Chronic Kidney DiseasesPhase 2/3NAD agentNCT06866236
Use of New Drug QRX-3 for Prevention and Treatment of Chronic Kidney Disease Progression
A Phase 2/3 study testing QRX-3 in people with Chronic Kidney Diseases and Acute Kidney Injury, run by Ebima Clifford Okundaye at 1 site in United States.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Diseases, Acute Kidney Injury, Kidney Failure
- What is being tested?
- QRX-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Jul 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Neukidney Inc
Pasedena, Texas, 77504
Ebima C Okundaye, 8328316135, info@permierkidneyclinic.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury, Kidney Failure
- Being tested
- QRX-3
- Keywords
- CKD, CKD treatment , renal function
- Medical subject headings
- Renal Insufficiency, Chronic, Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QRX-3Drug
capsule
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | QRX-3 - two capsules orally twice daily Receives: Drug: QRX-3 |
| placebo | Placebo comparator | placebo pill - one capsule orally twice daily Receives: Drug: QRX-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Glomerular filtration rate
change percentage in kidney function level measured with cystatin creatinine glomerular filtration rate
Measured: 1 year
Secondary outcomes (2)
change in Proteinuria
change in random urine protein/creatinine ratio
Measured: 1 year
change in rate of Glomerular filtration rate decline
comparism of slopes of decline in cystatin creatinine glomerular filtrate rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo double control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,000 participants (estimated)
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
- NCT06866236
- Sponsor's protocol ID
- 0001
- Acronym
- NAD agent
- Status last verified
- Aug 2025
- First submitted
- 4 Mar 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified information of each participants trial characteristics will be available for sharing
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
- Use of NAD Oxidase Modulation Agent QRX3 for Prevention and Treatment of Progressive Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06866236
- Acronym / sponsor ID
- NAD agent / 0001
- Conditions
- Chronic Kidney Diseases, Acute Kidney Injury, Kidney Failure
- Keywords
- CKD, CKD treatment , renal function
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Ebima Clifford OkundayeIndustry (pharma, biotech, devices)
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized placebo double control
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Drug: QRX-3QRX-3 - two capsules orally twice daily |
| placebo | Placebo comparator | Drug: QRX-3placebo pill - one capsule orally twice daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (5 listed)
- 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
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-3capsule | Drug | intervention, placebo |
Primary outcome
change in Glomerular filtration rate
Time frame: 1 year
change percentage in kidney function level measured with cystatin creatinine glomerular filtration rate
2 secondary outcomes
change in Proteinuria
Time frame: 1 year
change in rate of Glomerular filtration rate decline
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Yes. de-identified information of each participants trial characteristics will be available for sharing
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing QRX-3 in people with Chronic Kidney Diseases and Acute Kidney Injury, 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: opening soon, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Glomerular filtration rate (time frame: 1 year). 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.