Trial · NCT03160430
A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis
NCT03160430, Phase 1, Phase 2, Not yet recruiting, Resverlogix Corp
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis. Trials, record NCT03160430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03160430
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Two-Part Phase 2a Study of RVX000222 in Patients With End-Stage Renal Disease Treated With Hemodialysis
- NCT number
- NCT03160430
- Status
- Not yet recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 44 participants, estimated
- Lead sponsor
- Resverlogix Corp
- Conditions
- Kidney Failure, Chronic
- Interventions
- apabetalone, Placebos
- First posted
- 2017-05-19
- Last updated
- 2023-11-15
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03160430
GET https://conductscience.org/api/trials/v1/NCT03160430/registered