18 completed. 18 Phase 2, 5 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 18 | Completed 18 |
| Phase 1 | 5 | Completed 5 |
| Phase 3 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days ALLN-177, Placebo - Secondary Hyperoxaluria, Nephrolithiasis | Phase 2 | Completed | Allena Pharmaceuticals | 66 | 2015-09-01 | 2017-01-19 |
| Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones ALLN-177 low dose, ALLN-177 mid dose, ALLN-177 high dose - Secondary Hyperoxaluria, Nephrolithiasis | Phase 2 | Completed | Allena Pharmaceuticals | 32 | 2015-07-01 | 2018-01-11 |
| Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria ALLN-177 - Hyperoxaluria, Nephrolithiasis | Phase 2 | Completed | Allena Pharmaceuticals | 16 | 2014-09-01 | 2019-06-05 |
| 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 |
| Oxazyme in Patients With Hyperoxaluria Oxazyme - Hyperoxaluria | Phase 1 / Phase 2 | Completed | Mayo Clinic | 22 | 2010-05-01 | 2012-12-24 |
| 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 |
| Use of Oral Probiotics to Reduce Urinary Oxalate Excretion Oxadrop, Agri-King Synbiotic (AKSB), Placebo - Nephrolithiasis, Hyperoxaluria | Phase 1 / Phase 2 | Completed | Mayo Clinic | 40 | 2006-02-01 | 2012-05-31 |
Hyperoxaluria, Primary (13) · Kidney Calculi (5) · Kidney Diseases (5) · Urologic Diseases (5) · Nephrolithiasis (4) · Primary hyperoxaluria type 1 (3) · Genetic Diseases, Inborn (2) · Primary hyperoxaluria type 2 (2) · Calculi (1) · Crohn Disease (1) · Metabolic Diseases (1) · Metabolism, Inborn Errors (1)
Female Urogenital Diseases (18) · Female Urogenital Diseases and Pregnancy Complications (18) · Male Urogenital Diseases (18) · Urogenital Diseases (18) · Carbohydrate Metabolism, Inborn Errors (13) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (13) · Kidney Diseases (13) · Nutritional and Metabolic Diseases (13) · Urologic Diseases (13) · Metabolic Diseases (12) · Metabolism, Inborn Errors (12) · Genetic Diseases, Inborn (11) · Pathological Conditions, Anatomical (5) · Pathological Conditions, Signs and Symptoms (5)
oxalate decarboxylase (5) · reloxaliase (4) · lumasiran (2) · nedosiran (2) · Betaine (1) · Hydroxyproline (1) · Lactose (1) · Leucine (1) · Vitamin B 6 (1) · stiripentol (1)
Allena Pharmaceuticals (4) · Mayo Clinic (4) · OxThera (4) · Alnylam Pharmaceuticals (2) · Biocodex (1) · Dicerna Pharmaceuticals, Inc., a Novo Nordisk company (1) · Novo Nordisk A/S (1) · University of Cologne (1)
United States (12) · Germany (9) · United Kingdom (6) · France (5) · Netherlands (4) · Israel (3) · Canada (2) · Italy (2) · Japan (2) · Lebanon (2) · Poland (2) · Spain (2) · Australia (1) · New Zealand (1) · Romania (1)
Annamaria Kausz, MD MS (2) · John C Lieske, MD (2) · Bernd Hoppe, MD PhD (1) · Carla G Monico, M.D. (1) · David Clark, MD (1) · Dawn Milliner, M.D (1) · Dawn Milliner, M.D. (1) · Gesa Schalk, M.D. (1) · John Lieske, MD (1) · Lee Brettman, MD, FACP (1) · Sarb Shergill, PhD (1) · Tracy McGregor, MD, MSCI (1)
PMID 40193200, PMID 40601241, PMID 20736987, PMID 24385516, PMID 30783888, PMID 33985991, PMID 36007597, PMID 39875734, PMID 41388232
2015 (1), 2016 (1), 2017 (1), P50DK083007 (1), R01DK073354 (1), R21AT002534 (1), U54DK083908 (1), UL1RR024150 (1)