13 research outputs found

    The Grizzly, September 9, 2010

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    Phi Kappa Sigma Wins Ultimate Honor • Berman Museum Celebrates Opening of Pfeiffer Wing • Board of Trustees Continues Search for New President • Campus Activities Board Gets the Party Started with a Little Foam • Insider\u27s View to Avoiding the Dreaded Freshman 15 • Living Your Truth with Jenny Boylan • Opinions: Opting Out of Greek Life at Ursinus; Going Greek Without any Regrets; New Wismer Brings Mixed Feelings • UC Women\u27s Soccer Off to Strong Start within Conference • Football Takes Season One Game at a Timehttps://digitalcommons.ursinus.edu/grizzlynews/1816/thumbnail.jp

    The Grizzly, September 23, 2010

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    Biology Department Receives $1.3 Million Grant • Shorter Rush Period Impacts Thoughts Surrounding Greeks • Students Continue the Growth of the UC Organic Garden • Lecture on Protecting Manatees Highlights Human Interference • How to Become a Deep Learner • Project Pericles to Sponsor Debating for Democracy in the Berman Museum Tomorrow • Bed Bug Epidemic Hits College Campuses Across Nation • Professor Seeking Tenure: Dr. Rebecca Jaroff • Opinions: Catholic Church Taking the Next Step Towards Healing; Never-Ending Ordeal of Crossing Main Street • UC Alum Honored with Prestigious Gymnastics Accolade • UC Field Hockey: In it to Win it for \u2710 Seasonhttps://digitalcommons.ursinus.edu/grizzlynews/1818/thumbnail.jp

    User Experience (UX): Successful Remote Engagement Strategy for Individuals at Risk for Parkinson's Disease in PPMI

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    Digital instruments continue to gain footing in clinical trials as enhancements to in-clinic engagement. However, few studies focus on how remote engagement can be associated with high rates of attrition due to various aspects of the UX. The study design for the Parkinson’s Progression Markers Initiative (PPMI) Smell Test (ST) Direct screening structure, initiated in mid-2022, incorporates practices within the web-based portal that help to sustain progressive UX and facilitate study compliance. Olfactory dysfunction is a key risk factor for the typical symptoms of PD. Strategic use of technology enables the study to guide participants through a multi-step digital process

    From O’Shaughnessy to opportunity: innovating Hepatology Trials in the UK

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    Developing new treatments that improve outcomes for patients with decompensated cirrhosis remains an unmet area of clinical need. The UK has a rich history of being on the forefront of clinical trials for this patient group. However, there have been challenges in achieving this goal in the past decade, with several negative studies as well as trials struggling to achieve recruitment. This has been further exacerbated by the changed clinical landscape following the COVID-19 pandemic. In response to this, the O’Shaughnessy report was commissioned to identify potential opportunities to improve clinical trial performance in the UK. In this review article, we identify critical areas for the UK hepatology community to collaborate and develop sustainable partnerships for clinical trial delivery which will ensure that outcomes are representative, inclusive and patient-centred

    Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

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    Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics

    Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial

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    Background Sparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis. Methods PROTECT, a double-blind, randomised, active-controlled, phase 3 study, was done across 134 clinical practice sites in 18 countries throughout the Americas, Asia, and Europe. Patients aged 18 years or older with biopsy-proven primary IgA nephropathy and proteinuria of at least 1·0 g per day despite maximised renin–angiotensin system inhibition for at least 12 weeks were randomly assigned (1:1) to receive sparsentan (target dose 400 mg oral sparsentan once daily) or irbesartan (target dose 300 mg oral irbesartan once daily) based on a permuted-block randomisation method. The primary endpoint was proteinuria change between treatment groups at 36 weeks. Secondary endpoints included rate of change (slope) of the estimated glomerular filtration rate (eGFR), changes in proteinuria, a composite of kidney failure (confirmed 40% eGFR reduction, end-stage kidney disease, or all-cause mortality), and safety and tolerability up to 110 weeks from randomisation. Secondary efficacy outcomes were assessed in the full analysis set and safety was assessed in the safety set, both of which were defined as all patients who were randomly assigned and received at least one dose of randomly assigned study drug. This trial is registered with ClinicalTrials.gov, NCT03762850. Findings Between Dec 20, 2018, and May 26, 2021, 203 patients were randomly assigned to the sparsentan group and 203 to the irbesartan group. One patient from each group did not receive the study drug and was excluded from the efficacy and safety analyses (282 [70%] of 404 included patients were male and 272 [67%] were White) . Patients in the sparsentan group had a slower rate of eGFR decline than those in the irbesartan group. eGFR chronic 2-year slope (weeks 6–110) was −2·7 mL/min per 1·73 m2 per year versus −3·8 mL/min per 1·73 m2 per year (difference 1·1 mL/min per 1·73 m2 per year, 95% CI 0·1 to 2·1; p=0·037); total 2-year slope (day 1–week 110) was −2·9 mL/min per 1·73 m2 per year versus −3·9 mL/min per 1·73 m2 per year (difference 1·0 mL/min per 1·73 m2 per year, 95% CI −0·03 to 1·94; p=0·058). The significant reduction in proteinuria at 36 weeks with sparsentan was maintained throughout the study period; at 110 weeks, proteinuria, as determined by the change from baseline in urine protein-to-creatinine ratio, was 40% lower in the sparsentan group than in the irbesartan group (−42·8%, 95% CI −49·8 to −35·0, with sparsentan versus −4·4%, −15·8 to 8·7, with irbesartan; geometric least-squares mean ratio 0·60, 95% CI 0·50 to 0·72). The composite kidney failure endpoint was reached by 18 (9%) of 202 patients in the sparsentan group versus 26 (13%) of 202 patients in the irbesartan group (relative risk 0·7, 95% CI 0·4 to 1·2). Treatment-emergent adverse events were well balanced between sparsentan and irbesartan, with no new safety signals. Interpretation Over 110 weeks, treatment with sparsentan versus maximally titrated irbesartan in patients with IgA nephropathy resulted in significant reductions in proteinuria and preservation of kidney function.</p
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