A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
Completed · Phase 1 · Has a placebo group
Conditions studied: Hyperphosphatemia
In brief
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.
Key facts
- Study ID
- NCT02965053
- Run by
- Chugai Pharmaceutical
- People needed
- 26
- Starts
- 2016-12-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2018-09-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Study site — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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