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

Allena Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hyperoxalemia; Primary Hyperoxaluria; Enteric Hyperoxaluria

Treatments: Drug: ALLN-177

Study type: Interventional

Funder types: Industry

Identifiers

NCT03391804

ALLN-177-206

2017-003547-38 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria .

Approximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.

Enrollment: 15 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

ALLN-177

Experimental group

Description:

ALLN-177 7,500 units (2 capsules)

Treatment:

Drug: ALLN-177