Date: 2015-09-21
Type of information: Publication of results in a medical journal
phase: 3b
Announcement: publication of results in Clinical Transplantation
Company: Veloxis Pharmaceuticals (Denmark)
Product: Envarsus® XR (previously LCP-Tacro™) (tacrolimus)
Action
mechanism: immunosuppressive agent. LCP-Tacro™ is an investigational drug that is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak-to-trough variability when compared to currently approved tacrolimus products.
Disease: prevention of graft rejection in kidney transplantation
Therapeutic area: Transplantation
Country: USA
Trial
details: This is a 2 sequence, open-label, multicenter, prospective Phase 3b clinical study to access drug-induced hand tremors in stable kidney transplant subjects converted from Prograf® (tacrolimus) or generic tacrolimus twice daily (b.i.d.) to LCP-Tacro tablets once daily (q.d.). The trial is designed to determine if the test drug LCP-Tacro, is associated with fewer and/or less severe drug-induced hand tremor than observed with Prograf or generic tacrolimus treatment; each therapy is to be concomitantly administered with mycophenolate mofetil (MMF), mycophenolate sodium (MPS), including generic versions of each, and/or prednisone or equivalent as long as doses remain stable during the study.(NCT01438710)
Latest
news: * On September 21, 2015, Veloxis Pharmaceuticals announced the publication of the Phase IIIb Switching Study of Kidney TRansplant PAtients to LCP-TacrO (STRATO) in Clinical Transplantation. The STRATO study was an open-label, multicenter study demonstrating that kidney transplant patients treated with once-daily Envarsus® XR (formerly known as LCP-Tacro) experienced a reduction in hand tremors following conversion from twice-daily tacrolimus, while maintaining comparable tacrolimus exposure. The results of this study have been presented previously at the 13th American Transplant Congress.
The STRATO study was a 2-sequence, open-label, prospective Phase IIIb, multi-center, clinical study. Kidney transplant patients who were stable on twice-daily tacrolimus and complained of hand tremor were switched to once-daily Envarsus® XR. Tremor was evaluated by independent, blinded neurologists applying the validated Fahn-Tolosa-Marin (FTM) tremor rating scale. In addition, tremor severity was also evaluated by an objective instrument (TremorometerTM), a quality of life questionnaire (QUEST) and a patient assessment of benefit (the Patient Global Impression of Change). Switch from twice-daily tacrolimus to Envarsus® XR resulted in improvement in FTM total score, tremor amplitude as measured by Tremorometer and quality of life [p-values < 0.05]. Both the patient- and physician-reported global assessments demonstrated significant overall improvement following the switch to Envarsus® XR (p<0.0001).* On May 20, 2013, Veloxis Pharmaceuticals has announced that data from the STRATO study demonstrates the potential for LCP-Tacro™ to improve tacrolimus-induced tremors in stable kidney transplant patients. The study, Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO™ (STRATO) clinical trial, was presented at the 13th American Transplant Congress, Abstract #B1022, on Sunday, May 19, 2013 in Seattle."Kidney transplant patients experience multiple side effects from the medicines they are required to take to prevent rejection of their kidneys.In this open-label trial, 44 kidney transplant patients who were stable on twice-daily tacrolimus and had a complaint of hand tremor were switched to once-daily LCP-Tacro™. Tremor was evaluated by independent neurologists using a validated rating scale (the FTM scale) and by an objective measurement of tremor frequency and amplitude by Tremorometer™. In addition, the patients and the clinicians separately assessed global sense of improvement following the switch to LCP-TacroTM.Summary of Results: FTM tremor scalePercent improvement following switch to LCP-TacroTotal score: -15% (p<0.05)Components of scale Tremor severity rating: -5% (p=NS)Motor task performance testing: -9% (p<0.05)Functional impact assessment: -35% (p<0.05)Both the patient- and physician-reported global assessments demonstrated significant overall improvements following the switch to LCP-Tacro™ (p<0.001). Most patients in the study are continuing on a long-term extension phase of the study, receiving LCP-Tacro™.
