Clinipace to Manage Phase II Trial in Kidney Disease
Therapeutically-Focused Clinical Development Team Leverages Technology-Amplified dCRO Model to Streamline Efficiencies, Reduce Development Costs
Clinipace Worldwide, announced that Phosphate Therapeutics, co-owned and resourced by Shield Therapeutics (Shield), an independent specialty pharmaceutical company, has selected the company to manage its first pivotal trial in its late stage nephrology program expected to commence in 2014.
Clinipace will manage the Phase II trial of PT20, a novel iron-based phosphate binder being developed for the treatment of hyperphosphataemia related to chronic kidney disease (CKD). Hyperphosphataemia is a life-threatening complication of CKD, the incidence of which is increasing globally as obesity and diabetes levels rapidly rise. The treatment of this condition is a significant unmet medical need, which the company states provides it with a strategic opportunity for Phosphate and Clinipace to partner in research.
Read the full release here.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
