Ibuprofen and Biomarkers of Acute Kidney Injury After Running in the Heat

NCT06247462 | Completed Phase 1 FDA Drug

• 1 other identifier: IBU2023
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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

  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

  Change in plasma sCD14 from pre- to immediately 1 hour post-exercise.

Study Arms (2)

Ibuprofen

EXPERIMENTAL

600 mg of Ibuprofen was ingested 12- and 1-hour prior to exercise.

Drug: Ibuprofen 600 mg

Placebo (Corn Starch)

PLACEBO COMPARATOR

600 mg of corn starch was ingested 12- and 1-hour prior to exercise.

Drug: Placebo Corn Starch

Interventions

Ibuprofen 600 mg DRUG

600 mg of ibuprofen was ingested 12- and 1-hours prior to exercise.

Ibuprofen

Placebo Corn Starch DRUG

600 mg of corn starch (placebo) was ingested 12- and 1-hours prior to exercise.

Placebo (Corn Starch)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Exercise Physiology Lab

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: February 8, 2024
• Study Start: June 1, 2023
• Primary Completion: September 5, 2023
• Study Completion: September 5, 2023
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (1)