Clinical trial NCT03391804: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Enteric Hyperoxaluria
Primary Hyperoxaluria
Hyperoxalemia
Keywords: Oxalate
Kidney Stones
oxalate nephropathy
systemic oxalosis
Lead sponsor: Allena Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2018-01-05
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in plasma oxalate
timeFrame: on 12 weeks of treatment
Secondary outcomes:
measure: Change in 24-hr urinary oxalate excretion
timeFrame: on 12 weeks of treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Berlin
country: Germany
facility: Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin
city: Southampton
country: United Kingdom
facility: Wellcome Trust Clinical Research Facility
state: Hampshire
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: Lancashire
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Allena Pharmaceuticals Inc
name: David Clark, MD
role: STUDY_DIRECTOR
References: