Completed

Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)

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What is being tested

Rilonacept

+ Placebo

Drug
Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 80 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 4
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorUniversity of Colorado, Denver
Last updated: September 12, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01663103
Principal SponsorUniversity of Colorado, Denver
Last updated: September 12, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesInflammationRenal Insufficiency, Chronic

Criteria

5 inclusion criteria required to participate
Ability to provide informed consent
Age 18-80 years
An elevated high sensitivity C-reactive protein (hs-CRP) of > 2.0 mg/L and < 30 mg/L on at least 2 consecutive weekly determinations
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)
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21 exclusion criteria prevent from participating
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
A history of active TB within the last 3 years even if it was treated
Active infection (chronic or acute (within 3 months) or antibiotic therapy (w/in 1 mo); history of recurrent infection
Alcohol dependence or abuse
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
12 weeks of treatment with rilonacept

Group II

Placebo
Twelve weeks of treatment with placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

University of Colorado Clinical and Translational Research Center (CTRC) Outpatient Clinic

Aurora, United StatesOpen University of Colorado Clinical and Translational Research Center (CTRC) Outpatient Clinic in Google Maps

Vanderbilt University Medical Center

Nashville, United States
Completed2 Study Centers