Status:
COMPLETED
Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia
Lead Sponsor:
Allena Pharmaceuticals
Conditions:
Enteric Hyperoxaluria
Primary Hyperoxaluria
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 prim...
Eligibility Criteria
Inclusion
- 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
- 1\. Unable or unwilling to discontinue Vitamin C supplementation
Key Trial Info
Start Date :
July 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03391804
Start Date
July 17 2018
End Date
December 13 2019
Last Update
December 30 2020
Active Locations (9)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Applied Research Center of Arkansas
Little Rock, Arkansas, United States, 72212
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
4
Mayo Clinic
Rochester, Minnesota, United States, 55905