Lumasiran in Hyperoxalaemic Patients on Haemodialysis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Charite Universtiätsmedizin
RECRUITING
Berlin
Contact Information
Primary
Gerlineke MC Hawkins-van der Cingel, MBBS
gerlineke.hawkins-van-der-cingel@charite.de
+ 49 030 450 530067
Backup
Felix Knauf, MD
felix.knauf@charite.de
+ 49 030 450 530066
Time Frame
Start Date: 2024-04-14
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 50
Treatments
Experimental: Lumasiran, treatment arm
Treatment arm with Lumasiran
Placebo_comparator: Placebo
Placebo injection with 0.9% sodium chloride
Related Therapeutic Areas
Sponsors
Collaborators: Alnylam Pharmaceuticals
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov