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Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria (URIROX-2)

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ClinicalTrials.gov Identifier: NCT03847090
Recruitment Status : Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Allena Pharmaceuticals

Brief Summary:
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

Condition or disease Intervention/treatment Phase
Enteric Hyperoxaluria Drug: Reloxaliase Drug: Placebo Phase 3

Detailed Description:
This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients With Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Reloxaliase
Reloxaliase (ALLN-177) 142 mg of oxalate decarboxylase (equivalent to 3,750 units of enzyme activity) per capsule
Drug: Reloxaliase
Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
Other Names:
  • ALLN-177
  • Oxalate decarboxylase

Placebo Comparator: placebo
placebo capsule
Drug: Placebo
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day
Other Name: Placebo capsule




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 average across Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment

  2. Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging) [ Time Frame: up to 48 months ]
    Efficacy will be assessed by comparing kidney stone disease progression rate on reloxaliase vs. placebo


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 average across Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment

  2. Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24 [ Time Frame: 24 weeks ]
    Efficacy will be assessed based on percent change from baseline to the average across Weeks 16-24, derived from all 24-hour collections during Weeks 16-24 on treatment

  3. Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones [ Time Frame: up to 48 months ]
    Efficacy will be assessed by comparing utilization on reloxaliase vs. placebo

  4. Change in estimated glomerular filtration rate (eGFR) from baseline [ Time Frame: up to 48 months ]
    Efficacy will be assessed by comparing the rate of change in eGFR on reloxaliase vs. placebo



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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 years or older
  3. Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
  4. Urinary oxalate ≥ 50 mg/24 hr
  5. Has at least 1 documented kidney stone within 2 years

Exclusion Criteria:

  1. Acute renal failure or estimated glomerular filtration rate (eGFR) < 30 mL/minute/1.73 m2
  2. Has a known genetic, congenital, or other cause of kidney stones
  3. Unable or unwilling to discontinue Vitamin C supplementation
  4. Cannot establish baseline kidney stone burden

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): NCT03847090


Contacts
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Contact: Allena Pharmaceuticals, Inc 617-467-4577 ext 398 clinical302@allenapharma.com

Sponsors and Collaborators
Allena Pharmaceuticals
Investigators
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Study Director: Annamaria Kausz, MD MS Allena Pharmaceuticals Inc

Additional Information:
Publications:
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Responsible Party: Allena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03847090     History of Changes
Other Study ID Numbers: ALLN-177-302
2018-000921-29 ( EudraCT Number )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
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 stone
hyperoxaluria
enteric hyperoxaluria
oxalate
kidney calcification