Chronic Kidney Disease Stages 3-5, Diabetic Kidney Disease, Hypertensive Kidney Disease
Conditions
Keywords
CKD, estimated GFR (eGFR), proteinuria, random urine protein creatinine ratio, creatinine change
Brief summary
QRX-3, a new drug that stabilized the kidney renal tubular cell and increase the activity of NAD ( nicotinamide adenine dineuclotide )within the kidney cells; leading to decrease oxidative changes intracellularly, repair of renal tubular injury and restoration of optimized renal function above baseline , will be studied in patients with progressive chronic kidney disease over 12 months . The result of the change in renal function expressed as creatinine GFR (Glomerular filtration decline) over the treatment duration will be compared in the treatment group will be compared to control group without the medication during that same period .
Interventions
DRUGQRX-3
phase 2B CKD study
Sponsors
Ebima Clifford Okundaye
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
QRX-3 added to intervention group in addition to standard therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with Chronic kidney disease stage 3-5 * 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 \> 10 % over 3 months * 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 |
|---|---|---|
| daily change in glomerular filtration rate by creatinine in mls/min | 12 months | mean change in glomerular filtration rate by creatinine in mls/min in one year compare to baseline at screening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in proteinuria by mg/g | 12 months | change in mean proteinuria measured by random urine protein/creatinine ratio at 12 months compare to control will be compared in both groups |
Countries
United States
Outcome results
None listed