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Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03456830
Recruitment Status : Completed
First Posted : March 7, 2018
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Allena Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Enteric Hyperoxaluria Drug: ALLN-177 Drug: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
Actual Study Start Date : May 21, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 28, 2019
Arms and Interventions
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Arm Intervention/treatment
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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 [ Time Frame: 4 weeks ]
    Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment


Secondary Outcome Measures :
  1. Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4 [ Time Frame: 4 weeks ]
    Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456830


Locations
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Sponsors and Collaborators
Allena Pharmaceuticals
Investigators
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Study Director: Annamaria Kausz, MD MS Allena Pharmaceuticals Inc
More Information
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Publications:

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Responsible Party: Allena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03456830    
Other Study ID Numbers: ALLN-177-301
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Allena Pharmaceuticals:
Kidney stones
Hyperoxaluria
Enteric hyperoxaluria
Oxalate