Actively Recruiting
Lumasiran Treatment Compared to Placebo in Patients on Haemodialysis with High Oxalate Levels
Led by Charite University, Berlin, Germany · Updated on 2024-08-21
50
Participants Needed
1
Research Sites
4 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 research aims to evaluate a drug called lumasiran in patients with kidney disease who require haemodialysis and have high levels of oxalate in their blood. People with kidney disease often face higher risks of heart attacks, heart disease, and strokes, possibly linked to elevated oxalate levels. The study will investigate whether lumasiran can reduce oxalate levels in these patients and monitor any changes in their heart health using echocardiograms. Participants will be randomly assigned to receive either lumasiran or a placebo, both given as subcutaneous injections with three monthly loading doses followed by one maintenance dose. The study is double-blind, meaning neither the participants nor the doctors will know which treatment is given until the study concludes. Monthly blood tests will measure pre-dialysis plasma oxalate levels, and echocardiograms will be performed at the start and after six months. During the study, participants will attend monthly visits for blood tests alongside their dialysis sessions, and heart ultrasounds will be done at baseline and six months to assess cardiac changes. Researchers will monitor oxalate levels, side effects, inflammatory and cardiovascular biomarkers, and overall tolerability of lumasiran. The study duration is six months, with data collected regularly to evaluate the drug's impact on oxalate reduction and heart health.
CONDITIONS
Brief 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 contraception during the study
- Ability to give informed written consent
- Stable on haemodialysis for at least 2 months
- Receiving haemodialysis three times weekly
- Have permanent dialysis access (arterio-venous fistula, graft, or permanent catheter)
- End stage kidney disease not caused by primary hyperoxaluria
- Mean baseline serum oxalate level of at least 20 bcmol/L
- No significant medication or diet changes in the past 2 months
You will not qualify if you...
- Diagnosed with primary hyperoxaluria (PH1, PH2, PH3) or known genetic mutation causing it
- On haemodialysis for less than 2 months
- Receiving peritoneal dialysis or combined dialysis types
- Temporary or poorly functioning dialysis access
- Pregnant, planning pregnancy, or breastfeeding
- Have enteric disorders like inflammatory bowel disease, short gut syndrome, or malabsorptive conditions
- Decompensated liver failure
- Current active infection or on antibiotic treatment
- Taking more than 250mg daily of Vitamin C
- Terminal illness or life expectancy under 1 year
- Uncontrolled psychiatric disorders affecting study compliance
- Institutionalized by court or government order
- Dependent on the sponsor, investigator, or trial site
- Liver function tests more than twice the upper limit for ALT or AST
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive subcutaneous injections of lumasiran or placebo as three monthly loading doses followed by one maintenance dose. Monthly pre-dialysis plasma oxalate measurements and assessments of tolerability, inflammatory and cardiovascular biomarkers, and cardiac imaging are performed.
Monthly visits for 6 months
Trial Site Locations
Total: 1 location
1
Charite Universtiätsmedizin
Berlin, Germany
Actively Recruiting
Research Team
G
Gerlineke MC Hawkins-van der Cingel, MBBS
F
Felix Knauf, MD
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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