Status:
COMPLETED
Inflammation, Proteolysis and IL-1 Beta Receptor Inhibition in Chronic Hemodialysis Patients
Lead Sponsor:
Vanderbilt University
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Chronic hemodialysis (CHD) patients display multiple metabolic abnormalities related to advanced uremia. Despite vigorous attempts to prevent these abnormalities and their consequences, most CHD patie...
Eligibility Criteria
Inclusion
- Patients on CHD for more than 3 months;
- Ability to read and sign the consent form;
- Have acceptable dialysis adequacy (Kt/V \> 1.2);
- Use biocompatible hemodialysis membrane;
- Have a patent, well functioning, arteriovenous dialysis access;
- Signs of chronic inflammation (the average of three consecutive CRP measurements ≥ 5 mg/L).
Exclusion
- Patients with residual renal function \> 5 ml/min or urine output \> 100 ml/day;
- Pregnancy;
- Intolerance to the study medication or contraindication to the study medication: Hypersensitivity to E. coli-derived proteins, anakinra, or any component of the formulation; patients with active infections (including chronic or local infection);
- Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer or cancer history in the prior 5 years, HIV, liver disease including positive test or history of Hepatitis B or C);
- Hospitalization within 1 month prior to the study;
- Malfunctioning arterial-venous vascular access \[recirculation and/or blood flow \< 500 ml/min for an arterial-venous graft (AVG) or \< 400 ml/min for an arterial-venous fistula (AVF)\];
- Patients receiving steroids and/or other immunosuppressive agents;
- Life-expectancy less than 6 months;
- Age greater than 75 or less than 18 years old;
- Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin.
- Presence of active infections or a history of pulmonary TB infection with or without documented adequate therapy. Subjects with current active TB, or recent close exposure to an individual with active TB, are excluded from the study.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00420290
Start Date
January 1 2008
End Date
May 1 2010
Last Update
November 17 2011
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232