NCT06225544

Lumasiran in Hyperoxalaemic Patients on Haemodialysis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will look at how well a drug that reduced the amount of oxalate in the body works in patients that have kidney disease and need dialysis treatment. People with kidney disease often have higher levels of oxalate in the blood. People with kidney disease are also at higher risk of having heart attacks, heart disease and strokes (these are called cardiovascular diseases). It is thought that high oxalate levels may increase the risk of these diseases. This study will investigate if this medicine can lower the amount of oxalate in the blood of dialysis patients and see if there is any change in the health of their heart. This medicine is already used for people who have high oxalate levels because of a genetic cause and has been used safely for patients on dialysis. The study will put the participants randomly into either the group getting the study medicine or the group getting a placebo (this will be a solution of saline water). Neither participants not the doctors will know whether the drug or placebo is given until after the end of the study. At the start of the study all the participants will have an echocardiogram (an ultrasound of the heart) and again 6 months later at the end of the study. We will also take blood tests once a month when the participants come for dialysis.

Detailed description

This is an investigator-initiated, double-blind, phase II two-centre medications study with an intervention and placebo arm. The principal objective of this study is to establish if the administration of lumasiran versus placebo can effectively lower pre-dialysis oxalate levels in hyperoxalaemic haemodialysis patients with any cause of ESKD (end stage kidney disease) except known primary hyperoxaluria. The hypothesis is that compared to placebo, the administration of lumasiran (the study drug) will reduce serum oxalate levels at 3-6 months post first dose in hyperoxalaemic haemodialysis patients. This study will evaluate the use of lumasiran in haemodialysis patients. Lumasiran will be dosed as per the SmPC published by the European Medicines Agency. Monthly pre-dialysis plasma oxalate measurements will be taken to assess the effect of lumasiran on lowering the oxalate levels versus a placebo. Thus far studies have shown lumasiran to be well tolerated. The tolerability in this patient cohort will be evaluated and monitor inflammatory and cardiovascular biomarkers in addition to cardiac imaging with echocardiograms.

Conditions

• Haemodialysis
• Chronic Kidney Disease Requiring Chronic Dialysis
• Cardiovascular Disease
• Cardiovascular Risk Factor
• Hyperoxalemia

Interventions

Type	Name	Description
DRUG	Lumasiran	Subcutaneous injection, given as three monthly loading doses followed by one further maintenance dose.
DRUG	0.9% Sodium Chloride (placebo)	Placebo, subcutaneous injection, given as three monthly loading doses followed by one further maintenance dose.

Timeline

• Start date: 2024-04-14
• Primary completion: 2025-01-30
• Completion: 2025-03-01
• First posted: 2024-01-26
• Last updated: 2024-08-21

Locations

1 site across 1 country: Germany