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

Chugai Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hyperphosphatemia

Treatments: Drug: EOS789; Drug: Placebo; Drug: Renvela

Study type: Interventional

Funder types: Industry

Identifiers

NCT02965053

EOS103US

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 4 patient groups

Period 1 Arm 1

Experimental group

Description:

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

Treatment:

Drug: EOS789

Drug: Placebo

Period 1 Arm 2

Experimental group

Description:

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

Treatment:

Drug: EOS789

Drug: Placebo

Period 2 Arm 1

Experimental group

Description:

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

Treatment:

Drug: EOS789

Drug: Renvela

Period 2 Arm 2

Experimental group

Description:

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

Treatment:

Drug: EOS789

Drug: Renvela