Clinical trials: Hyperoxaluria
PH1, Primary Hyperoxaluria
An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the long-term safety and tolerability of lumasiran in participants with Primary Hyperoxaluria Type 1.
- Conditions
- PH1, Primary Hyperoxaluria, RNAi Therapeutic, siRNA
- Trial name
- NCT03350451
- Testing
- Lumasiran
- Where
- 9 sites in France, Germany and 3 more
- Volunteers
- 20 people
- Sponsor
- Alnylam Pharmaceuticals
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
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
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
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
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.
Enteric Hyperoxaluria
Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.
- Trial name
- URIROX-2 (NCT03847090)
- Testing
- Reloxaliase
- Where
- 113 sites in United States, Austria and 14 more
- Volunteers
- 92 people
- Sponsor
- Allena Pharmaceuticals
Primary Hyperoxaluria
Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis
The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.
- Trial name
- NCT02000219
- Testing
- Oxalobacter formigenes
- Where
- Germany
- Volunteers
- 12 people
- Sponsor
- OxThera
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
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
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
Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria
Evaluation of the efficacy of stiripentol (Diacomit) as monotherapy for the treatment of primary hyperoxaluria. Pilot clinical study, open, prospective and multicenter.
- Trial name
- NCT03819647
- Testing
- stiripentol (Diacomit)
- Where
- 3 sites in France
- Volunteers
- 15 people
- Sponsor
- Biocodex
Enteric Hyperoxaluria, Primary Hyperoxaluria
Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria
- Conditions
- Enteric Hyperoxaluria, Primary Hyperoxaluria, Hyperoxalemia
- Trial name
- NCT03391804
- Testing
- ALLN-177
- Where
- 9 sites in United States, Germany and 1 more
- Volunteers
- 15 people
- Sponsor
- Allena Pharmaceuticals
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 (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
Hyperoxaluria, Nephrolithiasis
Evaluating ALLN-177 for Reducing Urinary Oxalate Excretion in Calcium Oxalate Kidney Stone Formers With Hyperoxaluria
The purpose of this study is to evaluate the effect of ALLN-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.
- Trial name
- NCT02289755
- Testing
- ALLN-177
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Allena 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
Secondary Hyperoxaluria, Nephrolithiasis
Evaluate the Effect of ALLN-177 in Reducing Urinary Oxalate in Patients With Secondary Hyperoxaluria and Kidney Stones Over 28 Days
Evaluate the safety, tolerability, and efficacy of 28 days of treatment with ALLN-177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and kidney stones.
- Conditions
- Secondary Hyperoxaluria, Nephrolithiasis, Hyperoxaluria, Kidney Stones
- Trial name
- NCT02547805
- Testing
- ALLN-177
- Where
- 22 sites in United States
- Volunteers
- 66 people
- Sponsor
- Allena Pharmaceuticals
Primary Hyperoxaluria
Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria
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
- NCT02012985
- Testing
- Oxabact OC5 capsules
- Where
- 8 sites in France, Germany and 1 more
- Volunteers
- 28 people
- Sponsor
- OxThera
Primary Hyperoxaluria
Study to Evaluate the Efficacy and Safety of OxabactTM on Reduction of Urinary Oxalate in Primary Hyperoxaluria Patients
The main purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.
- Trial name
- PHOENIX (NCT00638703)
- Testing
- Oxalobacter formigenes
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- OxThera