Evaluating Treatments for Adults with Kidney Failure and New Calciphylaxis Ulcers A Multi-Center Study of Dialysis and Drug Therapies

What this Trial Is About

Researchers are evaluating several treatments for adults with kidney failure who have recently been diagnosed with calciphylaxis, a rare disease affecting about 1 to 2 people in 10,000. This phase 3 global platform trial aims to provide high-quality evidence on the effects of different therapies across various care areas. The study uses an adaptive design to add or remove treatment options based on ongoing results, improving how patients with this condition are treated. The trial begins with two main treatment areas the Dialysis Membrane Domain and the Pharmacotherapy Domain. In the Pharmacotherapy Domain, participants receive either Vitamin K1 capsules, Magnesium Citrate tablets, Sodium Thiosulfate injections, or placebos, with dosing schedules matched to their dialysis sessions. The Dialysis Membrane Domain compares two types of dialysis filters, high flux and medium cut-off dialysers, in an open-label design. Treatments are given according to these schedules, and new interventions may be added as the trial progresses. Participants will be monitored and assessed using the BEAT-Calci Wound Assessment Scale over 12 weeks as the primary outcome, with additional evaluations up to 26 weeks and beyond. Assessments include wound measurements, pain levels, analgesic use, quality of life, infection rates, hospital days, mortality, kidney transplantation status, and calciphylaxis recurrence. The study uses a Bayesian adaptive approach to adjust sample size and study arms based on collected data, continuing until clear results on treatment effects are reached.

Better Evidence and Translation for Calciphylaxis