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New treatment option for Haemodialysis
Official title Lumasiran in Hyperoxalaemic Patients on Haemodialysis
ClinicalTrials.gov ID: NCT06225544
What this study is testing
What is Lumasiran?
Lumasiran is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for haemodialysis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Established and stable on haemodialysis for at least 2 months
You likely can't join if
- 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.
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.