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

Phase 2

Not yet recruiting

• Conditions: Chronic Kidney Diseases; Acute Kidney Injury; Kidney Failure
• Interventions: Drug: QRX-3

• Registration Number: NCT06866236
• Lead Sponsor: Ebima Clifford Okundaye

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.

Study Timeline

• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-04
• Study First Posted: 2025-03-10
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-31
• Last Update Posted: 2025-09-08
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	QRX-3	QRX-3 - two capsules orally twice daily
placebo	QRX-3	placebo pill - one capsule orally twice daily

Primary Outcome Measures

Name	Time	Method
change in Glomerular filtration rate	1 year	change percentage in kidney function level measured with cystatin creatinine glomerular filtration rate

Secondary Outcome Measures

Name	Time	Method
change in Proteinuria	1 year	change in random urine protein/creatinine ratio
change in rate of Glomerular filtration rate decline	1 year	comparism of slopes of decline in cystatin creatinine glomerular filtrate rate

Trial Locations

Locations (1)

Neukidney Inc; 🇺🇸 Pasedena, Texas, United States

Neukidney Inc

🇺🇸Pasedena, Texas, United States

Ebima C Okundaye

Contact

8328316135

info@permierkidneyclinic.com