Clinical Trials Resource Center

New Medical Therapies™

Kidney Transplantation

Patient Medical Areas

June 9, 2008

Isotechnika reported positive top-line results from a phase IIb trial of voclosporin for the prevention and treatment of kidney transplant rejection. This randomized, multicenter, open-label, concentration controlled, dose ranging study, dubbed PROMISE, enrolled 334 subjects who had recently undergone kidney transplant surgery in the US and Canada. The subjects received three different doses of voclosporin (0.4 mg/kg, 0.6 mg/kg, and 0.8 mg/kg twice daily) or tacrolimus control (0.05 mg/kg twice daily). Voclosporin and tacrolimus were administered over a six month period along with other standard immunosuppressive therapies used following transplantation. The primary endpoint was defined as non-inferiority in biopsy proven acute rejection (BPAR) episodes between the treatment arms. This endpoint was met in all three voclosporin dose groups, showing voclosporin is as efficacious as tacrolimus. In the low dose voclosporin arm, 11% of subjects had BPAR, in the mid-dose arm, 9% had BPAR and in the high dose group 2% had BPAR, compared to 6% of the subjects in the tacrolimus arm. Secondary endpoints, including incidence of new onset diabetes mellitus (NODM), kidney function, electrolytes and neurological effects, were reached as well. A statistically significant lower incidence of NODM was seen in the low dose voclosporin group (1.6%), compared to tacrolimus (16.4%), translating into a 90% reduced risk of developing NODM (p less than 0.05). Although not statistically significant, the mid dose group had a clinically meaningful lower incidence of NODM; the high dose group was not clinically different than tacrolimus. Kidney function was well preserved in each of the three dose levels of voclosporin relative to tacrolimus and no significant differences were noted between the treatment arms. The low dose voclosporin group showed a statistically significant reduction in the number of incidences of elevated triglycerides compared to tacrolimus with a 55% risk reduction (p less than 0.05). The mid and high dose groups showed a 24% to 30% reduced risk of elevated triglycerides. Voclosporin also showed trends to a reduced incidence of insomnia and tremors at the six month time point as compared to tacrolimus. Based on the results Isotechnika plans to move forward with phase III trials.

November 5, 2007

Life Cycle Pharma issued positive interim results from a phase II trial of LCP-Tacro, an immunosuppressant for the prevention of organ transplant rejection in kidney transplant recipients. This three sequence, open-label, multi-center, prospective, conversion study has enrolled 10 stable kidney transplant recipients to date. Once enrolled, the subjects received Prograf, an approved therapy, for seven days. Following a 24-hour pharmacokinetic study on Day seven to determine pharmacokinetics for Prograf, all subjects were converted to once daily LCP-Tacro for seven days with no dose changes allowed. On Day fourteen and Day twenty-one, a 24-hour LCP-Tacro pharmacokinetic study was to be performed. On Day twenty-two, subjects were to be converted back to their original twice daily dose of Prograf for a safety follow-up period of thirty days ending with a safety assessment on Day fifty-two. Interim data showed LCP-Tacro demonstrated a superior profile when compared to Prograf, including better pharmacokinetics, once-a-day tablet formulation and higher bioavailability. Based on the results, the company remains on track to continue with the enrollment of subjects and plans to initiate phase III trials in 2008.

June 9, 2003

Fujisawa Healthcare reported positive results from a post-marketing trial investigating Prograf in combination with Mycophenolate Mofetil (MMF) in pancreas-kidney transplant patients. Results show that subjects receiving induction therapy reported significantly higher kidney survival rate, (92.0%, vs. 81.6%) than those receiving no induction therapy. There was no difference in the pancreas survival rate between the two groups. The 3 year, randomized, multicenter study enrolled 174 subjects and was conducted to assess the effect of antibody induction in SPK transplantation patients receiving maintenance immunosuppression with Prograf, MMF and a steroid taper. Half the subjects received induction therapy and half did not. Results were presented at the 2003 American Transplant Congress.

Isotechnika reported positive results from a phase IIa trial investigating ISA247, an immunosuppressive for the use in kidney transplants. Results showed that all of the primary and secondary endpoints of the study were achieved. Data demonstrated that stable kidney transplant subjects on ISA247 experienced no change in kidney function when compared to subjects taking cyclosporine. In addition, data also demonstrated that ISA247 achieved a level of immunosuppression comparable to cyclosporine at one-third the blood drug concentration. One of the secondary endpoints, the incidence of graft rejection, was designed to monitor safety parameters in kidney transplant patients receiving ISA247. The open label, randomized, multi-center study enrolled 132 subjects at twenty sites in Canada and the United States.

March 18, 2002

Interim phase II trial results indicate that treatment with SangStat's Thymoglobulin results in fewer acute kidney rejections compared to treatment with Novartis' Simulect (basiliximab). Data showed that the incidence of acute kidney rejection was 2.5 times greater for Simulect-treated subjects compared to those who received Thymoglobulin. The randomized comparative trial examined Thymoglobulin versus Simulect as induction therapy in high-risk kidney transplants. There was no statistically significant difference in the rate of severe adverse events between the study arms. An independent Data Safety Monitoring Board has decided to close the study early based on the interim analysis.

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