Clinical trials: Hyperoxaluria
Healthy, Enteric Hyperoxaluria
Safety and Tolerability of FB-001 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
This Phase 1, first-in-human, randomized, double-blinded, placebo controlled study is evaluating FB-001 in healthy volunteers (Part 1) and participants diagnosed with enteric hyperoxaluria (Part 2).
- Trial name
- NCT05650112
- Testing
- FB-001
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Federation Bio Inc.
Primary Hyperoxaluria
A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
This study will evaluate the efficacy and safety of OC5 in patients with PH.
- Trial name
- NCT03116685
- Testing
- Oxabact OC5 - Oxalobacter formigenes HC-1
- Where
- 10 sites in United States, Belgium and 5 more
- Volunteers
- 25 people
- Sponsor
- OxThera
Primary Hyperoxaluria Type 3
Natural History of Patients With PH3 and a History of Stone Events
This is a natural history study of adults, adolescents, and children (starting at birth) with genetically confirmed primary hyperoxaluria type 3 (PH3) who have a history of stone events during the last 3 years and/or the presence…
- Trial name
- PHYOX-OBX (NCT04542590)
- Where
- 6 sites in United States, Canada and 3 more
- Volunteers
- 7 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Primary Hyperoxaluria Type 1
BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)
The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.
- Trial name
- BONAPH1DE (NCT04982393)
- Where
- 30 sites in United States, Belgium and 9 more
- Volunteers
- 207 people
- Sponsor
- Alnylam Pharmaceuticals
Primary Hyperoxaluria Type 1, End Stage Renal Disease
Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD
The aim of this study is to evaluate DCR-PHXC in participants with PH1 and severe renal impairment, with or without dialysis.
- Trial name
- PHYOX7 (NCT04580420)
- Testing
- DCR-PHXC
- Where
- 18 sites in United States, France and 8 more
- Volunteers
- 28 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Enteric Hyperoxaluria
Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
- Trial name
- NCT03456830
- Testing
- ALLN-177
- Where
- 63 sites in United States, Canada and 5 more
- Volunteers
- 115 people
- Sponsor
- Allena Pharmaceuticals
Primary Hyperoxaluria Type 1, Primary Hyperoxaluria
A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).
- Trial name
- ILLUMINATE-C (NCT04152200)
- Testing
- Lumasiran
- Where
- 14 sites in United States, Australia and 9 more
- Volunteers
- 21 people
- Sponsor
- Alnylam Pharmaceuticals
Enteric Hyperoxaluria
Safety, Tolerability, and Pharmacodynamics of SYNB8802v1 in Subjects With History of Gastric Bypass Surgery or Short-bowel Syndrome
Study SYNB8802-CP-002 is designed to assess safety, tolerability, and oxalate lowering, in subjects with a history of gastric bypass surgery or short-bowel syndrome.
- Trial name
- NCT05377112
- Testing
- SYNB8802v1
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Synlogic
Hyperoxaluria, Nonalcoholic Fatty Liver Disease
A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria
The purpose of this study is to test the safety of BMN 255 and to learn about the effect BMN 255 has on you and your hyperoxaluria associated with NAFLD, and compare these effects with a placebo.
- Conditions
- Hyperoxaluria, Nonalcoholic Fatty Liver Disease, Kidney Stone
- Trial name
- NCT06138327
- Testing
- BMN 255
- Where
- 7 sites in United States
- Sponsor
- BioMarin Pharmaceutical
Primary Hyperoxaluria Type 1 (PH1)
Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of lumasiran in healthy adult volunteers and subjects…
- Trial name
- NCT02706886
- Testing
- Lumasiran
- Where
- 9 sites in France, Germany and 3 more
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2)
Long Term Extension Study in Patients With Primary Hyperoxaluria
The proposed study is designed to provide patients previously enrolled in Phase 1 and 2 studies of DCR-PHXC and their siblings (<18 years old) long-term access to DCR-PHXC, and to evaluate the long-term safety and efficacy of…
- Conditions
- Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2), Kidney Diseases, Urologic Diseases
- Trial name
- PHYOX3 (NCT04042402)
- Testing
- DCR-PHXC
- Where
- 23 sites in United States, Australia and 11 more
- Volunteers
- 75 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Primary Hyperoxaluria
Phase 2/3 Oxabact Study
The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
- Trial name
- NCT01037231
- Testing
- Oxalobacter formigenes
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 36 people
- Sponsor
- OxThera
Secondary Hyperoxaluria, Nephrolithiasis
A Pilot Study of Oxalate Absorption in Secondary Hyperoxaluria
Identify individuals with greater absorption of oxalate based on increase in urinary oxalate excretion in response to a controlled oxalate-rich test meal.
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones
- Trial name
- NCT03095885
- Testing
- Test Meal
- Where
- 5 sites in United States
- Volunteers
- 22 people
- Sponsor
- Allena Pharmaceuticals
Primary Hyperoxaluria
Expanded Access Protocol to Provide Lumasiran to Patients With Primary Hyperoxaluria Type 1
The purpose of this study is to provide expanded access to lumasiran for adults and pediatric patients with Primary Hyperoxaluria Type 1 (PH1),
- Trial name
- NCT04125472
- Testing
- Lumasiran
- Sponsor
- Alnylam Pharmaceuticals
Secondary Hyperoxaluria, Nephrolithiasis
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Hyperoxaluria and Kidney Stones
The purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of ALLN 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis, Kidney Stones, Hyperoxaluria
- Trial name
- NCT02503345
- Testing
- ALLN-177 low dose, ALLN-177 mid dose, ALLN-177 high dose
- Where
- 16 sites in United States
- Volunteers
- 32 people
- Sponsor
- Allena Pharmaceuticals
Healthy Volunteers, Enteric Hyperoxaluria
Safety, Tolerability, and Pharmacodynamics of NOV-001 in Adult Subjects
The first stage of this study is a prospective, adaptive, Phase 1, first-in-human, randomized, controlled study evaluating safety, tolerability, and pharmacodynamics of NOV-001 in adult healthy volunteers.
- Trial name
- NCT04909723
- Testing
- NOV-001, NB1000S, NB2000P
- Where
- 20 sites in United States, Canada
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novome Biotechnologies Inc
Hyperoxaluria, Primary
An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Open label extension study of Oxabact OC5 in patients with primary hyperoxaluria
- Trial name
- ePHex-OLE (NCT03938272)
- Testing
- Oxabact OC5 - Oxalobacter formigenes Strain HC-1
- Where
- 8 sites in United States, Belgium and 4 more
- Volunteers
- 22 people
- Sponsor
- OxThera
Primary Hyperoxaluria Type 1, PH1
Study of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1 (PH1)
This study will be conducted to evaluate the efficacy and safety of YOLT-203 in children and adults with Primary Hyperoxaluria Type 1.
- Trial name
- NCT07587021
- Testing
- YOLT-203
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- YolTech Therapeutics Co., Ltd
Primary Hyperoxaluria, Primary Hyperoxaluria Type 1
Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function
The aim of this study is to evaluate nedosiran in participants 11 years of age and younger who have Primary Hyperoxaluria with relatively intact renal function.
- Conditions
- Primary Hyperoxaluria, Primary Hyperoxaluria Type 1, Primary Hyperoxaluria Type 2, Primary Hyperoxaluria Type 3
- Trial name
- PHYOX8 (NCT05001269)
- Testing
- nedosiran
- Where
- 13 sites in United States, Canada and 9 more
- Volunteers
- 27 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Healthy, Enteric Hyperoxaluria
Safety and Tolerability of SYNB8802 in Healthy Adult Volunteers and Adult Subjects With Enteric Hyperoxaluria
This Phase 1a/b, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB8802 in healthy volunteers (HV) and subjects diagnosed with enteric hyperoxaluria (EH).
- Trial name
- NCT04629170
- Testing
- SYNB8802
- Where
- 4 sites in United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Synlogic