drugset / Trial / NCT03847090
Establishing the Safety and Efficacy of Reloxaliase in Patients With Enteric Hyperoxaluria
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine the efficacy, durability and long-term safety of reloxaliase in patients with enteric hyperoxaluria.
Timeline
- Start
- 2019-08-26
- Primary completion
- 2022-05-19
- Completion
- 2022-05-19
Outcome
Outcome not reported
Stopped: “Interim Analysis -”
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.
- Background Lingeman JE, Pareek G, Easter L, Pease R, Grujic D, Brettman L, Langman CB. ALLN-177, oral enzyme therapy for hyperoxaluria. Int Urol Nephrol. 2019 Apr;51(4):601-608. doi: 10.1007/s11255-019-02098-1. Epub 2019 Feb 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Reloxaliase | Protein / enzyme biologic | 142 mg | Oral |
Indications
No indication recorded.