Conclusions:
While FTY720 2.5 mg plus FDC yielded similar efficacy to MMF plus FDC, the FTY720 5 mg plus RDC did not allow a 50% reduction in cyclosporine exposure. The associated lower creatinine clearance indicated that FTY720 combined with cyclosporine provided no benefit over standard care.
Insights
FTY720 (fingolimod) at 2.5 mg with full-dose cyclosporine showed efficacy similar to mycophenolate mofetil. However, higher doses of FTY720 did not reduce cyclosporine needs and lowered kidney function.
Area of Science:
- Nephrology
- Immunology
- Transplantation Medicine
Background:
- Phase II trials suggested FTY720 (fingolimod) efficacy in preventing renal transplant rejection.
- This study aimed to confirm FTY720's effectiveness in de novo renal transplant recipients.
Purpose of the Study:
- To evaluate FTY720 in combination with reduced or full-dose cyclosporine versus mycophenolate mofetil (MMF) plus full-dose cyclosporine.
- To assess FTY720's potential to reduce cyclosporine exposure in renal transplantation.
Main Methods:
- A one-year, multicenter, randomized phase III study involving 696 de novo renal transplant patients.
- Comparison of FTY720 5 mg + reduced-dose cyclosporine (RDC), FTY720 2.5 mg + full-dose cyclosporine (FDC), and MMF + FDC.
- Primary endpoint: incidence of treated acute rejection, graft loss, death, or study discontinuation at 12 months.
Main Results:
- FTY720 2.5 mg + FDC was non-inferior to MMF + FDC (30.8% vs. 30.6% primary endpoint).
- FTY720 5 mg + RDC showed a higher incidence of acute rejection (43.3%) and was discontinued.
- FTY720 use was associated with significantly lower creatinine clearance compared to MMF + FDC.
Conclusions:
- FTY720 2.5 mg + FDC demonstrated comparable efficacy to MMF + FDC in renal transplant patients.
- FTY720 5 mg + RDC did not permit a 50% reduction in cyclosporine exposure.
- The combination of FTY720 and cyclosporine did not offer benefits over standard care due to reduced renal function.
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