Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Primary Purpose
Enteric Hyperoxaluria, Primary Hyperoxaluria, Hyperoxalemia
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALLN-177
Sponsored by
About this trial
This is an interventional treatment trial for Enteric Hyperoxaluria focused on measuring Oxalate, Kidney Stones, oxalate nephropathy, systemic oxalosis
Eligibility Criteria
Inclusion Criteria:
- Signed a informed consent form or an assent
- Aged 12 or older with body weight ≥ 35kg
- 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)
- Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2
- In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening
- In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening
- Patients on dialysis, must be stable for greater than 3 months
Exclusion Criteria:
1. Unable or unwilling to discontinue Vitamin C supplementation
Sites / Locations
- Mayo Clinic
- Applied Research Center of Arkansas
- Yale University School of Medicine
- Mayo Clinic
- Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin
- Wellcome Trust Clinical Research Facility
- Royal Preston Hospital
- Leeds General Infirmary
- Freeman Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ALLN-177
Arm Description
ALLN-177 7,500 units (2 capsules)
Outcomes
Primary Outcome Measures
Change in plasma oxalate
Efficacy will be assessed based on change from baseline in plasma oxalate
Secondary Outcome Measures
Change in 24-hr urinary oxalate excretion
Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion
Full Information
NCT ID
NCT03391804
First Posted
January 2, 2018
Last Updated
December 29, 2020
Sponsor
Allena Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT03391804
Brief Title
Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Official Title
Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
December 13, 2019 (Actual)
Study Completion Date
December 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allena Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteric Hyperoxaluria, Primary Hyperoxaluria, Hyperoxalemia
Keywords
Oxalate, Kidney Stones, oxalate nephropathy, systemic oxalosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALLN-177
Arm Type
Experimental
Arm Description
ALLN-177 7,500 units (2 capsules)
Intervention Type
Drug
Intervention Name(s)
ALLN-177
Other Intervention Name(s)
Oxalate decarboxylase
Intervention Description
ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks
Primary Outcome Measure Information:
Title
Change in plasma oxalate
Description
Efficacy will be assessed based on change from baseline in plasma oxalate
Time Frame
on 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Change in 24-hr urinary oxalate excretion
Description
Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion
Time Frame
on 12 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed a informed consent form or an assent
Aged 12 or older with body weight ≥ 35kg
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)
Urinary oxalate ≥ 40mg/24h (normalized for body surface area in children) at Screening in patients with eGFR >15 mL/min/1.73m2
In patients with enteric hyperoxaluria, eGFR < 45mL/min/1.73m2 at Screening
In patients with enteric hyperoxaluria, plasma oxalate > 5µmol/L at Screening
Patients on dialysis, must be stable for greater than 3 months
Exclusion Criteria:
1. Unable or unwilling to discontinue Vitamin C supplementation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Clark, MD
Organizational Affiliation
Allena Pharmaceuticals Inc
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Applied Research Center of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Wellcome Trust Clinical Research Facility
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7 DN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
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