Enteric Hyperoxaluria
Conditions
Keywords
kidney stone, hyperoxaluria, enteric hyperoxaluria, oxalate, kidney calcification
Brief summary
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.
Detailed description
This is a phase 3, global, multi-center, randomized, double-blind, placebo-controlled study. This study is designed to determine the short- and long-term efficacy of reloxaliase in terms of reducing urinary oxalate excretion and clinical benefits compared to placebo.
Interventions
DRUGReloxaliase
Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
DRUGPlacebo
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day
Sponsors
Allena Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provided informed consent 2. Age 18 years or older 3. Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy) 4. Urinary oxalate ≥ 50 mg/24 hr 5. Has at least 1 documented kidney stone within 2 years
Exclusion criteria
1. Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30 mL/minute/1.73 m2 2. Has a known genetic, congenital, or other cause of kidney stones 3. Unable or unwilling to discontinue Vitamin C supplementation \>200mg daily 4. Cannot establish baseline kidney stone burden
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4 | 4 weeks | Efficacy will be assessed based on percent change from baseline to the average across Weeks 1 to 4, derived from all 24-hour collections during Weeks 1 to 4 on treatment |
| Proportion of subjects with kidney stone disease progression (composite of symptomatic kidney stone(s) or finding of new or enlarged kidney stone(s) on imaging) | up to 48 months | Efficacy will be assessed by comparing kidney stone disease progression event rate on reloxaliase vs. placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 16-24 | 24 weeks | Efficacy will be assessed based on percent change from baseline to the average across Weeks 16-24, derived from all 24-hour collections during Weeks 16-24 on treatment |
| Proportion of subjects with a ≥ 20% reduction from baseline in 24-hour urinary oxalate excretion during Weeks 1-4 | 4 weeks | Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the average across Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment |
| Hospitalizations or emergency room (ER) visits or procedures for the management of kidney stones | up to 48 months | Efficacy will be assessed by comparing utilization on reloxaliase vs. placebo |
| Change in estimated glomerular filtration rate (eGFR) from baseline | up to 48 months | Efficacy will be assessed by comparing the rate of change in eGFR on reloxaliase vs. placebo |
Countries
Austria, Belgium, Brazil, Canada, Croatia, France, Germany, Italy, Mexico, Portugal, Romania, Russia, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed