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

Phase 2

Completed

• Conditions: Hyperoxalemia; Enteric Hyperoxaluria; Primary Hyperoxaluria
• Interventions: Drug: ALLN-177

• Registration Number: NCT03391804
• Lead Sponsor: Allena Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-04
• Study First Posted: 2018-01-05
• Study Start: 2018-07-17
• Primary Completion: 2019-12-13
• Study Completion: 2019-12-13
• Status Verified: 2020-02
• Last Update Submitted: 2020-12-29
• Last Update Posted: 2020-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALLN-177	ALLN-177	ALLN-177 7,500 units (2 capsules)

Primary Outcome Measures

Name	Time	Method
Change in plasma oxalate	on 12 weeks of treatment	Efficacy will be assessed based on change from baseline in plasma oxalate

Secondary Outcome Measures

Name	Time	Method
Change in 24-hr urinary oxalate excretion	on 12 weeks of treatment	Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion

Trial Locations

Locations (8)

Wellcome Trust Clinical Research Facility; 🇬🇧 Southampton, Hampshire, United Kingdom

Royal Preston Hospital; 🇬🇧 Preston, Lancashire, United Kingdom

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom

Applied Research Center of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin; 🇩🇪 Berlin, Germany

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States