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

Ebima Clifford Okundaye

Status and phase: Completed; Phase 2

Conditions: Hypertensive Kidney Disease; Chronic Kidney Disease Stages 3-5; Diabetic Kidney Disease

Treatments: Drug: QRX-3

Study type: Interventional

Funder types: Industry

Identifiers

NCT06948292

0002B

Details and patient eligibility

About

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 .

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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127 participants in 2 patient groups

control group

No Intervention group

Description:

control group - continued on standard therapy for CKD

Intervention group

Active Comparator group

Description:

QRX-3 drug given in addition to standard therapy for CKD

Treatment:

Drug: QRX-3