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

Primary Purpose

Hyperphosphatemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EOS789
Placebo
Renvela
Sponsored by
Chugai Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Period 1 Arm 1

Period 1 Arm 2

Period 2 Arm 1

Period 2 Arm 2

Arm Description

EOS789 Dose 1 in treatment sequence 1, Placebo in treatment sequence 2

Placebo in treatment sequence 1, EOS789 Dose 1 in treatment sequence 2

EOS789 Dose 2 in treatment sequence 1, EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 2

EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 1, EOS789 Dose 2 in treatment sequence 2

Outcomes

Primary Outcome Measures

Safety: Incidences of adverse events
Incidences of adverse events
Safety: Change from baseline in vital signs
Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate)
Safety: Change from baseline in clinical laboratory tests
Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation)
Safety: Change from baseline in 12 lead ECGs
Change from baseline in 12 lead ECGs

Secondary Outcome Measures

Pharmacokinetics: Plasma concentration of EOS789
Pharmacokinetics: Total exposure (area under the curve [AUC])
Pharmacokinetics: Maximum concentration (Cmax)
Pharmacokinetics: Time to reach Cmax (Tmax)
Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state
Pharmacodynamics: Intestinal fractional phosphorus absorption and accumulated fecal excretion of phosphorus
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

Full Information

First Posted
November 11, 2016
Last Updated
September 12, 2018
Sponsor
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT02965053
Brief Title
A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chugai Pharmaceutical

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Period 1 Arm 1
Arm Type
Experimental
Arm Description
EOS789 Dose 1 in treatment sequence 1, Placebo in treatment sequence 2
Arm Title
Period 1 Arm 2
Arm Type
Experimental
Arm Description
Placebo in treatment sequence 1, EOS789 Dose 1 in treatment sequence 2
Arm Title
Period 2 Arm 1
Arm Type
Experimental
Arm Description
EOS789 Dose 2 in treatment sequence 1, EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 2
Arm Title
Period 2 Arm 2
Arm Type
Experimental
Arm Description
EOS789 Dose 2 + Sevelamer carbonate in treatment sequence 1, EOS789 Dose 2 in treatment sequence 2
Intervention Type
Drug
Intervention Name(s)
EOS789
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Renvela
Other Intervention Name(s)
Sevelamer carbonate
Primary Outcome Measure Information:
Title
Safety: Incidences of adverse events
Description
Incidences of adverse events
Time Frame
Up to Day 42 in each treatment sequence
Title
Safety: Change from baseline in vital signs
Description
Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate)
Time Frame
Up to Day 42 in each treatment sequence
Title
Safety: Change from baseline in clinical laboratory tests
Description
Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation)
Time Frame
Up to Day 42 in each treatment sequence
Title
Safety: Change from baseline in 12 lead ECGs
Description
Change from baseline in 12 lead ECGs
Time Frame
Up to Day 42 in each treatment sequence
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Plasma concentration of EOS789
Time Frame
Day 4, 9, 10, 11 in the first treatment sequence in each period
Title
Pharmacokinetics: Total exposure (area under the curve [AUC])
Time Frame
Day 10 in the first treatment sequence in each period
Title
Pharmacokinetics: Maximum concentration (Cmax)
Time Frame
Day 10 in the first treatment sequence in each period
Title
Pharmacokinetics: Time to reach Cmax (Tmax)
Time Frame
Day 10 in the first treatment sequence in each period
Title
Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state
Time Frame
Day 9 in the first treatment sequence in each period
Title
Pharmacodynamics: Intestinal fractional phosphorus absorption and accumulated fecal excretion of phosphorus
Time Frame
Days 11 to 13 in the first treatment sequence and second treatment sequence in each period
Title
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
Time Frame
Day 13 in the first treatment sequence and second treatment sequence in each period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Leader
Organizational Affiliation
Chugai Pharmaceutical
Official's Role
Study Director
Facility Information:
City
Indianapolis
State/Province
Indiana
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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