Use of New Drug QRX-3 for Prevention and Treatment of Chronic Kidney Disease Progression (NAD agent)

Ebima Clifford Okundaye

Status and phase: Begins enrollment in 6 months; Phase 3; Phase 2

Conditions: Kidney Failure; Chronic Kidney Diseases; Acute Kidney Injury

Treatments: Drug: QRX-3

Study type: Interventional

Funder types: Industry

Identifiers

NCT06866236

0001

Details and patient eligibility

About

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 we are using a novel drug to target improved function of the kidneys.

Full 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 we evaluate the effect of intervention with this novel drug therapy on chronic kidney disease CKD population with slowly declining renal function.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,400 participants in 2 patient groups, including a placebo group

intervention

Active Comparator group

Description:

QRX-3 - two capsules twice daily

Treatment:

Drug: QRX-3

placebo

Placebo Comparator group

Description:

placebo pill - one pill twice daily

Treatment:

Drug: QRX-3