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NCT Number: NCT03391804

Study of ALLN-177 in Patients 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

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Key information

Conditions

Enteric Hyperoxaluria Calculi Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Hyperoxalemia Hyperoxaluria Hyperoxaluria, Primary Kidney Calculi Kidney Diseases Male Urogenital Diseases Metabolic Diseases Metabolism, Inborn Errors Nephrolithiasis Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Primary Hyperoxaluria Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Unable or unwilling to discontinue Vitamin C supplementation

Treatment and study plan

ALLN-177

Drug

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

Other names: Oxalate decarboxylase

Primary outcomes

  1. Change in plasma oxalate

    Time frame: on 12 weeks of treatment

    Efficacy will be assessed based on change from baseline in plasma oxalate

Secondary outcomes

  1. Change in 24-hr urinary oxalate excretion

    Time frame: on 12 weeks of treatment

    Efficacy will be assessed based on change from baseline in 24-hr urinary oxalate excretion

Sponsors and collaborators

Lead sponsor

Allena Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2018
Registry last updated
Dec 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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