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NCT01663103 · ClinicalTrials.gov registry record · Phase 4
Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
NCT01663103: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT01663103 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 42 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01663103, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
Study Summary
Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a key mechanism contributing to vascular dysfunction (i.e., large elastic artery stiffening and endothelial dysfunction). Inhibiting inflammation improves vascular dysfunction in other populations characterized by chronic inflammation. However, it is currently unknown if reducing inflammation with an interleukin-1 (IL-1) blocker enhances vascular function in CKD patients. Aim 1 will assess the efficacy of IL-1 blocking with rilonacept for treating vascular dysfunction in patients with stage III or IV CKD (estimated glomerular filtration rate 15-60 mL/min/1.73 m2). Aim 2 will determine if blocking IL-1 with rilonacept also reduces inflammation and oxidative stress. These studies could shift clinical practice guidelines by establishing a novel therapy for reducing CVD risk in CKD patients not requiring chronic hemodialysis.
Primary Outcome
Change in FMD after 3 months of treatment with rilonacept will be compared to change in the placebo group.
Interventions
- DRUG Placebo
- DRUG Rilonacept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01663103 record still lists
NCT01663103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01663103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01663103 about?
NCT01663103 is a clinical study titled "Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)". Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a key mechanism contributing to vascular...
What is the current status of trial NCT01663103?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2012-08. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01663103?
The interventions under investigation include: Placebo (DRUG), Rilonacept (DRUG).
Who is sponsoring clinical trial NCT01663103?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01663103's enrollment target sits among peer trials
42 1380th of 2000 higher than 611 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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