drugset / Trial / NCT03456830
Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.
Timeline
- Start
- 2018-05-21
- Primary completion
- 2019-09-30
- Completion
- 2019-10-28
Outcome
Met primary endpoint
paper 22.6% reduction in geometric mean UOx during weeks 1 to 4 for reloxaliase and 9.7% for placebo PMID 38319254 ↗
paper a difference of 14.3 percentage points (95% confidence interval [CI], 4.9 to 22.8; P=0.004). PMID 38319254 ↗
Publications
- Background Langman CB, Grujic D, Pease RM, Easter L, Nezzer J, Margolin A, Brettman L. A Double-Blind, Placebo Controlled, Randomized Phase 1 Cross-Over Study with ALLN-177, an Orally Administered Oxalate Degrading Enzyme. Am J Nephrol. 2016;44(2):150-8. doi: 10.1159/000448766. Epub 2016 Aug 17.
- Lieske JC, Lingeman JE, Ferraro PM, Wyatt CM, Tosone C, Kausz AT, Knauf F. Randomized Placebo-Controlled Trial of Reloxaliase in Enteric Hyperoxaluria. NEJM Evid. 2022 Jul;1(7):EVIDoa2100053. doi: 10.1056/EVIDoa2100053. Epub 2022 May 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Reloxaliase | Protein / enzyme biologic | 7500 iu | Oral |
Indications
No indication recorded.