Lumasiran treatment for patients on dialysis with high oxalate levels
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
This study is testing if a new drug called lumasiran can help lower high oxalate levels in the blood of patients on dialysis for kidney disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06225544 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of lumasiran, a drug designed to reduce oxalate levels in the blood, in patients undergoing haemodialysis due to end-stage kidney disease. The study is a double-blind, phase II trial where participants are randomly assigned to receive either lumasiran or a placebo. The primary goal is to determine if lumasiran can significantly lower pre-dialysis oxalate levels over a period of 3-6 months, while also monitoring cardiovascular health and tolerability. Monthly plasma oxalate measurements and cardiac assessments will be conducted to evaluate the drug's impact.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who are stable on haemodialysis and have elevated serum oxalate levels.
Not a fit: Patients with end-stage kidney disease caused by primary hyperoxaluria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the health outcomes of dialysis patients by lowering oxalate levels and potentially reducing cardiovascular risks.
How similar studies have performed: Previous studies have shown lumasiran to be well tolerated, indicating potential for success in this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin
- Charite Universtiätsmedizin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Felix Knauf, MD — Charite Universitätsmedizin
- Study coordinator: Gerlineke MC Hawkins-van der Cingel, MBBS
- Email: gerlineke.hawkins-van-der-cingel@charite.de
- Phone: + 49 030 450 530067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.