Lumasiran in Hyperoxalaemic Patients on Haemodialysis — LHOxH  

Cardiovascular Disease Clinical Trial

Official title: Lumasiran in Hyperoxalaemic Patients on Haemodialysis

Status Not yet recruiting

Clinical Trial 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. So we would like to study 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 we will ask all the participants to 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.

Clinical Trial 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.

Our 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. We will evaluate tolerability in this patient cohort and monitor inflammatory and cardiovascular biomarkers in addition to cardiac imaging with echocardiograms. ;

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Chronic Kidney Disease Requiring Chronic Dialysis
• Haemodialysis
• Hyperoxalemia
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT06225544
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Contact: Gerlineke MC Hawkins-van der Cingel, MBBS
• Phone: + 49 030 450 530067
• Email: gerlineke.hawkins-van-der-cingel@charite.de
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2024
• Completion date: January 15, 2025