Study of Lumasiran to Lower Oxalate Levels in Adults on Haemodialysis with Kidney Disease Phase 2, Double-Blind, Randomized Trial Comparing Lumasiran to Placebo

What this Trial Is About

This research aims to evaluate a drug called lumasiran in patients with kidney disease who require haemodialysis and have high levels of oxalate in their blood. People with kidney disease often face higher risks of heart attacks, heart disease, and strokes, possibly linked to elevated oxalate levels. The study will investigate whether lumasiran can reduce oxalate levels in these patients and monitor any changes in their heart health using echocardiograms. Participants will be randomly assigned to receive either lumasiran or a placebo, both given as subcutaneous injections with three monthly loading doses followed by one maintenance dose. The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given until the study concludes. Monthly blood tests will measure pre-dialysis plasma oxalate levels, and echocardiograms will be performed at the start and after six months. During the study, participants will attend monthly visits for blood tests alongside their dialysis sessions, and heart ultrasounds will be done at baseline and six months to assess cardiac changes. Researchers will monitor oxalate levels, side effects, inflammatory and cardiovascular biomarkers, and overall tolerability of lumasiran. The study duration is six months, with data collected regularly to evaluate the drugs impact on oxalate reduction and heart health.

Lumasiran in Hyperoxalaemic Patients on Haemodialysis