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Clinical Trial Details

Trial ID: L0464
Source ID: NCT03160430
Associated Drug: Apabetalone
Title: A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis
Acronym:
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic
Interventions: DRUG: apabetalone|DRUG: Placebos
Outcome Measures: Primary: Percent change in alkaline phosphatase (ALP) concentration (Part B), The primary endpoint of the study is the comparison of the RVX000222 treatment period to the placebo period in the percent change in ALP concentration. Percent change is computed relative to the beginning of each period., Percent change is computed relative to the beginning of each period (6 weeks)|Single Dose Cmax of RVX000222 (apabetalone) and the Metabolites RVX000288 and RVX000404, Primary PK comparison between dialysis (test) and non-dialysis (reference) days for Cmax of RVX000222 and its two principal metabolites, RVX000288 and RVX000404, 48 hours|Single Dose AUC of RVX000222 (apabetalone) and the Metabolites RVX000288 and RVX000404, Primary PK comparison between dialysis (test) and non-dialysis (reference) days for AUC of RVX000222 and its two principal metabolites, RVX000288 and RVX000404, 48 hours | Secondary: Changes in high-sensitivity C-Reactive Protein (hsCRP), Changes in hsCRP in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks|Changes in Interleukin-13 (IL-13), Changes in IL-13 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks|Changes in Interleukin-6 (IL-6), Changes in IL-6 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks|Changes in Interleukin-8 (IL-8), Changes in IL-8 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks|Changes in Monocyte Chemoattractant Protein-1 (MCP-1), Changes in MCP-1 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks|Change in key markers of vascular mineralization, Change in key markers of vascular mineralization i.e. RANKL and osteoprotegerin at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks|Changes in ALP isoenzymes, Changes in ALP isoenzymes at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks|Changes in Parathyroid hormone (PTH), Changes in parathyroid hormone at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks|Change in apolipoprotein A1 (apoA-I), HDL-C, LDL-C, apolipoprotein B (apoB), and triglycerides, Change in apoA-I, HDL-C, LDL-C, apoB, and triglycerides at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks|Change in Analyzing Data, Recognizing Excellence and Optimizing Outcomes All-Cause Mortality Risk Score For Patients on Chronic Hemodialysis (ARO Score), Change in ARO Score at the end of the RVX000222 treatment period relative to the end of the placebo period, 6 weeks
Sponsor/Collaborators: Sponsor: Resverlogix Corp
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 44
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-11-22
Completion Date: 2026-11-22
Results First Posted:
Last Update Posted: 2023-11-15
Locations:
URL: https://clinicaltrials.gov/show/NCT03160430