Primary Hyperoxaluria Clinical Trial
Official title:
Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Verified date | February 2020 |
Source | Allena Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 15 |
Est. completion date | December 13, 2019 |
Est. primary completion date | December 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: 1. Signed a informed consent form or an assent 2. Aged 12 or older with body weight = 35kg 3. History of primary hyperoxaluria or enteric hyperoxaluria associated with a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome) 4. Urinary oxalate = 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2 5. In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening 6. In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening 7. Patients on dialysis, must be stable for greater than 3 months Exclusion Criteria: 1. Unable or unwilling to discontinue Vitamin C supplementation |
Country | Name | City | State |
---|---|---|---|
Germany | Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin | Berlin | |
United Kingdom | Leeds General Infirmary | Leeds | |
United Kingdom | Freeman Hospital | Newcastle | |
United Kingdom | Royal Preston Hospital | Preston | Lancashire |
United Kingdom | Wellcome Trust Clinical Research Facility | Southampton | Hampshire |
United States | Applied Research Center of Arkansas | Little Rock | Arkansas |
United States | Yale University School of Medicine | New Haven | Connecticut |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Mayo Clinic | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Allena Pharmaceuticals |
United States, Germany, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in plasma oxalate | Efficacy will be assessed based on change from baseline in plasma oxalate | on 12 weeks of treatment | |
Secondary | Change in 24-hr urinary oxalate excretion | Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion | on 12 weeks of treatment |
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