Status:
COMPLETED
Nutrition, Inflammation and Insulin Resistance in End Stage Renal Disease-Aim 2
Lead Sponsor:
VA Office of Research and Development
Conditions:
ESRD
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
By 2030 an estimated 2 million people in the US will need dialysis or transplantation for advanced kidney failure. An even more disturbing statistic is that mortality in End Stage Renal Disease (ESRD)...
Eligibility Criteria
Inclusion
- Patients on CHD undergoing three time a week therapy for more than 6 months;
- Age 21 years old;
- Acceptable dialysis adequacy (spKt/V \> 1.2);
- A patent, well-functioning, arterio-venous dialysis access;
- Ability to give informed consent;
- Life expectancy greater than 6 months;
- BMI \>=20 and \<=45.
Exclusion
- Pregnancy;
- Intolerance or allergy to the study medication (including the metabolic clamp studies);
- Severe, unstable, active inflammatory disease (active infection, active connective tissue disorder), active cancer or cancer history in the prior 5 years except skin cancer, AIDS-HIV, active or history of liver disease (including hepatitis B virus and hepatitis C virus);
- Hospitalization or infection within 1 month prior to the study;
- Patients receiving steroids and/or other immunosuppressive agents (Prednisone \> 5 mg/day; excluding inhaled and topical steroids);
- Diabetes Mellitus on insulin therapy;
- Previous history of tuberculosis (TB) with or without documented adequate therapy;
- Patients with recent close exposure to an individual with active TB;
- Females using oral contraceptives;
- Patients with New York Heart Association (NYHA) Class III or IV heart failure;
- Patients with a history of angina, myocardial infarction, transient ischemic attacks, or strokes within the last 6 months.
Key Trial Info
Start Date :
October 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02278562
Start Date
October 22 2014
End Date
March 1 2017
Last Update
February 6 2025
Active Locations (1)
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1
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637