Chronic Kidney Disease Stages 3-5Phase 2QRX-3 in CKDNCT06948292
Role of QRX-3 in Chronic Kidney Disease Patients in Outpatients Clinics
A Phase 2 study testing QRX-3 in people with Chronic Kidney Disease Stages 3-5 and Diabetic Kidney Disease, run by Ebima Clifford Okundaye at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stages 3-5, Diabetic Kidney Disease, Hypertensive Kidney Disease
- What is being tested?
- QRX-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 30 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
- Being tested
- QRX-3
- Keywords
- CKD, estimated GFR (eGFR), proteinuria, random urine protein creatinine ratio, creatinine change
- Medical subject headings
- Diabetic Nephropathies, Hypertensive Nephropathy, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QRX-3Drug
phase 2B CKD study
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | control group - continued on standard therapy for CKD |
| Intervention group | Active comparator | QRX-3 drug given in addition to standard therapy for CKD Receives: Drug: QRX-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily change in glomerular filtration rate by creatinine in mls/min
mean change in glomerular filtration rate by creatinine in mls/min in one year compare to baseline at screening
Measured: 12 months
Secondary outcomes (1)
change in proteinuria by mg/g
change in mean proteinuria measured by random urine protein/creatinine ratio at 12 months compare to control will be compared in both groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Mar 2023
- Primary completion30 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stages 3-5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- QRX-3 added to intervention group in addition to standard therapy
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ebima Clifford Okundaye
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Ebima Clifford Okundaye, Neukidney Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948292
- Sponsor's protocol ID
- 0002B
- Acronym
- QRX-3 in CKD
- Status last verified
- Aug 2025
- First submitted
- 21 Apr 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: if requested , deidentifiable data can be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of QRX-3 a Novel NAD Modulator in Ambulatory Chronic Kidney Patients
- ClinicalTrials.gov ID
- NCT06948292
- Acronym / sponsor ID
- QRX-3 in CKD / 0002B
- Keywords
- CKD, estimated GFR (eGFR), proteinuria, random urine protein creatinine ratio, creatinine change
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Ebima Clifford OkundayeIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- QRX-3 added to intervention group in addition to standard therapy
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –control group - continued on standard therapy for CKD |
| Intervention group | Active comparator | Drug: QRX-3QRX-3 drug given in addition to standard therapy for CKD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QRX-3phase 2B CKD study | Drug | Intervention group |
Primary outcome
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
1 secondary outcome
change in proteinuria by mg/g
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. if requested , deidentifiable data can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QRX-3 in people with Chronic Kidney Disease Stages 3-5 and Diabetic Kidney Disease, run by Ebima Clifford Okundaye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily change in glomerular filtration rate by creatinine in mls/min (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.