Use of New Drug QRX-3 for Prevention and Treatment of Chronic Kidney Disease Progression

NCT ID: NCT06866236

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-07-31

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.

Conditions

Chronic Kidney Diseases; Acute Kidney Injury; Kidney Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention

QRX-3 - two capsules orally twice daily

Group Type: ACTIVE_COMPARATOR

QRX-3

Intervention Type: DRUG

capsule

placebo

placebo pill - one capsule orally twice daily

Group Type: PLACEBO_COMPARATOR

QRX-3

Intervention Type: DRUG

capsule

Interventions

QRX-3

capsule

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ebima Clifford Okundaye

INDUSTRY

Sponsor Role: lead

Responsible Party

Ebima Clifford Okundaye

President

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Neukidney Inc

Pasedena, Texas, United States

Countries

United States

Facility Contacts

Ebima C Okundaye

Role: primary

info@permierkidneyclinic.com

8328316135

Other Identifiers

0001

Identifier Type: -

Identifier Source: org_study_id