13 completed, 2 recruiting. 15 Phase 2, 4 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 15 | Completed 13, Recruiting 2 |
| Phase 1 | 4 | Completed 3, Recruiting 1 |
| Phase 3 | 2 | Completed 2 |
Follow Hyperoxaluria, Primary: new trials by email Literature Review of Hyperoxaluria, Primary trials Research Report on Hyperoxaluria, Primary
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 |
|---|---|---|---|---|---|---|
| Study of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1 (PH1) YOLT-203, Placebo - Primary Hyperoxaluria Type 1, PH1 | Phase 2 | Recruiting | YolTech Therapeutics Co., Ltd | 36 | 2026-09-16 | 2026-10-09 |
| Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine) ABO-101 - Primary Hyperoxaluria Type 1 (PH1) | Phase 1 / Phase 2 | Recruiting | Arbor Biotechnologies | 23 | 2025-06-16 | 2026-10-19 |
| Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function nedosiran - Primary Hyperoxaluria, Primary Hyperoxaluria Type 1 | Phase 2 | Completed | Dicerna Pharmaceuticals, Inc., a Novo Nordisk company | 27 | 2022-02-22 | 2026-04-16 |
| A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2 DCR-PHXC, Sterile Normal Saline (0.9% NaCl) - Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2) | Phase 2 | Completed | Novo Nordisk A/S | 35 | 2019-10-28 | 2024-05-22 |
| Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria stiripentol (Diacomit) - Primary Hyperoxaluria | Phase 2 | Completed | Biocodex | 15 | 2019-05-21 | 2021-03-26 |
| Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia ALLN-177 - Enteric Hyperoxaluria, Primary Hyperoxaluria | Phase 2 | Completed | Allena Pharmaceuticals | 15 | 2018-07-17 | 2020-12-30 |
| 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 |
| Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis Oxalobacter formigenes - Primary Hyperoxaluria | Phase 2 | Completed | OxThera | 12 | 2014-05-19 | 2022-01-10 |
| Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria Oxabact OC5 capsules, Placebo capsules - Primary Hyperoxaluria | Phase 1 / Phase 2 | Completed | OxThera | 28 | 2013-12-01 | 2015-10-16 |
| Hydroxyproline Influence on Oxalate Metabolism Hydroxyproline and Leucine - Hyperoxaluria | Phase 1 / Phase 2 | Completed | Mayo Clinic | 22 | 2013-09-01 | 2017-07-02 |
| Trial on Treatment of Patients With Primary Hyperoxaluria Type I With Pyridoxal-phosphate Vitamin B 6 - Primary Hyperoxaluria Type I | Phase 2 | Completed | University of Cologne | 12 | 2010-12-01 | 2012-10-29 |
| Phase 2/3 Oxabact Study Oxalobacter formigenes, Placebo - Primary Hyperoxaluria | Phase 2 / Phase 3 | Completed | OxThera | 36 | 2009-12-01 | 2013-05-15 |
| 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 |
| Efficacy of Betaine for Reduction of Urine Oxalate in Patients With Type 1 Primary Hyperoxaluria Betaine, Placebo - Hyperoxaluria | Phase 2 | Completed | Mayo Clinic | 15 | 2007-02-01 | 2013-12-16 |
Hyperoxaluria (9) · Primary hyperoxaluria type 1 (5) · Genetic Diseases, Inborn (2) · Kidney Calculi (2) · Kidney Diseases (2) · Primary hyperoxaluria type 2 (2) · Urologic Diseases (2) · Metabolic Diseases (1) · Metabolism, Inborn Errors (1)
Carbohydrate Metabolism, Inborn Errors (15) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (15) · Female Urogenital Diseases (15) · Female Urogenital Diseases and Pregnancy Complications (15) · Male Urogenital Diseases (15) · Nutritional and Metabolic Diseases (15) · Urogenital Diseases (15) · Metabolic Diseases (14) · Metabolism, Inborn Errors (14) · Genetic Diseases, Inborn (13) · Kidney Diseases (13) · Urologic Diseases (13) · Hyperoxaluria (6) · Calculi (2) · Nephrolithiasis (2)
lumasiran (2) · nedosiran (2) · Betaine (1) · Hydroxyproline (1) · Lactose (1) · Leucine (1) · Vitamin B 6 (1) · oxalate decarboxylase (1) · reloxaliase (1) · stiripentol (1)
OxThera (4) · Alnylam Pharmaceuticals (2) · Mayo Clinic (2) · Allena Pharmaceuticals (1) · Arbor Biotechnologies (1) · Biocodex (1) · Dicerna Pharmaceuticals, Inc., a Novo Nordisk company (1) · Novo Nordisk A/S (1) · University of Cologne (1) · YolTech Therapeutics Co., Ltd (1)
Germany (10) · United States (9) · United Kingdom (7) · France (6) · Netherlands (4) · Israel (3) · Canada (2) · Italy (2) · Japan (2) · Lebanon (2) · Poland (2) · Spain (2) · Australia (1) · New Zealand (1) · Romania (1)
Bernd Hoppe, MD PhD (1) · Carla G Monico, M.D. (1) · Daniel Ory, MD (1) · David Clark, MD (1) · Dawn Milliner, M.D (1) · Dawn Milliner, M.D. (1) · Gesa Schalk, M.D. (1) · John C Lieske, MD (1) · Sarb Shergill, PhD (1) · Tracy McGregor, MD, MSCI (1) · Wensu Yu (1)
PMID 40193200, PMID 40601241, PMID 24385516, PMID 33985991, PMID 36007597, PMID 39875734, PMID 41388232
2015 (1), 2016 (1), 2017 (1), R01DK073354 (1), U54DK083908 (1)