A Phase 3 interventional study of ALLN-177 and Placebo in Enteric Hyperoxaluria, sponsored by Allena Pharmaceuticals. Completed at 63 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-27.
Sponsored by Allena Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.
Exclusion Criteria:
ALLN-177 3,750 units per capsule
Drug: ALLN-177
Placebo capsule
Drug: Placebo
ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days
Also known as: Oxalate decarboxylase
Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days
Percent change from baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Efficacy will be assessed based on percent change from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
Time frame: 4 weeks
Proportion of subjects with a ≥ 20% reduction from Baseline in 24-hour urinary oxalate excretion during Weeks 1-4
Efficacy will be assessed based on proportion of subjects with ≥ 20% reduction from baseline to the mean of Weeks 1-4, derived from all 24-hour collections during Weeks 1-4 on treatment
Time frame: 4 weeks
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Allena Pharmaceuticals