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NCT Number: NCT02965053

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

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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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

EOS789

Drug

Placebo

Drug

Renvela

Drug

Other names: Sevelamer carbonate

Primary outcomes

  1. Safety: Incidences of adverse events

    Time frame: Up to Day 42 in each treatment sequence

    Incidences of adverse events

  2. Safety: Change from baseline in vital signs

    Time frame: Up to Day 42 in each treatment sequence

    Change from baseline in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate)

  3. Safety: Change from baseline in clinical laboratory tests

    Time frame: Up to Day 42 in each treatment sequence

    Change from baseline in clinical laboratory tests (hematology, biochemistry, coagulation)

  4. Safety: Change from baseline in 12 lead ECGs

    Time frame: Up to Day 42 in each treatment sequence

    Change from baseline in 12 lead ECGs

Secondary outcomes

  1. Pharmacokinetics: Plasma concentration of EOS789

    Time frame: Day 4, 9, 10, 11 in the first treatment sequence in each period

  2. Pharmacokinetics: Total exposure (area under the curve [AUC])

    Time frame: Day 10 in the first treatment sequence in each period

  3. Pharmacokinetics: Maximum concentration (Cmax)

    Time frame: Day 10 in the first treatment sequence in each period

  4. Pharmacokinetics: Time to reach Cmax (Tmax)

    Time frame: Day 10 in the first treatment sequence in each period

  5. Pharmacokinetics: Removal ratio of EOS789 by hemodialysis at steady state

    Time frame: Day 9 in the first treatment sequence in each period

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2016
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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