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

August 31, 2025 updated by: Ebima Clifford Okundaye

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

3000

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intervention
QRX-3 - two capsules orally twice daily
Drug: QRX-3
capsule
Placebo Comparator: placebo
placebo pill - one capsule orally twice daily
Drug: QRX-3
capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Glomerular filtration rate
Time Frame: 1 year
change percentage in kidney function level measured with cystatin creatinine glomerular filtration rate
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Proteinuria
Time Frame: 1 year
change in random urine protein/creatinine ratio
1 year
change in rate of Glomerular filtration rate decline
Time Frame: 1 year
comparism of slopes of decline in cystatin creatinine glomerular filtrate rate
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ebima Clifford Okundaye

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 31, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Researcher)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

de-identified information of each participants trial characteristics will be available for sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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