drugset / Trial / NCT02081534
Dose Finding Study to Treat High Phosphate Levels in the Blood.
RandomizedParallel-groupDouble-blindTreatment
Summary
Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period
Timeline
- Start
- 2014-03
- Primary completion
- 2014-11
- Completion
- 2014-11
Outcome
Met primary endpoint
registry analysis (superiority test); 1 mg Bid vs 3 mg Bid vs 10 mg Bid vs 30 mg Bid vs 3 mg od vs 30 mg od vs Placebo; p = 0.012; ANCOVA NCT02081534 ↗
release “AstraZeneca's 161-patient Phase 2b clinical trial evaluating tenapanor in hyperphosphatemic patients with chronic kidney disease on hemodialysis met its primary endpoint” ardelyx.com ↗
Publications
- Sprague SM, Weiner DE, Tietjen DP, Pergola PE, Fishbane S, Block GA, Silva AL, Fadem SZ, Lynn RI, Fadda G, Pagliaro L, Zhao S, Edelstein S, Spiegel DM, Rosenbaum DP. Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study. Kidney360. 2024 May 1;5(5):732-742. doi: 10.34067/KID.0000000000000387. Epub 2024 Feb 7.
- Block GA, Rosenbaum DP, Yan A, Greasley PJ, Chertow GM, Wolf M. The effects of tenapanor on serum fibroblast growth factor 23 in patients receiving hemodialysis with hyperphosphatemia. Nephrol Dial Transplant. 2019 Feb 1;34(2):339-346. doi: 10.1093/ndt/gfy061.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tenapanor | Small molecule | 1 mg | Oral |
| Subject | Tenapanor | Small molecule | 3 mg | Oral |
| Subject | Tenapanor | Small molecule | 10 mg | Oral |
| Subject | Tenapanor | Small molecule | 30 mg | Oral |