Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1632
Source ID: NCT02965053
Associated Drug: Eos789
Title: A Phase1 Study to Explore the Safety of EOS789 in Patients With Chronic Kidney Disease and Hyperphosphatemia on Hemodialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hyperphosphatemia
Interventions: DRUG: EOS789|DRUG: Placebo|DRUG: Renvela
Outcome Measures: Primary: 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: 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|Pharmacodynamics: Intestinal fractional phosphorus absorption and accumulated fecal excretion of phosphorus, Days 11 to 13 in the first treatment sequence and second treatment sequence in each period|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, Day 13 in the first treatment sequence and second treatment sequence in each period
Sponsor/Collaborators: Sponsor: Chugai Pharmaceutical
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-12
Completion Date: 2018-08
Results First Posted:
Last Update Posted: 2018-09-13
Locations: Indianapolis, Indiana, United States
URL: https://clinicaltrials.gov/show/NCT02965053