Chronic Kidney Disease (Stage 3-4)NCT07150338
Outcome of Use of a Novel Modulator of Oxidative Phosphorylation on Kidney Function in Patients With Progressive Chronic Kidney Disease
An observational study of Chronic Kidney Disease (Stage 3-4) and Chronic Kidney Disease (Stages 4 and 5), run by Neukidney Inc. at 1 site in United States.
Trial summary
Outcome of use of a novel Modulator of Oxidative Phosphorylation on kidney function in patients with Chronic Kidney Disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5), Proteinuria
- What is being tested?
- QRX-3 and Eseronate
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 20 Nov 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Adult patients with chronic kidney disease stages 3-5
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.
About this study
Official title: Outcome of Use of a Novel Modulator of Oxidative Phosphorylation on Kidney Function in Patients With Chronic Kidney Disease
Outcome of use of a novel Modulator of Oxidative Phosphorylation on kidney function in patients with Chronic Kidney Disease
Read the detailed description
QRX-3 ( Eseronate ) is a formulated drug designed to supply and optimize NAD+ mitochondrial availability in order 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 . This novel drug therapy stabilized the intracellular oxidative phosphorylation process a pathway mechanism that is dysregulated or abnormal in the ongoing renal tubular cell injury and damage in chronic kidney disease.
In this study the investigators evaluate the effect of intervention with this novel drug therapy on a chronic kidney disease CKD population with slowly progressively declining renal function.
- Being tested
- QRX-3, Eseronate
- Keywords
- CKD, CHRONIC KIDNEY, KIDNEY DISEASE, KIDNEY DECLINE, PROGRESSION OF CKD
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QRX-3Drug
Compounded new drug regime
EseronateDrug
Also called QRX-3
Neukidney innovative drug
| Study group | Role | What they receive |
|---|---|---|
| Patient with progressive chronic kidney disease | GFR decline Receives: Drug: QRX-3; Drug: Eseronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease rate of GFR decline
Comparism of percentage and mean change in GFR with time
Measured: 6 months
Secondary outcomes (1)
Effect on proteinuria with time
Rate of change in random urine protein/creatinine ratio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start20 May 2021
- Primary completion20 Apr 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stage 3-4)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Neukidney Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ebima Clifford Okundaye, Neukidney Inc.
- Investigators
- Ebima okundaye, MD, Principal investigator, Neukidney Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150338
- Sponsor's protocol ID
- 0001A
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Outcome of Use of a Novel Modulator of Oxidative Phosphorylation on Kidney Function in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07150338
- Acronym / sponsor ID
- 0001A
- Keywords
- CKD, CHRONIC KIDNEY, KIDNEY DISEASE, KIDNEY DECLINE, PROGRESSION OF CKD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Neukidney Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 2 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.
Outcome of use of a novel Modulator of Oxidative Phosphorylation on kidney function in patients with Chronic Kidney Disease
Detailed description
QRX-3 ( Eseronate ) is a formulated drug designed to supply and optimize NAD+ mitochondrial availability in order 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 . This novel drug therapy stabilized the intracellular oxidative phosphorylation process a pathway mechanism that is dysregulated or abnormal in the ongoing renal tubular cell injury and damage in chronic kidney disease.
In this study the investigators evaluate the effect of intervention with this novel drug therapy on a chronic kidney disease CKD population with slowly progressively declining renal function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with progressive chronic kidney disease | – | Drug: QRX-3, Drug: EseronateGFR decline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic kidney disease stages 3-5
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- • Rapid rate of decline in kidney function of > 20 % over last one year
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-3Compounded new drug regime | Drug | Patient with progressive chronic kidney disease |
| EseronateAlso: QRX-3Neukidney innovative drug | Drug | Patient with progressive chronic kidney disease |
Primary outcome
Decrease rate of GFR decline
Time frame: 6 months
Comparism of percentage and mean change in GFR with time
1 secondary outcome
Effect on proteinuria with time
Time frame: 6 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: No
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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.
Ebima okundaye, MD principal investigator
Neukidney Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (Stage 3-4) and Chronic Kidney Disease (Stages 4 and 5), run by Neukidney Inc. 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.
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?
Decrease rate of GFR decline (time frame: 6 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.