A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis

Hyperphosphatemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965053
• Other study ID #: EOS103US
• Status: Completed
• Phase: Phase 1
• Start date: December 2016
• Est. completion date: August 2018

Study information

• Verified date: September 2018
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• EOS789

• Placebo

• Renvela

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidences of adverse events	Incidences of adverse events	Up to Day 42 in each treatment sequence
Primary	Safety: Change from baseline in vital signs	Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate)	Up to Day 42 in each treatment sequence
Primary	Safety: Change from baseline in clinical laboratory tests	Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation)	Up to Day 42 in each treatment sequence
Primary	Safety: Change from baseline in 12 lead ECGs	Change from baseline in 12 lead ECGs	Up to Day 42 in each treatment sequence
Secondary	Pharmacokinetics: Plasma concentration of EOS789		Day 4, 9, 10, 11 in the first treatment sequence in each period
Secondary	Pharmacokinetics: Total exposure (area under the curve [AUC])		Day 10 in the first treatment sequence in each period
Secondary	Pharmacokinetics: Maximum concentration (Cmax)		Day 10 in the first treatment sequence in each period
Secondary	Pharmacokinetics: Time to reach Cmax (Tmax)		Day 10 in the first treatment sequence in each period
Secondary	Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state		Day 9 in the first treatment sequence in each period
Secondary	Pharmacodynamics: Intestinal fractional phosphorus absorption and accumulated fecal excretion of phosphorus		Days 11 to 13 in the first treatment sequence and second treatment sequence in each period
Secondary	Efficacy: Change from baseline of serum phosphorus (P), Calcium (Ca), Ca x P, intact parathyroid hormone (PTH), and fibroblast growth factor (FGF23) at Day 13		Day 13 in the first treatment sequence and second treatment sequence in each period