Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03456830
Previous Study | Return to List | Next Study

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

Tracking Information
First Submitted Date  ICMJE March 1, 2018
First Posted Date  ICMJE March 7, 2018
Last Update Posted Date February 27, 2020
Actual Study Start Date  ICMJE May 21, 2018
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
Percent change from baseline in 24-hour urinary oxalate excretion [ Time Frame: 4 weeks ]
Efficacy will be assessed based on percent change from baseline in 24-hr urinary oxalate excretion
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion [ Time Frame: 4 weeks ]
Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion over 4 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
Official Title  ICMJE Evaluate the Safety and Efficacy of ALLN-177 in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
Brief Summary The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Enteric Hyperoxaluria
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days
Study Arms  ICMJE
  • Experimental: ALLN-177
    ALLN-177 3,750 units per capsule
    Intervention: Drug: ALLN-177
  • Placebo Comparator: Placebo
    Placebo capsule
    Intervention: Drug: Placebo
Publications * Langman CB, Grujic D, Pease RM, Easter L, Nezzer J, Margolin A, Brettman L. A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme. Am J Nephrol. 2016;44(2):150-8. doi: 10.1159/000448766. Epub 2016 Aug 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2020)
115
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2018)
124
Actual Study Completion Date  ICMJE October 28, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03456830
Other Study ID Numbers  ICMJE ALLN-177-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Allena Pharmaceuticals
Study Sponsor  ICMJE Allena Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Annamaria Kausz, MD MS Allena Pharmaceuticals Inc
PRS Account Allena Pharmaceuticals
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP