Status:
COMPLETED
Inflammation in Chronic Kidney Disease and Cardiovascular Disease - The Role of Genetics and Interleukin-1 Receptor Antagonist (IL-1ra)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Chronic Kidney Disease
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There has been an exponential growth in the number of people with Chronic Kidney Disease (CKD) needing dialysis or transplantation, increasing from 209,000 in 1991 to 472,000 in 2004. This is highly c...
Eligibility Criteria
Inclusion
- 18 years of age or older;
- estimated glomerular filtration rate (eGFR) between 15-60 mL/min/1.73m2;
- Must be on stable regimens of medications that can affect inflammatory axis (Aspirin, Thiazolidinediones, statins);
- Willing and able to comply with clinic visits and study-related procedures;
- Provide signed informed consent.
Exclusion
- Recent infection or hospitalization (within one month);
- History of active or chronic hepatitis B, history of active or chronic hepatitis C, human immunodeficiency virus (HIV), history of tuberculosis (patient must be purified protein derivate negative);
- Patients taking tumor necrosis factor (TNF) inhibitors, TNF blocker, interleukin-6 (IL-6) blockers or interleukin-1 (IL-1) blocking drugs;
- Patients on steroids or receiving any other immunosuppressive agent or anti-inflammatory drug (aspirin up to 325 mg a day is allowed) one month prior;
- Have clinically significant chronic lymphopenia (low white blood cell count);
- History of malignancy in the prior 5 years. Any history of melanoma or lymphoma;
- Life expectancy less than six months;
- Intolerance to the study medication;
- The use of any other investigational drug 30 days prior to enrollment or within five half-lives of the medication used;
- Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose;
- Currently receiving parenteral iron or scheduled to receive parenteral iron during the study;
- Uncontrolled diabetes mellitus (glycated hemoglobin \> 10);
- high sensitivity c-reactive protein (hsCRP) \<2mg/L or \>30 mg/L;
- Body mass index (BMI) \> 40;
- Known diagnosis of severe congestive heart failure with documented ejection fraction (EF) \< 35%;
- Pregnant or breast-feeding women;
- Sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).
- Contraception is not required for men with documented vasectomy. \*\*Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00897715
Start Date
January 1 2013
End Date
May 8 2015
Last Update
October 1 2019
Active Locations (2)
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1
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
2
Vanderbilt University
Nashville, Tennessee, United States, 37232