CompletedPhase 2

Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

United States, Germany15 participantsStarted 2018-07-17

Plain-language summary

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

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

Change in plasma oxalate

Timeframe: on 12 weeks of treatment

Trial details

NCT IDNCT03391804

SponsorAllena Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12-13

View on ClinicalTrials.gov More Enteric Hyperoxaluria trials