Phase 4
N=42
Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)
Renal Insufficiency, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01663103 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: Change in Flow-mediated Dilation (FMD) — 1.1; -0.9 change in percent flow-mediated dilation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rilonacept (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Flow-mediated Dilation (FMD) |
1.1; -0.9 | — |
| SECONDARY Change in Aortic Pulse-wave Velocity (aPWV) |
12; 2 | — |
| SECONDARY Change in Contribution of Oxidative Stress to FMD |
0.16; 0.51; -0.04; 0.69 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-80 years
- CKD stage III or IV (eGFR with the 4-variable Modified Diet Renal Disease (MDRD) prediction equation: 15-60 mL/min/1.73m2; stable renal function in the past 3 months)
- An elevated high sensitivity C-reactive protein (hs-CRP) of > 2.0 mg/L and 40 kg/m2
- Warfarin use (or other cytochrome P (CYP)450 substrates with a narrow therapeutic index) [ok if do not participate in endothelial cell collection]
- Taking medication(s) that interact with agents administered during experimental sessions (e.g., sildenafil interacts with nitroglycerin)
- Currently receiving or planning to receive live or inactivated vaccines
- Alcohol dependence or abuse
- Subjects at risk for tuberculosis (TB). Specifically, subjects with:
- Current clinical, radiographic or laboratory evidence of active TB at screening or latent TB that has not been previously treated
- A history of active TB within the last 3 years even if it was treated.
- A history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type.
- Therapy for latent TB which has not been completed as per local guidelines.
Data sourced from ClinicalTrials.gov (NCT01663103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.