Lumasiran in Hyperoxalaemic Patients on Haemodialysis
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 di
| Condition(s) | Haemodialysis, Chronic Kidney Disease Requiring Chronic Dialysis, Cardiovascular Disease, Cardiovascular Risk Factor, Hyperoxalemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | 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). * ES |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Charite University, Berlin, Germany |
| Locations | Berlin, Germany |
| Start date | 2024-04-14 |
| NCT ID | NCT06225544 |
| Official listing | https://clinicaltrials.gov/study/NCT06225544 |