Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01537315 · ClinicalTrials.gov registry record · Phase 2
Hydroxychloroquine in Cardiovascular Disease in Patients With Chronic Kidney Disease: A Proof of Concept Study
A Phase 2 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01537315: Clinical Trial Phase 2 study, sponsored by University of Arkansas.
NCT01537315 is a Phase 2 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01537315, a Phase 2 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Presence of multiple traditional and nontraditional risk factors of atherosclerosis and cardiovascular disease (CVD) including inflammation in patients with chronic kidney disease (CKD) contribute to high CVD morbidity and mortality in this patient population. Additionally, the traditional approaches towards the therapy of CVD have little impact on CV mortality in these patients. Hydroxychloroquine (HCQ) used as anti-inflammatory in rheumatological disorders, has multiple beneficial properties relevant to the process of vascular disease. The effects of HCQ on atherosclerosis (AS) and vascular disease in CKD is not known yet. Thus, the study hypothesis is that HCQ treatment in individuals with CKD will provide clinically significant benefit in the management of CVD and will provide biological and functional atherosclerotic benefits.
Primary Outcome
Hs-CRP will be measured at baseline (before study drug) and at end of study (6 months). This marker is measured by ELISA assay from serum.
Interventions
- OTHER Matching Placebo
- DRUG Hydroxychloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
Why NCT01537315 stopped before completion
NCT01537315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT01537315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01537315 about?
NCT01537315 is a clinical study titled "Hydroxychloroquine in Cardiovascular Disease in Patients With Chronic Kidney Disease: A Proof of Concept Study". Presence of multiple traditional and nontraditional risk factors of atherosclerosis and cardiovascular disease (CVD) including inflammation in patients with chronic kidney disease (CKD) contribute to high CVD morbidity and mortality in this patient population. Additionally, the traditional approache...
What is the current status of trial NCT01537315?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2012-02. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01537315?
The interventions under investigation include: Matching Placebo (OTHER), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT01537315?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01537315's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia