Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Rochester
With
University of Virginia
Nutramax Laboratories, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The investigators will test the safety and efficacy of Avmacol ES in Chronic Kidney Disease (CKD) patients. After having established a safe dose of 4 tablets once daily in participants with CKD Stages 3 - 4 in the pharmacokinetic (PK) phase, the investigators will enroll 100 participants from the Kidney Clinic at the University of Rochester Medical Center and Highland Hospital with CKD stages 3 - 4 who will be randomized to Avmacol ES or placebo in a 1:1 ratio in a blinded manner.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 18 years and ≤ 80 years
Estimated glomerular filtration rate (eGFR) ≥ 20 and \< 60 mL/min/1.73m2 and a decline in eGFR of ≥ 3 ml/min/1.73m2 /year in the previous 12 ± 2 months
Able to provide consent
Able to swallow Avmacol ES or placebo capsules
You may not be if
Significant co-morbid conditions with life expectancy of \< 1 year
Serum potassium of \> 5.5 milliequivalents per liter (mEq/L) at screening
New York Heart Association Class 3 or 4 heart failure symptoms, known Ejection Fraction (EF) ≤ 30% or hospital admission for heart failure within the past 3 months
Factors judged to limit adherence to interventions based on appointment attendance and medication treatment compliance; PI will make this determination
Current participation in another medical intervention study
Known to be pregnant or planning to become pregnant or currently breastfeeding; determined by self-report and medical record history. A urine pregnancy test will be completed for individuals of childbearing potential before administering the study drug, and repeated thereafter at every study visit (\~ every 3-4 months)
History of dementia documented in the medical record
On anticoagulants or immunosuppression
Under treatment for cancer
Delayed gastric emptying or similar GI conditions Non-English-speaking individuals are excluded in this randomized phase of the study because the lack of English proficiency will affect a subject's ability to report problems or adverse events. If a patient cannot read, the consent form will be read to them by the research coordinator.
