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RECRUITING

NCT06225544

PHASE2

Lumasiran in Hyperoxalaemic Patients on Haemodialysis

Sponsor: Charite University, Berlin, Germany

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-04-14

Completion Date

2025-03-01

Last Updated

2024-08-21

Healthy Volunteers

Conditions

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

Interventions

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.

Inclusion Criteria: * Male or female patients * Aged between 18 and 80 years old at the start of the study. * Women of child-bearing potential to consent to either abstinence or the use of contraception during the study period * Patients must have capacity to give written, informed consent to participate in the study prior to commencing the study. They must be fully aware of the aims, nature, planned interventions and potential risks of participating in the study. This consent must be obtained by the time of participant inclusion. * Established and stable on haemodialysis for at least 2 months * Thrice weekly haemodialysis * In possession of permanent dialysis access - either arterio-venous fistula (AVF) or graft (AVG) or permanent dialysis catheter/tunnelled haemodialysis line (THL). * ESKD not caused by previously diagnosed primary hyperoxaluria. * Mean baseline serum oxalate level of ≥20 μmol/L * No recent (within last 2 months) significant changes to regular medications or diet Exclusion Criteria: * Known diagnosis of PH1, 2 or 3; or a pathological mutation documented to cause primary hyperoxaluria. * Established on haemodialysis for less than 2 months. * On peritoneal dialysis. * Combined haemodialysis and peritoneal dialysis. * Temporary or poorly functioning haemodialysis access * Pregnancy, planning pregnancy or currently breast feeding. * Co-morbidity of an enteric disorder such as Inflammatory Bowel Disease (IBD), short gut syndrome, 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 life expectancy of less than 1 year. * Currently relapsed or uncontrolled and symptomatic psychiatric disorder preventing compliance with the study. * Participants institutionalised by court or government order. * Patients who could be coerced due to dependency on the sponsor, the investigator, the trial sites or test centres. * Deranged liver function tests: If alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than twice the upper limit

Locations (1)

Charite Universtiätsmedizin

Berlin, Germany