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

Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03391804

Enrollment

Registered

2018-01-05

Start date

2018-07-17

Completion date

2019-12-13

Last updated

2020-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteric Hyperoxaluria, Hyperoxalemia, Primary Hyperoxaluria

Keywords

Oxalate, Kidney Stones, oxalate nephropathy, systemic oxalosis

Brief 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

Detailed 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.

Interventions

DRUGALLN-177

ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change in plasma oxalate	on 12 weeks of treatment	Efficacy will be assessed based on change from baseline in plasma oxalate

Secondary

Measure	Time frame	Description
Change in 24-hr urinary oxalate excretion	on 12 weeks of treatment	Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion

Countries

Germany, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026