Role of QRX-3 in Chronic Kidney Disease Patients in Outpatients Clinics (QRX-3 in CKD)

August 31, 2025 updated by: Ebima Clifford Okundaye

Role of QRX-3 a Novel NAD Modulator in Ambulatory Chronic Kidney Patients

QRX-3, a new drug that stabilized the kidney renal tubular cell and increase the activity of NAD ( nicotinamide adenine dineuclotide )within the kidney cells; leading to decrease oxidative changes intracellularly, repair of renal tubular injury and restoration of optimized renal function above baseline , will be studied in patients with progressive chronic kidney disease over 12 months . The result of the change in renal function expressed as creatinine GFR (Glomerular filtration decline) over the treatment duration will be compared in the treatment group will be compared to control group without the medication during that same period .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2

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

  • United States
    • Texas
      • Pasedena, Texas, United States, 77504
        • Neukidney Inc

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:

  • Patient with Chronic kidney disease stage 3-5
  • 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 > 10 % over 3 months
  • 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
control group - continued on standard therapy for CKD
Active Comparator: Intervention group
QRX-3 drug given in addition to standard therapy for CKD
Drug: QRX-3
phase 2B CKD study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
daily change in glomerular filtration rate by creatinine in mls/min
Time Frame: 12 months
mean change in glomerular filtration rate by creatinine in mls/min in one year compare to baseline at screening
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in proteinuria by mg/g
Time Frame: 12 months
change in mean proteinuria measured by random urine protein/creatinine ratio at 12 months compare to control will be compared in both groups
12 months

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 (Actual)

March 1, 2023

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 21, 2025

First Posted (Actual)

April 29, 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

  • 0002B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

if requested , deidentifiable data can be shared

IPD Sharing Time Frame

4/21/2025 to 10/21/2025

IPD Sharing Supporting Information Type

  • CSR

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.

Yes

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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