Trial · NCT03160430
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change in alkaline phosphatase (ALP) concentration (Part B) | Percent change is computed relative to the beginning of each period (6 weeks) | 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. |
| Primary | Single Dose Cmax of RVX000222 (apabetalone) and the Metabolites RVX000288 and RVX000404 | 48 hours | Primary PK comparison between dialysis (test) and non-dialysis (reference) days for Cmax of RVX000222 and its two principal metabolites, RVX000288 and RVX000404 |
| Primary | Single Dose AUC of RVX000222 (apabetalone) and the Metabolites RVX000288 and RVX000404 | 48 hours | Primary PK comparison between dialysis (test) and non-dialysis (reference) days for AUC of RVX000222 and its two principal metabolites, RVX000288 and RVX000404 |
| Secondary | Changes in high-sensitivity C-Reactive Protein (hsCRP) | 6 weeks | Changes in hsCRP in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period |
| Secondary | Changes in Interleukin-13 (IL-13) | 6 weeks | Changes in IL-13 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period |
| Secondary | Changes in Interleukin-6 (IL-6) | 6 weeks | Changes in IL-6 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period |
| Secondary | Changes in Interleukin-8 (IL-8) | 6 weeks | Changes in IL-8 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period |
| Secondary | Changes in Monocyte Chemoattractant Protein-1 (MCP-1) | 6 weeks | Changes in MCP-1 in dialysis patients at the end of the RVX000222 treatment period relative to the end of the placebo period |
| Secondary | Change in key markers of vascular mineralization | 6 weeks | 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 |
| Secondary | Changes in ALP isoenzymes | 6 weeks | Changes in ALP isoenzymes at the end of the RVX000222 treatment period relative to the end of the placebo period |
| Secondary | Changes in Parathyroid hormone (PTH) | 6 weeks | Changes in parathyroid hormone at the end of the RVX000222 treatment period relative to the end of the placebo period |
| Secondary | Change in apolipoprotein A1 (apoA-I), HDL-C, LDL-C, apolipoprotein B (apoB), and triglycerides | 6 weeks | 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 |
| Secondary | Change in Analyzing Data, Recognizing Excellence and Optimizing Outcomes All-Cause Mortality Risk Score For Patients on Chronic Hemodialysis (ARO Score) | 6 weeks | Change in ARO Score at the end of the RVX000222 treatment period relative to the end of the placebo period |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03160430/registered