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Trial record 1 of 7 for:    ALLN-177 | Hyperoxaluria
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Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

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: NCT03391804
Recruitment Status : Completed
First Posted : January 5, 2018
Last Update Posted : December 30, 2020
Sponsor:
Information provided by (Responsible Party):
Allena Pharmaceuticals

Study Description
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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

Condition or disease Intervention/treatment Phase
Enteric Hyperoxaluria Primary Hyperoxaluria Hyperoxalemia Drug: ALLN-177 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : December 13, 2019
Actual Study Completion Date : December 13, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ALLN-177
ALLN-177 7,500 units (2 capsules)
 Drug: ALLN-177
ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks
Other Name: Oxalate decarboxylase


Outcome Measures
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Primary Outcome Measures :
  1. Change in plasma oxalate [ Time Frame: on 12 weeks of treatment ]
    Efficacy will be assessed based on change from baseline in plasma oxalate


Secondary Outcome Measures :
  1. Change in 24-hr urinary oxalate excretion [ Time Frame: on 12 weeks of treatment ]
    Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03391804


Locations
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United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Arkansas
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72212
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Germany
Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin
Berlin, Germany, 10117
United Kingdom
Wellcome Trust Clinical Research Facility
Southampton, Hampshire, United Kingdom, SO16 6YD
Royal Preston Hospital
Preston, Lancashire, United Kingdom, PR2 9HT
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Freeman Hospital
Newcastle, United Kingdom, NE7 7 DN
Sponsors and Collaborators
Allena Pharmaceuticals
Investigators
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Study Director: David Clark, MD Allena Pharmaceuticals Inc
More Information
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Responsible Party: Allena Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03391804    
Other Study ID Numbers: ALLN-177-206
2017-003547-38 ( EudraCT Number )
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: December 30, 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:
Oxalate
Kidney Stones
oxalate nephropathy
systemic oxalosis
Additional relevant MeSH terms:
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Hyperoxaluria, Primary
Hyperoxaluria
Kidney Diseases
Urologic Diseases
 Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases