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

0000

Details and patient eligibility

About

QRX-3, a new drug that stabilized the kidney renal tubular cell and increase the activity of NAD within the kidney cells, is expected to improve baseline renal function when given over a period of one year . The result of the change in renal function will be compared to control 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 in addition to standard therapy for CKD

Treatment:

Drug: QRX-3