Acute Kidney InjuryPhase 1NCT06247462
Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat
A Phase 1 study testing Ibuprofen 600 mg in people with Acute Kidney Injury, run by University of New Mexico at 1 site in United States.
Trial summary
The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at moderate intensity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Ibuprofen 600 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 5 Sep 2023
- Phase
- Phase 1
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Physically active (engage in at least 150 minutes of moderate to vigorous intensity exercise per week)
- between the ages of 18 and 45
- Able to run continuously for at least 60 minutes
- Able to speak and read English.
Who cannot join
- Non-English speakers, prisoners, pregnant women, or persons requiring a LAR
- Previous history of heat stroke or heat illness
- Currently experiencing a sunburn or other burn injury
- Have repeated exposure to heat, such as hot baths, sauna, or travel to a hot environment
- Has resided in a hot climate within 2 months prior to the trial
- Answered "yes" to at least one question on the physical activity readiness questionnaire
Show all 13Show fewer
- Shows signs or symptoms of or are known to have cardiovascular, renal, metabolic, or pulmonary disease as determined by a health questionnaire
- Are a current smoker
- History of regular gastrointestinal distress
- Known history of stomach ulcers or taking blood thinning medication
- Known allergy to ibuprofen
- Have a resting blood pressure greater than 140 systolic or 90 diastolic
- Do not engage in at least 150 minutes of moderate to vigorous intensity exercise per week.
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise Physiology Lab
Albuquerque, New Mexico, 87131
About this study
The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at moderate intensity. Urine, plasma, and serum samples were collected pre-, post-, and 1hour post-exercise to assess biomarkers of acute kidney injury. This was a double blind, randomized crossover design, so that participants completed the alternate trial (ibuprofen or placebo) at least seven days later.
- Conditions
- Acute Kidney Injury
- Being tested
- Ibuprofen 600 mg, Placebo Corn Starch
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 600 mgDrug
600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise.
Placebo Corn StarchDrug
600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | 600 mg of Ibuprofen was ingested 12- and 1-hour prior to exercise. Receives: Drug: Ibuprofen 600 mg |
| Placebo (Corn Starch) | Placebo comparator | 600 mg of corn starch was ingested 12- and 1-hour prior to exercise. Receives: Drug: Placebo Corn Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (IGFBP7xTIMP2)
The product of urinary IGFBP7 and urinary TIMP2 (IGFBP7xTIMP2) will be measured at all time points.
Measured: Change in urinary IGFBP7xTIMP2 pre-exercise and 1 hour post-exercise.
Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (Urinary NGAL)
Urinary NGAL will be measured at all time points.
Measured: Change in urinary NGAL pre-exercise and peak post-exercise.
Biomarker of glomerular filtration rate from Ibuprofen Ingestion Prior to Exercise in the Heat (Serum cystatin C)
Serum cystatin C will be measured at all time points.
Measured: Change in serum cystatin C pre-exercise and 1 hour post-exercise.
Secondary outcomes (3)
Circulating Marker of Intestinal Injury from Ibuprofen Ingestion Prior to Exercise in the Heat
Plasma I-FABP is a circulating marker of intestinal damage.
Measured: Change in plasma I-FABP from pre- to immediately 1 hour post-exercise.
Circulating Marker of Intestinal Permeability from Ibuprofen Ingestion Prior to Exercise in the Heat
Plasma LBP is a circulating marker of intestinal permeability.
Measured: Change in plasma LBP from pre- to immediately 1 hour post-exercise.
Circulating Marker of Endotoxemia from Ibuprofen Ingestion Prior to Exercise in the Heat
Plasma sCD14 is a circulating marker of endotoxemia.
Measured: Change in plasma sCD14 from pre- to immediately 1 hour post-exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Jun 2023
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247462
- Sponsor's protocol ID
- IBU2023
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2023
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat
- ClinicalTrials.gov ID
- NCT06247462
- Acronym / sponsor ID
- IBU2023
- Conditions
- Acute Kidney Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 8 Feb 2024 (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.
The goal of this study is to determine if ibuprofen prior to exercise in the heat worsens biomarkers of acute kidney injury. Participants were given 600mg of ibuprofen or placebo (corn starch) 12- and 1-hour prior to running for 1-hour in a hot environment (35°C) at moderate intensity. Urine, plasma, and serum samples were collected pre-, post-, and 1hour post-exercise to assess biomarkers of acute kidney injury. This was a double blind, randomized crossover design, so that participants completed the alternate trial (ibuprofen or placebo) at least seven days later.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Ibuprofen 600 mg600 mg of Ibuprofen was ingested 12- and 1-hour prior to exercise. |
| Placebo (Corn Starch) | Placebo comparator | Drug: Placebo Corn Starch600 mg of corn starch was ingested 12- and 1-hour prior to exercise. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Physically active (engage in at least 150 minutes of moderate to vigorous intensity exercise per week)
- between the ages of 18 and 45
- Able to run continuously for at least 60 minutes
- Able to speak and read English.
Key exclusion criteria (13 listed)
- Non-English speakers, prisoners, pregnant women, or persons requiring a LAR
- Previous history of heat stroke or heat illness
- Currently experiencing a sunburn or other burn injury
- Have repeated exposure to heat, such as hot baths, sauna, or travel to a hot environment
- Has resided in a hot climate within 2 months prior to the trial
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 |
|---|---|---|
| Ibuprofen 600 mg600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise. | Drug | Ibuprofen |
| Placebo Corn Starch600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise. | Drug | Placebo (Corn Starch) |
Primary outcome
Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (IGFBP7xTIMP2)
Time frame: Change in urinary IGFBP7xTIMP2 pre-exercise and 1 hour post-exercise.
The product of urinary IGFBP7 and urinary TIMP2 (IGFBP7xTIMP2) will be measured at all time points.
Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (Urinary NGAL)
Time frame: Change in urinary NGAL pre-exercise and peak post-exercise.
Urinary NGAL will be measured at all time points.
Biomarker of glomerular filtration rate from Ibuprofen Ingestion Prior to Exercise in the Heat (Serum cystatin C)
Time frame: Change in serum cystatin C pre-exercise and 1 hour post-exercise.
Serum cystatin C will be measured at all time points.
3 secondary outcomes
Circulating Marker of Intestinal Injury from Ibuprofen Ingestion Prior to Exercise in the Heat
Time frame: Change in plasma I-FABP from pre- to immediately 1 hour post-exercise.
Circulating Marker of Intestinal Permeability from Ibuprofen Ingestion Prior to Exercise in the Heat
Time frame: Change in plasma LBP from pre- to immediately 1 hour post-exercise.
Circulating Marker of Endotoxemia from Ibuprofen Ingestion Prior to Exercise in the Heat
Time frame: Change in plasma sCD14 from pre- to immediately 1 hour post-exercise.
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 26 Jan 2026.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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 1 study testing Ibuprofen 600 mg in people with Acute Kidney Injury, run by University of New Mexico 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 13 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 26 Jan 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Biomarker of Acute Kidney Injury Risk from Ibuprofen Ingestion Prior to Exercise in the Heat (IGFBP7xTIMP2) (time frame: Change in urinary IGFBP7xTIMP2 pre-exercise and 1 hour post-exercise.). The study lists 3 primary outcomes in all. 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 26 Jan 2026.