| Trial ID: | L1382 |
| Source ID: | NCT06225544
|
| Associated Drug: |
Lumasiran
|
| Title: |
Lumasiran in Hyperoxalaemic Patients on Haemodialysis
|
| Acronym: |
LHOxH
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Haemodialysis|Chronic Kidney Disease Requiring Chronic Dialysis|Cardiovascular Disease|Cardiovascular Risk Factor|Hyperoxalemia
|
| Interventions: |
DRUG: Lumasiran|DRUG: 0.9% Sodium Chloride (placebo)
|
| Outcome Measures: |
Primary: Pre-dialysis Plasma Oxalate concentration, The primary endpoint is the percentage change in pre-dialysis plasma oxalate levels in non-primary hyperoxaluria patients with raised plasma oxalate levels who are receiving maintenance haemodialysis., It will be measured at baseline and month 1-6 (weeks 4, 8, 12, 16, 20 and 24). | Secondary: Absolute change in pre-dialysis mean plasma, Absolute change in pre-dialysis mean plasma oxalate levels from baseline to month 3-6, comparing the treatment group with the placebo group., Baseline to month 3-6,|Side effects (tolerability), Tolerability will be assessed using an adapted FACIT Instrument validated questionnaire (severity of side effects rated on scale between 0 and 4). Again, the answers of the two study arms will be compared., Monthly - month 0-6
|
| Sponsor/Collaborators: |
Sponsor: Charite University, Berlin, Germany | Collaborators: Alnylam Pharmaceuticals
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2024-04-14
|
| Completion Date: |
2025-03-01
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-21
|
| Locations: |
Charite Universtiätsmedizin, Berlin, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT06225544
|
