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

Sponsor

Chugai Pharmaceutical (Industry)

Overall Status

Completed

CT.gov ID

NCT02965053

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hyperphosphatemia	Drug: EOS789 Drug: Placebo Drug: Renvela	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Period 1 Arm 1 EOS789 Dose 1 in treatment sequence 1, Placebo in treatment sequence 2	Drug: EOS789 Drug: Placebo
Experimental: Period 1 Arm 2 Placebo in treatment sequence 1, EOS789 Dose 1 in treatment sequence 2	Drug: EOS789 Drug: Placebo
Experimental: Period 2 Arm 1 EOS789 Dose 2 in treatment sequence 1, EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 2	Drug: EOS789 Drug: Renvela Other Names: Sevelamer carbonate
Experimental: Period 2 Arm 2 EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 1, EOS789 Dose 2 in treatment sequence 2	Drug: EOS789 Drug: Renvela Other Names: Sevelamer carbonate

Outcome Measures

Primary Outcome Measures

Safety: Incidences of adverse events [Up to Day 42 in each treatment sequence]
Incidences of adverse events
Safety: Change from baseline in vital signs [Up to Day 42 in each treatment sequence]
Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate)
Safety: Change from baseline in clinical laboratory tests [Up to Day 42 in each treatment sequence]
Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation)
Safety: Change from baseline in 12 lead ECGs [Up to Day 42 in each treatment sequence]
Change from baseline in 12 lead ECGs

Secondary Outcome Measures

Pharmacokinetics: Plasma concentration of EOS789 [Day 4, 9, 10, 11 in the first treatment sequence in each period]
Pharmacokinetics: Total exposure (area under the curve [AUC]) [Day 10 in the first treatment sequence in each period]
Pharmacokinetics: Maximum concentration (Cmax) [Day 10 in the first treatment sequence in each period]
Pharmacokinetics: Time to reach Cmax (Tmax) [Day 10 in the first treatment sequence in each period]
Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state [Day 9 in the first treatment sequence in each period]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Indianapolis	Indiana	United States

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Director: Clinical Leader, Chugai Pharmaceutical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chugai Pharmaceutical

ClinicalTrials.gov Identifier:

NCT02965053

Other Study ID Numbers:

EOS103US

First Posted:

Nov 16, 2016

Last Update Posted:

Sep 13, 2018

Last Verified:

Sep 1, 2018

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Hyperphosphatemia

Sevelamer

Study Results

No Results Posted as of Sep 13, 2018