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Clinical Trial Details

Trial ID: L0698
Source ID: NCT05285787
Associated Drug: Epn-701 (Oral)
Title: A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT05285787/results
Conditions: End-Stage Renal Disease (ESRD)
Interventions: DRUG: EPN-701 (Oral)
Outcome Measures: Primary: Number of Participants With Adverse Events (AEs), Number of Participants with: Treatment-emergent AEs Treatment-emergent AEs assessed as related to the study drug. Serious Adverse Events Deaths, Through study completion; over 14 days treatment and one week follow up. | Secondary: Plasma Concentrations of EPN-701., • Maximum plasma concentration of EPN-701 (Cmax) \[ng/mL\]., Through study completion; over 14 days treatment and one week follow-up.|Time to Maximum Plasma Concentration of EPN-701., Time to maximum plasma concentration of EPN-701 (Tmax) (h)., Through study completion; over 14 days treatment and one week follow-up. | Other: Change From Baseline to Day 15 in Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L)., The percent change in circulating biomarker: Undercarboxylated MGP (pmol/L) levels from Day 1 (Baseline) to Day 15 was measured., Day 1 to Day 15|Change From Baseline to Day 22 in Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L)., The percent change in circulating biomarker: Undercarboxylated MGP (pmol/L) levels from Day 1 (Baseline) to Day 22 was measured., Day 1 to Day 22|Mean Value of Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L) at Day 22., The mean value of circulating biomarker: Undercarboxylated MGP (pmol/L) levels on Day 22 was measured., Day 22|Mean Measure of Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L)., Mean value of circulating biomarker: Undercarboxylated MGP (pmol/L) levels on Day 15 was measured., Day 15
Sponsor/Collaborators: Sponsor: Epizon Pharma, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-03-01
Completion Date: 2021-04-30
Results First Posted: 2024-09-25
Last Update Posted: 2024-09-25
Locations: Southeastern Clinical Research Institute, LLC, Augusta, Georgia, 30904, United States
URL: https://clinicaltrials.gov/show/NCT05285787