Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

Primary Hyperoxaluria Clinical Trial

Official title:

Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391804
• Other study ID #: ALLN-177-206
• Secondary ID: 2017-003547-38
• Status: Completed
• Phase: Phase 2
• Start date: July 17, 2018
• Est. completion date: December 13, 2019

Study information

• Verified date: February 2020
• Source: Allena Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 13, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enteric Hyperoxaluria
• Hyperoxalemia
• Hyperoxaluria, Primary
• Primary Hyperoxaluria

Intervention

Drug:
• ALLN-177
ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks

Locations

Country	Name	City	State
Germany	Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin	Berlin
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Royal Preston Hospital	Preston	Lancashire
United Kingdom	Wellcome Trust Clinical Research Facility	Southampton	Hampshire
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Allena Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma oxalate	Efficacy will be assessed based on change from baseline in plasma oxalate	on 12 weeks of treatment
Secondary	Change in 24-hr urinary oxalate excretion	Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion	on 12 weeks of treatment