8 completed, 2 terminated, 1 active not recruiting, 1 not yet recruiting. 13 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 8, Terminated 2, Active not recruiting 1, Not yet recruiting 1, Withdrawn 1 |
| Phase 2 | 2 | Completed 2 |
Follow Hyperoxaluria: new trials by email Literature Review of Hyperoxaluria trials Research Report on Hyperoxaluria
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 |
|---|---|---|---|---|---|---|
| Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3 Stiripentol Oral Capsule, Placebo Oral Capsule, Urine samples collect - Primary Hyperoxaluria Type 1, Primary Hyperoxaluria Type 2 | Phase 3 | Not yet recruiting | Biocodex | 42 | 2024-08-01 | 2024-06-18 |
| 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 |
| Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria Reloxaliase, Placebo - Enteric Hyperoxaluria | Phase 3 | Terminated | Allena Pharmaceuticals | 92 | 2019-08-26 | 2022-06-10 |
| Long Term Extension Study in Patients With Primary Hyperoxaluria DCR-PHXC - Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2) | Phase 3 | Active not recruiting | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | 75 | 2019-07-09 | 2026-10-08 |
| 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 |
| An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria Oxabact OC5 - Oxalobacter formigenes Strain HC-1 - Hyperoxaluria, Primary | Phase 3 | Terminated | OxThera | 22 | 2019-03-14 | 2021-12-08 |
| 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 |
| Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria ALLN-177, Placebo - Enteric Hyperoxaluria | Phase 3 | Completed | Allena Pharmaceuticals | 115 | 2018-05-21 | 2020-02-27 |
| A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria Oxabact OC5 - Oxalobacter formigenes HC-1, Placebo - Primary Hyperoxaluria | Phase 3 | Completed | OxThera | 25 | 2018-01-09 | 2021-12-10 |
| Lanthanum Carbonate (Fosrenol®) to Reduce Oxalate Excretion in Patients With Secondary Hyperoxaluria and Nephrolithiasis Lanthanum Carbonate - Secondary Hyperoxaluria, Nephrolithiasis | Phase 3 | Completed | Universitair Ziekenhuis Brussel | 54 | 2017-08-18 | 2026-08-10 |
| Phase 2/3 Oxabact Study Oxalobacter formigenes, Placebo - Primary Hyperoxaluria | Phase 2 / Phase 3 | Completed | OxThera | 36 | 2009-12-01 | 2013-05-15 |
| Renal Protective Effect of ACEI and ARB in Primary Hyperoxaluria ACEI / Angiotensin converting enzyme inhibitor, ARB /Angiotensin Receptor Blocker, Placebo - Hyperoxaluria | Phase 3 | Withdrawn | Mayo Clinic | 2007-12-01 | 2015-04-07 | |
| Study to Evaluate the Efficacy and Safety of OxabactTM on Reduction of Urinary Oxalate in Primary Hyperoxaluria Patients Oxalobacter formigenes, Placebo - Primary Hyperoxaluria | Phase 2 / Phase 3 | Completed | OxThera | 43 | 2007-10-01 | 2013-05-15 |
Hyperoxaluria, Primary (10) · Primary hyperoxaluria type 1 (5) · Kidney Calculi (2) · Primary hyperoxaluria type 2 (2) · Genetic Diseases, Inborn (1) · Kidney Diseases (1) · Nephrolithiasis (1) · Urolithiasis (1) · Urologic Diseases (1)
Female Urogenital Diseases (13) · Female Urogenital Diseases and Pregnancy Complications (13) · Male Urogenital Diseases (13) · Urogenital Diseases (13) · Kidney Diseases (12) · Urologic Diseases (12) · Carbohydrate Metabolism, Inborn Errors (10) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (10) · Metabolic Diseases (10) · Metabolism, Inborn Errors (10) · Nutritional and Metabolic Diseases (10) · Genetic Diseases, Inborn (9) · Calculi (2) · Nephrolithiasis (2)
lumasiran (3) · oxalate decarboxylase (2) · reloxaliase (2) · Angiotensin Receptor Antagonists (1) · Angiotensin-Converting Enzyme Inhibitors (1) · Lisinopril (1) · Losartan (1) · lanthanum carbonate (1) · nedosiran (1) · stiripentol (1)
OxThera (4) · Alnylam Pharmaceuticals (3) · Allena Pharmaceuticals (2) · Biocodex (1) · Dicerna Pharmaceuticals, Inc., a Novo Nordisk company (1) · Mayo Clinic (1) · Universitair Ziekenhuis Brussel (1)
United States (10) · Germany (8) · France (7) · United Kingdom (7) · Belgium (5) · Spain (5) · Italy (4) · Netherlands (4) · Canada (3) · Israel (3) · Australia (2) · Lebanon (2) · Switzerland (2) · Tunisia (2) · Turkey (Türkiye) (2)
Gesa Schalk, MD (2) · Annamaria Kausz, MD MS (1) · Christian Tielemans, MD, PhD (1) · David Clark, MD (1) · Dawn Milliner, M.D (1) · Dawn Milliner, M.D. (1) · Dawn S Milliner, M.D. (1) · Verity Rawson, MB.CHB (1)
PMID 38332115, PMID 33789010, PMID 34906487, PMID 35843439, PMID 35913563, PMID 38319254, PMID 39355649, PMID 40193200, PMID 40601241, PMID 41343248
2018 (3), 2023 (2), 2019 (1)