Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Completed · Phase 2
Conditions studied: Enteric Hyperoxaluria, Primary Hyperoxaluria, Hyperoxalemia
In brief
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
Key facts
- Study ID
- NCT03391804
- Run by
- Allena Pharmaceuticals
- People needed
- 15
- Starts
- 2018-07-17
- Expected to finish
- 2019-12-13
- Last updated by the study team
- 2020-12-30
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed a informed consent form or an assent
- Aged 12 or older with body weight ≥ 35kg
- 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)
- Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2
- In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening
- In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening
- Patients on dialysis, must be stable for greater than 3 months
You may not qualify if…
- Unable or unwilling to discontinue Vitamin C supplementation
Where it is running
- Mayo Clinic — Scottsdale, Arizona, 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
- Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin — Berlin, Germany
- Wellcome Trust Clinical Research Facility — Southampton, Hampshire, United Kingdom
- Royal Preston Hospital — Preston, Lancashire, United Kingdom
- Leeds General Infirmary — Leeds, United Kingdom
- Freeman Hospital — Newcastle, United Kingdom
Full record on ClinicalTrials.gov
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