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

NCT02965053 | Completed Phase 1

• 1 other identifier: EOS103US
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (4)

• Safety: Incidences of adverse events

  Incidences of adverse events

  Up to Day 42 in each treatment sequence

• 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

• 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

• Safety: Change from baseline in 12 lead ECGs

  Change from baseline in 12 lead ECGs

  Up to Day 42 in each treatment sequence

Secondary Outcomes (7)

• 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

Study Arms (4)

Period 1 Arm 1

EXPERIMENTAL

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

Drug: EOS789; Drug: Placebo

Period 1 Arm 2

EXPERIMENTAL

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

Drug: EOS789; Drug: Placebo

Period 2 Arm 1

EXPERIMENTAL

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

Drug: EOS789; Drug: Renvela

Period 2 Arm 2

EXPERIMENTAL

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

Drug: EOS789; Drug: Renvela

Interventions

EOS789 DRUG

Period 1 Arm 1; Period 1 Arm 2; Period 2 Arm 1; Period 2 Arm 2

Placebo DRUG

Period 1 Arm 1; Period 1 Arm 2

Renvela DRUG

Also known as: Sevelamer carbonate

Period 2 Arm 1; Period 2 Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

Study Sites (1)

Unknown Facility

Indianapolis, Indiana, United States

Location

MeSH Terms

Conditions

Hyperphosphatemia

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Study Officials

• Clinical Leader

  Chugai Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 16, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

US (1)