Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
2 other identifiers
interventional
15
3 countries
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2018
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 2, 2018
CompletedFirst Posted
Study publicly available on registry
January 5, 2018
CompletedStudy Start
First participant enrolled
July 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2019
CompletedDecember 30, 2020
February 1, 2020
1.4 years
January 2, 2018
December 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in plasma oxalate
Efficacy will be assessed based on change from baseline in plasma oxalate
on 12 weeks of treatment
Secondary Outcomes (1)
Change in 24-hr urinary oxalate excretion
on 12 weeks of treatment
Study Arms (1)
ALLN-177
EXPERIMENTALALLN-177 7,500 units (2 capsules)
Interventions
ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. Unable or unwilling to discontinue Vitamin C supplementation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin
Berlin, 10117, Germany
Wellcome Trust Clinical Research Facility
Southampton, Hampshire, SO16 6YD, United Kingdom
Royal Preston Hospital
Preston, Lancashire, PR2 9HT, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Freeman Hospital
Newcastle, NE7 7 DN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Clark, MD
Allena Pharmaceuticals Inc
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2018
First Posted
January 5, 2018
Study Start
July 17, 2018
Primary Completion
December 13, 2019
Study Completion
December 13, 2019
Last Updated
December 30, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share