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

• Status: Completed
• Trial end date: 2019-12-13
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allena Pharmaceuticals

Criteria

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