Acute Renal Failure (ARF)Phase 2/3QRX3 in ARFNCT07161843
Use of QRX3 for Acute Tubular Necrosis Type of Renal Failure in Hospitalized Patients ( QRX-3 in ARF)
A Phase 2/3 study testing QRX-3 in people with Acute Renal Failure (ARF) and Acute Tubular Necrosis, run by Ebima Clifford Okundaye at 1 site in United States.
Trial summary
Use of QRX-3 in hospitalized patients with pediatric and adult patients with acute tubular necrosis renal failure Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Acute Renal Failure (ARF), Acute Tubular Necrosis
- 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
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 1 Feb 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitalized patients
- presence of Acute renal failure
- Nephrologist diagnosis of Acute tubular necrosis or fractional excretion of sodium of >2%
- willingness to participate
Who cannot join
- High risk of bleeding Absence of hydronephrosis or obstructive uropathy Absence of baseline dialysis use single kidney status
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Determine the Efficacy of Investigational Drug QRX-3 in Hospitalized Patients With Acute Tubular Necrosis Pattern of Acute Renal Failure
Use of QRX-3 in hospitalized patients with pediatric and adult patients with acute tubular necrosis renal failure
- Conditions
- Acute Renal Failure (ARF), Acute Tubular Necrosis
- Being tested
- QRX-3
- Keywords
- acute renal failure, acute tubular necrosis
- Medical subject headings
- Acute Kidney Injury, Kidney Cortex Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QRX-3Drug
Also called Eseronate
Combination of QRX-3 with standard therapy will be given to one arm in trial , another arm will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Use of QRX-3 in addition to standard therapy | Experimental | QRX-3 drug orally as twice daily in addition to standard conventional therapy will be given to this group for 28 days Receives: Drug: QRX-3 |
| control group | Placebo comparator | placebo twice daily will be given to this group in addition to standard therapy Receives: Drug: QRX-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in creatinine glomerular filtration rate
compare the outcome effect of added QRX-3 drug to placebo in addition to standard therapy on the rate of change from baseline of creatinine GFR in ATN patients
Measured: 28 days
Secondary outcomes (2)
daily change in glomerular filtration rate in ml/min
daily change in GFR by creatinine in mls/min
Measured: 7 days
daily change in cystatin C level in mg/dl
daily change in measured cystatin C level
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start30 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Renal Failure (ARF)Studies 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
- added QRX-3 to standard regime
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 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
- NCT07161843
- Sponsor's protocol ID
- 0002
- Acronym
- QRX3 in ARF
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Efficacy of Investigational Drug QRX-3 in Hospitalized Patients With Acute Tubular Necrosis Pattern of Acute Renal Failure
- ClinicalTrials.gov ID
- NCT07161843
- Acronym / sponsor ID
- QRX3 in ARF / 0002
- Conditions
- Acute Renal Failure (ARF), Acute Tubular Necrosis
- Keywords
- acute renal failure, acute tubular necrosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ebima Clifford OkundayeIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Sep 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.
Use of QRX-3 in hospitalized patients with pediatric and adult patients with acute tubular necrosis renal failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- added QRX-3 to standard regime
| Arm | Type | Receives |
|---|---|---|
| Use of QRX-3 in addition to standard therapy | Experimental | Drug: QRX-3QRX-3 drug orally as twice daily in addition to standard conventional therapy will be given to this group for 28 days |
| control group | Placebo comparator | Drug: QRX-3placebo twice daily will be given to this group in addition to standard therapy |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized patients
- presence of Acute renal failure
- Nephrologist diagnosis of Acute tubular necrosis or fractional excretion of sodium of >2%
- willingness to participate
Key exclusion criteria (1 listed)
- High risk of bleeding Absence of hydronephrosis or obstructive uropathy Absence of baseline dialysis use single kidney status
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-3Also: EseronateCombination of QRX-3 with standard therapy will be given to one arm in trial , another arm will receive placebo | Drug | Use of QRX-3 in addition to standard therapy, control group |
Primary outcome
Rate of change in creatinine glomerular filtration rate
Time frame: 28 days
compare the outcome effect of added QRX-3 drug to placebo in addition to standard therapy on the rate of change from baseline of creatinine GFR in ATN patients
2 secondary outcomes
daily change in glomerular filtration rate in ml/min
Time frame: 7 days
daily change in cystatin C level in mg/dl
Time frame: 7 days
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 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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 Acute Renal Failure (ARF) and Acute Tubular Necrosis, 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 4 inclusion and 1 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 18 Feb 2026. 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?
Contact Ebima Okundaye, MD (9738855457, cliffordebima@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in creatinine glomerular filtration rate (time frame: 28 days). 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 18 Feb 2026.