A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/15/2018 |
| Start Date: | December 2016 |
| End Date: | August 2018 |
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
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.
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.
Inclusion Criteria:
- Patients with CKD and hyperphosphatemia must meet the following criteria for study entry:
- Age ≥18 years
- On thrice-weekly hemodialysis for at least 3 months prior to screening
- Not having changed dialysis prescription within 4 weeks prior to screening for
dialyzer, calcium concentration in dialysate, or dry weight more than 1 kg
- Receiving stable doses of treatments affecting serum phosphorus for at least 4 weeks
prior to screening and willing to discontinue these treatments
Exclusion Criteria:
－ Patients with CKD and hyperphosphatemia who meet any of the following criteria will be
excluded from study entry:
- Uncontrolled diabetes and/or hypertension in the opinion of the investigators
- Uncontrolled chronic constipation and/or diarrhea in the opinion of the investigators
- Hospitalization for cardiac disease in previous 3 months
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper
limit of normal (ULN)
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