RecruitingPhase 2NCT06225544

Lumasiran in Hyperoxalaemic Patients on Haemodialysis


Sponsor

Charite University, Berlin, Germany

Enrollment

50 participants

Start Date

Apr 14, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing lumasiran — a drug already approved for a rare genetic condition that causes very high oxalate levels — in hemodialysis patients who have high oxalate levels in the blood for other reasons. High oxalate builds up in patients with kidney failure and can cause additional organ damage. **You may be eligible if...** - You are between 18 and 80 years old - You are on hemodialysis three times a week for at least 2 months - Your average blood oxalate level is 20 μmol/L or above - You have stable kidney failure (end-stage kidney disease) that was not caused by a known primary hyperoxaluria genetic condition - You have not had major medication or diet changes in the past 2 months **You may NOT be eligible if...** - You have a confirmed genetic cause of primary hyperoxaluria (PH1, PH2, or PH3) - You are on peritoneal dialysis - You are pregnant, planning to become pregnant, or breastfeeding - You have active inflammatory bowel disease, short gut syndrome, or a malabsorptive condition - You have severe liver disease - You have an active infection - You take more than 250 mg of vitamin C daily - Your life expectancy is less than 1 year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLumasiran

Subcutaneous injection, given as three monthly loading doses followed by one further maintenance dose.

DRUG0.9% Sodium Chloride (placebo)

Placebo, subcutaneous injection, given as three monthly loading doses followed by one further maintenance dose.


Locations(1)

Charite Universtiätsmedizin

Berlin, Germany

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NCT06225544


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