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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperphosphatemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Period 1 Arm 1

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

Group Type EXPERIMENTAL

EOS789

Intervention Type DRUG

Placebo

Intervention Type DRUG

Period 1 Arm 2

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

Group Type EXPERIMENTAL

EOS789

Intervention Type DRUG

Placebo

Intervention Type DRUG

Period 2 Arm 1

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

Group Type EXPERIMENTAL

EOS789

Intervention Type DRUG

Renvela

Intervention Type DRUG

Period 2 Arm 2

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

Group Type EXPERIMENTAL

EOS789

Intervention Type DRUG

Renvela

Intervention Type DRUG

Interventions

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EOS789

Intervention Type DRUG

Placebo

Intervention Type DRUG

Renvela

Intervention Type DRUG

Other Intervention Names

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Sevelamer carbonate

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No