Voclosporin
Phase 2a Kidney Transplantation Study Summary
The Phase 2a renal transplant trial was designed to evaluate voclosporin in stable kidney transplant patients.
| Trial Design: | Open label, randomized trial at 20 centres in Canada and the United States. 12 week study with 67 patients receiving cyclosporine and 65 patients receiving voclosporin. |
| Primary Endpoint: | To demonstrate that stable kidney transplant patients on voclosporin experienced no change in kidney function when compared to patients on cyclosporine. |
| Secondary Endpoint: | To measure the pharmacodynamics of voclosporin in kidney transplant patients. |
| Conclusion: | The trial showed positive results and demonstrated that voclosporin was well tolerated and efficacious. All primary and secondary endpoints of the study were achieved. |
In the Renal Switch trial, voclosporin was compared to cyclosporine A. This graph demonstrates the difference in exposure of the two drugs with almost 3-fold higher cyclosporine blood concentrations compared to voclosporin.
The relationship between drug concentration and its effect on the body can be measured by calcineurin inhibition. Although the blood concentration of voclosporin was three fold less than cyclosporine, the level of inhibition was the same. This confirms the increased potency of voclosporin.
