Acute Kidney Injury, Renal InsufficiencyNCT07368712
A Methodological Study to Learn More About Kidney Function in Healthy People and in People With Reduced Kidney Function
A study testing No investigational study intervention in people with Acute Kidney Injury, Renal Insufficiency, run by Bayer at 1 site in Germany.
Trial summary
The main purpose of this study is to investigate how reliable a test assessing the renal functional reserve (RFR) and the maximum glomerular filtration rate (maxGFR) are. MaxGFR and RFR assessments are repeated twice at 1-month intervals. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Kidney Injury, Renal Insufficiency
- What is being tested?
- No investigational study intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jan 2026to 19 Feb 2027
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be 18 to 75 years of age inclusive, at the time of signing the ICF.
- Stable medical condition defined as no new drug or other treatment prescribed for a chronic condition within 60 days prior to Study Day 1.
- Body weight between 50 and 100 kg.
- Female Participants: A participant is eligible to participate if not pregnant or breastfeeding. If a urine test cannot be confirmed as negative at screening (e.g., an ambiguous result), the participant must be excluded from participation.
Who cannot join
- Recent surgical intervention within 60 days prior to Study Day 1.
- New clinical diagnosis established within 60 days prior to Study Day 1.
- New drug prescription within 60 days prior to Study Day 1.
- Relevant change in severity of any medical condition within 60 days prior to Study Day 1, e.g. disease flare.
- Known congenital amino acid metabolism disorders.
- Severe hypersensitivity to milk products.
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- Known liver cirrhosis.
- Regular use of non-steroidal anti-inflammatory drugs (NSAIDs).
- Impaired kidney function with eGFR <30 mL/min/1.73m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Bayer AG - Occupational Health Services
Berlin, State of Berlin, 13353
About this study
Official title: Study to Investigate Renal Functional Reserve in Healthy Participants and in Participants With Impaired Renal Function.
The main purpose of this study is to investigate how reliable a test assessing the renal functional reserve (RFR) and the maximum glomerular filtration rate (maxGFR) are. MaxGFR and RFR assessments are repeated twice at 1-month intervals. If precise, this test may improve the measure of kidney function and be useful in future studies for people with chronic kidney problems.
To do this, the researchers will collect and analyze information about kidney function from up to 50 adults, including healthy people and people with stable kidney problems. Each person will come to the study center for a screening visit and then three study days, each about a month apart. On each study day, participants will have blood and urine samples taken before and after drinking a protein shake. The tests will measure things like creatinine, cystatin C, and other markers in the blood and urine to see how the kidneys are working. The study will also record basic health information, weight, blood pressure, and any medicines being taken.
The study will last about 2 to 2.5 months for each participant.
- Conditions
- Acute Kidney Injury, Renal Insufficiency
- Being tested
- No investigational study intervention
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No investigational study interventionOther
The study does not involve the administration of any study intervention, investigational medicinal product, or device. Participants will undergo blood collection and urine sampling both before and after consuming a high-protein meal.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Not described Receives: Other: No investigational study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximun kidneyfunction determined by measurement of creatinine clearance (mGFRCR)
Measured: Day 1, 28 and 56
Renal functional reserve by measurement of creatinine clearance (mGFRCR)
Measured: Day 1, 28 and 56
Secondary outcomes (4)
Maximum kidney function and renal functional reserve derived from serum creatinine-based eGFR (eGFRSCR)
Measured: Day 1, 28 and 56
Maximum kidney function and renal functional reserve derived from serum cystatin C-based eGFR (eGFRCYS)
Measured: Day 1, 28 and 56
Maximum kidney function and renal functional reserve derived from serum creatinine-based and serum cystatin C-based eGFR (eGFRSCR-CYS)
Measured: Day 1, 28 and 56
Maximum creatinine clearance and renal functional reserve derived from plasma PENK-based eGFR (eGFRPENK)
Measured: Day 1, 28 and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start6 Jan 2026
- Primary completion19 Feb 2027 (estimated)
- Study completion19 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 Kidney Injury, Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368712
- Sponsor's protocol ID
- 23125
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate Renal Functional Reserve in Healthy Participants and in Participants With Impaired Renal Function.
- ClinicalTrials.gov ID
- NCT07368712
- Acronym / sponsor ID
- 23125
- Conditions
- Acute Kidney Injury, Renal Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 19 Feb 2027 (estimated)
- Study completion
- 19 Feb 2027 (estimated)
- First posted
- 27 Jan 2026 (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 main purpose of this study is to investigate how reliable a test assessing the renal functional reserve (RFR) and the maximum glomerular filtration rate (maxGFR) are. MaxGFR and RFR assessments are repeated twice at 1-month intervals. If precise, this test may improve the measure of kidney function and be useful in future studies for people with chronic kidney problems.
To do this, the researchers will collect and analyze information about kidney function from up to 50 adults, including healthy people and people with stable kidney problems. Each person will come to the study center for a screening visit and then three study days, each about a month apart. On each study day, participants will have blood and urine samples taken before and after drinking a protein shake. The tests will measure things like creatinine, cystatin C, and other markers in the blood and urine to see how the kidneys are working. The study will also record basic health information, weight, blood pressure, and any medicines being taken.
The study will last about 2 to 2.5 months for each participant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: No investigational study intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must be 18 to 75 years of age inclusive, at the time of signing the ICF.
- Stable medical condition defined as no new drug or other treatment prescribed for a chronic condition within 60 days prior to Study Day 1.
- Body weight between 50 and 100 kg.
- Female Participants: A participant is eligible to participate if not pregnant or breastfeeding. If a urine test cannot be confirmed as negative at screening (e.g., an ambiguous result), the participant must be excluded from participation.
Key exclusion criteria (9 listed)
- Recent surgical intervention within 60 days prior to Study Day 1.
- New clinical diagnosis established within 60 days prior to Study Day 1.
- New drug prescription within 60 days prior to Study Day 1.
- Relevant change in severity of any medical condition within 60 days prior to Study Day 1, e.g. disease flare.
- Known congenital amino acid metabolism disorders.
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 |
|---|---|---|
| No investigational study interventionThe study does not involve the administration of any study intervention, investigational medicinal product, or device. Participants will undergo blood collection and urine sampling both before and after consuming a high-protein meal. | Other | Group 1 |
Primary outcome
Maximun kidneyfunction determined by measurement of creatinine clearance (mGFRCR)
Time frame: Day 1, 28 and 56
Renal functional reserve by measurement of creatinine clearance (mGFRCR)
Time frame: Day 1, 28 and 56
4 secondary outcomes
Maximum kidney function and renal functional reserve derived from serum creatinine-based eGFR (eGFRSCR)
Time frame: Day 1, 28 and 56
Maximum kidney function and renal functional reserve derived from serum cystatin C-based eGFR (eGFRCYS)
Time frame: Day 1, 28 and 56
Maximum kidney function and renal functional reserve derived from serum creatinine-based and serum cystatin C-based eGFR (eGFRSCR-CYS)
Time frame: Day 1, 28 and 56
Maximum creatinine clearance and renal functional reserve derived from plasma PENK-based eGFR (eGFRPENK)
Time frame: Day 1, 28 and 56
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 14 Oct 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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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 study testing No investigational study intervention in people with Acute Kidney Injury, Renal Insufficiency, run by Bayer at 1 site in Germany.
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 9 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: looking for participants now, as of the sponsor's last update on 14 Oct 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 Germany. 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?
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 Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximun kidneyfunction determined by measurement of creatinine clearance (mGFRCR) (time frame: Day 1, 28 and 56). 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 14 Oct 2026.