5 completed, 1 approved for marketing, 1 terminated, 1 unknown. 4 Phase 2, 3 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 2, Terminated 1, Unknown 1 |
| Phase 3 | 3 | Completed 3 |
| Phase 1 | 1 | Completed 1 |
Follow lumasiran: new trials by email Literature Review of lumasiran trials Research Report on lumasiran
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Lumasiran in Hyperoxalaemic Patients on Haemodialysis Lumasiran, 0.9% Sodium Chloride (placebo) - Haemodialysis, Chronic Kidney Disease Requiring Chronic Dialysis | Phase 2 | Unknown | Charite University, Berlin, Germany | 50 | 2024-04-14 | 2024-08-21 |
| A Study to Evaluate Lumasiran in Adults With Recurrent Calcium Oxalate Kidney Stone Disease and Elevated Urinary Oxalate Levels Lumasiran, Placebo - Recurrent Calcium Oxalate Kidney Stone Disease, Elevated Urinary Oxalate Levels | Phase 2 | Terminated | Alnylam Pharmaceuticals | 2 | 2022-01-27 | 2024-05-22 |
| A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 Lumasiran - Primary Hyperoxaluria Type 1, Primary Hyperoxaluria | Phase 3 | Completed | Alnylam Pharmaceuticals | 21 | 2020-01-21 | 2025-07-18 |
| A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1 Lumasiran - Primary Hyperoxaluria, Primary Hyperoxaluria Type 1 (PH1) | Phase 3 | Completed | Alnylam Pharmaceuticals | 18 | 2019-04-22 | 2025-02-14 |
| A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1 Placebo, Lumasiran - Primary Hyperoxaluria Type 1 (PH1) | Phase 3 | Completed | Alnylam Pharmaceuticals | 39 | 2018-11-27 | 2024-08-12 |
| An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1 Lumasiran - PH1, Primary Hyperoxaluria | Phase 2 | Completed | Alnylam Pharmaceuticals | 20 | 2018-04-04 | 2024-04-25 |
| Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1 Lumasiran, Placebo - Primary Hyperoxaluria Type 1 (PH1) | Phase 1 / Phase 2 | Completed | Alnylam Pharmaceuticals | 52 | 2016-03-08 | 2020-01-30 |
| Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1 Lumasiran - Primary Hyperoxaluria | Approved for marketing | Alnylam Pharmaceuticals | 2024-02-16 |
Hyperoxaluria, Primary (6) · Hyperoxaluria (4) · Primary hyperoxaluria type 1 (4) · Genetic Diseases, Inborn (2) · Kidney Diseases (2) · Metabolic Diseases (2) · Metabolism, Inborn Errors (2) · Urologic Diseases (2) · Cardiovascular Diseases (1) · Kidney Calculi (1)
Alnylam Pharmaceuticals (7) · Charite University, Berlin, Germany (1)
France (5) · Germany (5) · Israel (5) · United Kingdom (5) · Netherlands (4) · United States (4) · Belgium (2) · Italy (2) · Switzerland (2) · United Arab Emirates (2) · Australia (1) · Jordan (1) · Lebanon (1) · Spain (1) · Turkey (Türkiye) (1)
Felix Knauf, MD (1) · Tracy McGregor, MD, MSCI (1)
PMID 38332115, PMID 33789010, PMID 33985991, PMID 34906487, PMID 35843439, PMID 35913563, PMID 39355649, PMID 41343248, PMID 41388232
2018 (2), 2015 (1), 2016 (1), 2019 (1), 2023 (1)