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

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

Study Overview

• Status: Completed
• Conditions: Enteric Hyperoxaluria; Primary Hyperoxaluria; Hyperoxalemia
• Intervention / Treatment: Drug: ALLN-177

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charite Campus Berlin-Mitte, Medizinische Klinik mit Schwepunkt Nephrologie und Internistische Intensivmedizin
• United Kingdom
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • Newcastle, United Kingdom, NE7 7 DN
    • Freeman Hospital
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Wellcome Trust Clinical Research Facility
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR2 9HT
      • Royal Preston Hospital
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Applied Research Center of Arkansas
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School of Medicine
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALLN-177; ALLN-177 7,500 units (2 capsules)	Drug: ALLN-177; ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks; Other Names: Oxalate decarboxylase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in plasma oxalate	Efficacy will be assessed based on change from baseline in plasma oxalate	on 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Allena Pharmaceuticals
• Investigators: Study Director: David Clark, MD, Allena Pharmaceuticals Inc

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): December 13, 2019
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: January 2, 2018
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 30, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Kidney Stones; Oxalate; oxalate nephropathy; systemic oxalosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Genetic Diseases, Inborn; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Hyperoxaluria; Hyperoxaluria, Primary
• Other Study ID Numbers: ALLN-177-206; 2017-003547-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No