Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Provided informed consent
  2. Age 18 or older
  3. 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)
  4. Urinary Oxalate ≥ 50mg/24h

Exclusion Criteria

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ALLN-177
ALLN-177 3,750 units per capsule
  • Drug: ALLN-177
    ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days
    Other names:
    • Oxalate decarboxylase
Placebo Comparator
Placebo
Placebo capsule
  • Drug: Placebo
    Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

NCT ID
NCT03456830
Status
Recruiting
Sponsor
Allena Pharmaceuticals

Study Contact

Allena Pharmaceuticals, Inc
617-467-4577
clinical301@allenapharma.com

Detailed Description

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.