A Methodological Study to Learn More About Kidney Function in Healthy People and in People With Reduced Kidney Function

NCT07368712 · tracked via the Priya Life Science Germany tracker

Sponsor

Bayer

Phase

Not applicable

Started

2026-01-06

Last updated

2026-07-06

Condition(s) studied

Acute Kidney Injury, Renal Insufficiency

Investigational drug(s) / intervention(s)

No investigational study intervention

No investigational study intervention: 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 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

Maximun kidneyfunction determined by measurement of creatinine clearance (mGFRCR) — Day 1, 28 and 56
Renal functional reserve by measurement of creatinine clearance (mGFRCR) — Day 1, 28 and 56

Trial sites (1)

Facility	City	Region	Status
Bayer AG - Occupational Health Services	Berlin	Germany	Recruiting

More Bayer trials in Germany

Study to Learn More About the Safety of Drug Jivi Over a Long Period of Time in Previously Treated Patients With Hemophilia A (Bleeding Disorder Resulting From a Lack of FVIII) Who Are Receiving Jivi Regularly at Their Treating Doctors to Prevent Bleeding Active, not recruiting

A Study to Learn About How Well BAY 3401016 Works in Adults With Alport Syndrome Active, not recruiting

A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2) Recruiting

A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria Active, not recruiting

A Study to Learn About the Use of Acoramidis in Patients With a Heart Condition Called Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in a Real-world Setting Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07368712 on ClinicalTrials.gov ↗ ← All trials in Germany