CompletedPhase 3

Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

United States115 participantsStarted 2018-05-21

Plain-language summary

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Provided informed consent
✓. Age 18 or older
✓. History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
✓. Urinary Oxalate ≥ 50mg/24h

✕. Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73 m2
✕. Unable or unwilling to discontinue Vitamin C supplementation

Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4

Timeframe: 4 weeks

NCT IDNCT03456830

SponsorAllena Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-30