Acute Kidney InjuryNCT04929418
Differential Adaptation of Renal Function in Intense Physical Exercise
A study testing 10 km continuous running and 1.5 km continuous swimming in people with Acute Kidney Injury, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
Trial summary
In recent years there has been a significant increase in the number of participants in high intensity and duration sports events. This type of physical exercise has been reported to lead to an apparently transitory deterioration in kidney function. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- 10 km continuous running and 1.5 km continuous swimming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 20 Mar 2020
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Able to understand the objectives of the study and to provide informed consent.
- Body mass index between 18.5 and 29.9 kg / m2
- Active sportsman/woman (defined as previous experience with the planned tests and performing vigorous-intensity aerobic activity at least three times per week).
Who cannot join
- History of chronic kidney disease, hypertension, uncontrolled diabetes (defined as fasting glucose levels ≥200 mg/dl or HbA1c ≥9%), peripheral vascular disease, heart disease, neurological disease or thyroid disease.
- Use of NSAIDs in the 72h prior to the test.
- Consumption of statins or anabolic steroids.
- Some kind of major physical injury in the four months prior to the tests.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Adaptation of Renal Function in Two Types of Intense Physical Exercise
In recent years there has been a significant increase in the number of participants in high intensity and duration sports events. This type of physical exercise has been reported to lead to an apparently transitory deterioration in kidney function. The injury mechanisms involved in this process have not been fully studied, but several have been proposed as potential causes, such as tissue ischemia, disruption of the permeability of the glomerular basement membrane, damage to the ultra-structure of skeletal muscle, structural involvement of the renal parenchyma, exercise-associated hyperthermia or insufficient hydration during exercise.
Urinary biomarkers, which are a more precise tool than serum creatinine when it comes to detecting subclinical kidney damage, may be key to elucidate the characteristics of exercise-related kidney injury.
The aim of this study is to carry out an integrative analysis of the development of exercise-associated subclinical acute kidney injury.
- Conditions
- Acute Kidney Injury
- Being tested
- 10 km continuous running, 1.5 km continuous swimming
- Keywords
- Acute kidney injury
- 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.
10 km continuous runningOther
Trial participants will perform a 10 km continuous running exercise
1.5 km continuous swimmingOther
Trial participants will perform a 1.5 km continuous swimming exercise.
| Study group | Role | What they receive |
|---|---|---|
| 10 km continuous running | Other | Participants will perform a test of 10 km coninuous running. Receives: Other: 10 km continuous running; Other: 1.5 km continuous swimming |
| 1.5 km swimming | Other | Participants will perform a test of 1.5 km coninuous swimming. Receives: Other: 10 km continuous running; Other: 1.5 km continuous swimming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels
Measured: 24 hours
Absolute change in urinary Kidney Injury Molecule-1 (KIM-1) levels
Measured: 24 hours
Secondary outcomes (2)
Absolute change in serum creatinine levels
Measured: 24 hours
Absolute change in proteinuria
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion20 Mar 2020
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Trial participants will participate sequentially in two tests that involve high intensity physical exercise (10 km continuous running and 1.5 km continuous swimming). Both tests will be separated from each other a minimum of 30 days.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Gerencia Regional de Salud de Castilla y Leon, Instituto de Investigación Biomédica de Salamanca, Centro Regional de Medicina Deportiva de Castilla y León
- Responsible party
- Principal investigator, Armando Coca Rojo, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929418
- Sponsor's protocol ID
- PI-GR-18-914
- Other IDs
- GRS 1732A/18
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Adaptation of Renal Function in Two Types of Intense Physical Exercise
- ClinicalTrials.gov ID
- NCT04929418
- Acronym / sponsor ID
- PI-GR-18-914
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Clínico Universitario de ValladolidUniversity, hospital or other
- Collaborators
- Gerencia Regional de Salud de Castilla y Leon, Instituto de Investigación Biomédica de Salamanca, Centro Regional de Medicina Deportiva de Castilla y León
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 18 Jun 2021 (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.
In recent years there has been a significant increase in the number of participants in high intensity and duration sports events. This type of physical exercise has been reported to lead to an apparently transitory deterioration in kidney function. The injury mechanisms involved in this process have not been fully studied, but several have been proposed as potential causes, such as tissue ischemia, disruption of the permeability of the glomerular basement membrane, damage to the ultra-structure of skeletal muscle, structural involvement of the renal parenchyma, exercise-associated hyperthermia or insufficient hydration during exercise.
Urinary biomarkers, which are a more precise tool than serum creatinine when it comes to detecting subclinical kidney damage, may be key to elucidate the characteristics of exercise-related kidney injury.
The aim of this study is to carry out an integrative analysis of the development of exercise-associated subclinical acute kidney injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Trial participants will participate sequentially in two tests that involve high intensity physical exercise (10 km continuous running and 1.5 km continuous swimming). Both tests will be separated from each other a minimum of 30 days.
| Arm | Type | Receives |
|---|---|---|
| 10 km continuous running | Other | Other: 10 km continuous running, Other: 1.5 km continuous swimmingParticipants will perform a test of 10 km coninuous running. |
| 1.5 km swimming | Other | Other: 10 km continuous running, Other: 1.5 km continuous swimmingParticipants will perform a test of 1.5 km coninuous swimming. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Able to understand the objectives of the study and to provide informed consent.
- Body mass index between 18.5 and 29.9 kg / m2
- Active sportsman/woman (defined as previous experience with the planned tests and performing vigorous-intensity aerobic activity at least three times per week).
Key exclusion criteria (4 listed)
- History of chronic kidney disease, hypertension, uncontrolled diabetes (defined as fasting glucose levels ≥200 mg/dl or HbA1c ≥9%), peripheral vascular disease, heart disease, neurological disease or thyroid disease.
- Use of NSAIDs in the 72h prior to the test.
- Consumption of statins or anabolic steroids.
- Some kind of major physical injury in the four months prior to the tests.
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 |
|---|---|---|
| 10 km continuous runningTrial participants will perform a 10 km continuous running exercise | Other | 1.5 km swimming, 10 km continuous running |
| 1.5 km continuous swimmingTrial participants will perform a 1.5 km continuous swimming exercise. | Other | 1.5 km swimming, 10 km continuous running |
Primary outcome
Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels
Time frame: 24 hours
Absolute change in urinary Kidney Injury Molecule-1 (KIM-1) levels
Time frame: 24 hours
2 secondary outcomes
Absolute change in serum creatinine levels
Time frame: 24 hours
Absolute change in proteinuria
Time frame: 24 hours
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 30 Apr 2026.
- 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.
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 study testing 10 km continuous running and 1.5 km continuous swimming in people with Acute Kidney Injury, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
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 4 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 30 Apr 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 Spain. 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?
Absolute change in urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) levels (time frame: 24 hours). The study lists 2 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 30 Apr 2026.