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Not yet recruiting NCT06866236

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

Phase II / Phase III Interventional Chronic Kidney Diseases Acute Kidney Injury Kidney Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QRX-3.
Who it may be relevant to
Registry conditions: Chronic Kidney Diseases, Acute Kidney Injury, Kidney Failure. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Use of NAD Oxidase Modulation Agent QRX3 for Prevention and Treatment of Progressive Chronic Kidney Disease

Overview

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.

Interventions

  • Drug QRX-3
    capsule

Primary outcome measures

  • change in Glomerular filtration rate [Time frame: 1 year]
Secondary outcome measures (2)
  • change in Proteinuria [Time frame: 1 year]
  • change in rate of Glomerular filtration rate decline [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Neukidney Inc — Pasedena

Identifiers

NCT: NCT06866236 · 0001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗