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Lumasiran in Hyperoxalaemic Patients on Haemodialysis

Study acronym: LHOxH
StatusUnknown
PhasePhase 2
Started2024-04-14
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 21, 2024 (before its estimated January 30, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
Trial status changed: Recruiting → Unknown
2024-08-19
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Unknown
Primary completion date2024-11-30→2025-01-30
Completion date2025-01-15→2025-03-01
Start dateestimated 2024-03-01→confirmed 2024-04-14
Study sites0→1
InterventionsLumasiran (Drug)→0.9% Sodium Chloride (placebo) (Drug), Lumasiran (Drug)
Eligibility criteria-601 characters
[...] rmanent dialysis catheter/tunnelled haemodialysis line (THL). ESKD not caused by previously diagnosed primary hyperoxaluri [...] haemodialysis for less than 2 months. On peritoneal dialysis. Combined haemodialysis and peritoneal dialysis. Temporary or poorly functioning haemodialysis access (see Section 5c for further definition) Pregnancy, planning pregnancy or currently breast feeding. [...] me, or a malabsorptive disorder. Decompensated Liver failure. Intercurrent active infection and/or antibiotic treatment. Currently on Vitamin C treatment with a daily dose of more than 250mg. Terminal illness and/or [...] [...]
Study description+5 characters
[...] d stage kidney disease) except known primary hyperoxaluria. OurThe hypothesis is that compared to placebo, the administration [...] Thus far studies have shown lumasiran to be well tolerated. We will evaluateThe tolerability in this patient cohort will be evaluated and monitor inflammatory and cardiovascular biomarkers in addition to cardiac imaging with echocardiograms.
2024-01-17
Original filing
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.
Trial Details
NCT Number NCT06225544
Lead Sponsor Charite University, Berlin, Germany
Collaborators: Alnylam Pharmaceuticals
Conditions Haemodialysis, Chronic Kidney Disease Requiring Chronic Dialysis, Cardiovascular Disease, Cardiovascular Risk Factor, Hyperoxalemia
Enrollment 50 participants
Start Date 2024-04-14
Primary Completion 2025-01-30 (estimated)
Study Completion 2025-03-01 (estimated)
Updated on ClinicalTrials.gov 2024-08-21