Learning more about kidney function in healthy adults and people with reduced kidney function

Study to Investigate Renal Functional Reserve in Healthy Participants and in Participants With Impaired Renal Function.

This project will test whether a repeated protein-drink kidney test reliably measures kidney function in adults with normal or stable reduced kidney function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Bayer (Industry-sponsored)
• Locations: 1 site (Berlin)
• Trial ID: NCT07368712 on ClinicalTrials.gov

What this trial studies

Up to 50 adults, including healthy volunteers and people with stable kidney problems, will be enrolled for a screening visit and three study days about one month apart. On each study day participants will provide blood and urine samples before and after drinking a standardized protein shake so researchers can measure maxGFR and renal functional reserve (RFR) using markers such as creatinine and cystatin C. The RFR and maxGFR measurements are repeated across the three visits to determine how consistent and reliable the test is. No investigational drug is given and basic health data such as weight and blood pressure will also be recorded.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 who weigh 50–100 kg, are not pregnant or breastfeeding, have either normal or stable chronic kidney function, and can attend three in-person study visits about a month apart.

Not a fit: People with unstable or recently changed medical conditions (including recent surgery or new prescriptions within 60 days), known severe milk allergy, liver cirrhosis, pregnancy or breastfeeding, or weight outside 50–100 kg are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this test could give a more precise measure of kidney function and help identify reduced kidney reserve earlier or improve future kidney studies.

How similar studies have performed: Smaller prior studies using RFR and maxGFR measurements have suggested the approach can reveal subclinical kidney impairment, but reproducibility and precision have been only partially studied, so this work builds on limited existing evidence.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Known liver cirrhosis.
* Regular use of non-steroidal anti-inflammatory drugs (NSAIDs).
* Impaired kidney function with eGFR \<30 mL/min/1.73m2

Where this trial is running

Berlin

• Bayer AG - Occupational Health Services — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Bayer Clinical Trials Contact

Conditions Acute Kidney Injury, Renal Insufficiency