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NCT Number: NCT07368712

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

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bayer AG - Occupational Health Services

Berlin, 13353, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No investigational study intervention

Other

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.

Primary outcomes

  1. Maximun kidneyfunction determined by measurement of creatinine clearance (mGFRCR)

    Time frame: Day 1, 28 and 56

  2. Renal functional reserve by measurement of creatinine clearance (mGFRCR)

    Time frame: Day 1, 28 and 56

Secondary outcomes

  1. Maximum kidney function and renal functional reserve derived from serum creatinine-based eGFR (eGFRSCR)

    Time frame: Day 1, 28 and 56

  2. Maximum kidney function and renal functional reserve derived from serum cystatin C-based eGFR (eGFRCYS)

    Time frame: Day 1, 28 and 56

  3. 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

  4. Maximum creatinine clearance and renal functional reserve derived from plasma PENK-based eGFR (eGFRPENK)

    Time frame: Day 1, 28 and 56

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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