TerminatedPhase 3

Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria

Stopped: Interim Analysis -

United States92 participantsStarted 2019-08-26

Plain-language summary

The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Provided informed consent
✓. Age 18 years or older
✓. Has an underlying enteric disorder associated with malabsorption with known or suspected history of hyperoxaluria (e.g., history of kidney stones or oxalate nephropathy)
✓. Urinary oxalate ≥ 50 mg/24 hr
✓. Has at least 1 documented kidney stone within 2 years

Exclusion criteria

✕. Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30 mL/minute/1.73 m2
✕. Has a known genetic, congenital, or other cause of kidney stones
✕. Unable or unwilling to discontinue Vitamin C supplementation \>200mg daily
✕. Cannot establish baseline kidney stone burden

What they're measuring

Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1 to 4

Timeframe: 4 weeks

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)

Timeframe: up to 48 months

Trial details

NCT IDNCT03847090

SponsorAllena Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-19

View on ClinicalTrials.gov More Enteric Hyperoxaluria trials