Acute Kidney Injury, Chronic Kidney Diseases, Kidney Failure
Conditions
Keywords
CKD, CKD treatment , renal function
Brief summary
Chronic kidney disease CKD is estimated to affect nearly over 800 million people globally today (with roughly 125,000 people ending up annually on dialysis in the United States alone. CKD is a contributor to illness and is associated with a diminished quality of life and reduced life expectancy . In this study the investigators are using a novel drug to target improved function of the kidneys.
Detailed description
Chronic kidney disease has been linked to impaired activity of mitochondrial dysfunction along with oxidative intracellular mechanisms that result in the cascade of progressive damage within renal tubular cells. Several treatment options for mitochondrial dysfunction have been suggested to target the loss of nephrons via renal fibrosis and tubular senescence of the kidney cells by enhancing the mitochondrial activity of these cells via the NAD/NAD+ redox pathway as well as reduce the presence of fibrogenic intracellular inflammatory markers . QRX-3 is a formulated novel drug designed to supply and optimize NAD+ mitochondrial availability and prevent this nephron loss . In this study the investigators will evaluate the effect of intervention with this novel drug therapy on chronic kidney disease CKD population with slowly declining renal function.
Interventions
DRUGQRX-3
capsule
Sponsors
Ebima Clifford Okundaye
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
placebo arm with intervention pill arm
Intervention model description
Randomized placebo double control
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria * Patient with Chronic kidney disease * Estimated Glomerular function by MDRD of less than 60mls/min * Patients with declining renal function ( as measured by eGFR by MDRD ) * Rate of decline of eGFR over the last one year of less than 20% * Negative Serology markers for CKD etiology * Provider perceived adherence to study follow up
Exclusion criteria
Rapid rate of decline in kidney function of \> 20 % over last one year * Symptomatic renal failure * Presence of any suspected Acute renal failure superimposed * Presence of cast , hematuria, or abnormal urinalysis outside of simple UTI * No known reversible cause of renal decline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Glomerular filtration rate | 1 year | change percentage in kidney function level measured with cystatin creatinine glomerular filtration rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Proteinuria | 1 year | change in random urine protein/creatinine ratio |
| change in rate of Glomerular filtration rate decline | 1 year | comparism of slopes of decline in cystatin creatinine glomerular filtrate rate |
Countries
United States
Outcome results
None listed