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

NCT07368712 | Recruiting

• 1 other identifier: 23125
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury, Renal Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

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

  Day 1, 28 and 56

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

  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)

  Day 1, 28 and 56

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

  Day 1, 28 and 56

Study Arms (1)

Group 1

OTHER

Other: No investigational study intervention

Interventions

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.

Group 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer AG - Occupational Health Services

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 27, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): February 19, 2027
• Study Completion (Estimated): February 19, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)