Actively Recruiting
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
Led by Charite University, Berlin, Germany · Updated on 2024-08-21
50
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
Sponsors
C
Charite University, Berlin, Germany
Lead Sponsor
A
Alnylam Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients
- Aged between 18 and 80 years old at the start of the study
- Women of child-bearing potential must agree to abstinence or use contraception during the study
- Ability to provide written informed consent before starting the study
- Stable haemodialysis treatment for at least 2 months
- Receiving haemodialysis three times per week
- Permanent dialysis access such as arteriovenous fistula, graft, or permanent catheter
- End-stage kidney disease not caused by primary hyperoxaluria
- Mean baseline serum oxalate level of 20 micromol/L or higher
- No significant changes to regular medications or diet within the last 2 months
You will not qualify if you...
- Known diagnosis of primary hyperoxaluria type 1, 2, or 3 or related genetic mutation
- On haemodialysis for less than 2 months
- Receiving peritoneal dialysis or combined haemodialysis and peritoneal dialysis
- Temporary or poorly functioning haemodialysis access
- Pregnant, planning pregnancy, or breastfeeding
- Having inflammatory bowel disease, short gut syndrome, or malabsorption disorder
- Decompensated liver failure
- Active infection or currently on antibiotic treatment
- Taking more than 250 mg of Vitamin C daily
- Terminal illness or life expectancy less than 1 year
- Uncontrolled psychiatric disorder preventing study compliance
- Institutionalized by court or government order
- Potential coercion due to dependency on study staff or sponsors
- Liver function tests showing ALT or AST more than twice the upper limit
AI-Screening
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Trial Site Locations
Total: 1 location
1
Charite Universtiätsmedizin
Berlin, Germany
Actively Recruiting
Research Team
G
Gerlineke MC Hawkins-van der Cingel, MBBS
CONTACT
F
Felix Knauf, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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