Role of QRX-3 in Chronic Kidney Disease Patients in Outpatients Clinics

Ebima Clifford Okundaye127 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

127

Conditions

Chronic Kidney Disease Stages 3-5 Diabetic Kidney Disease Hypertensive Kidney Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

daily change in glomerular filtration rate by creatinine in mls/min

mean change in glomerular filtration rate by creatinine in mls/min in one year compare to baseline at screening

Time frame: 12 months

Secondary Outcomes

change in proteinuria by mg/g

change in mean proteinuria measured by random urine protein/creatinine ratio at 12 months compare to control will be compared in both groups