Trials / Completed
CompletedNCT02965053
A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
A Single-center, Randomized, 2-Period, Crossover, Study to Explore The Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Chugai Pharmaceutical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized study designed as a 2x2 cross-over in two periods (Period 1 and Period 2) to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of EOS789 in patients with chronic kidney disease (CKD) and hyperphosphatemia receiving hemodialysis. Period 1 is double-blind and Period 2 is open-label. Period 1 and Period 2 are identical with regard to the design, inclusion/exclusion criteria, and assessments. EOS789 and its combination with sevelamer carbonate are tested in Period 1 and Period 2 respectively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EOS789 | |
| DRUG | Placebo | |
| DRUG | Renvela |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2016-11-16
- Last updated
- 2018-09-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02965053. Inclusion in this directory is not an endorsement.