pause_circle_filledNot Yet Recruiting

, Acute kidney injury, Renal insufficiency

Bayer Identifier:
23125
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
A methodological study to learn more about kidney function in healthy people and in people with reduced kidney function

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 75 Years
    -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.
    -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

Trial summary

Enrollment Goal
50
Trial Dates
January 2026 - December 2026
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not yet recruiting
Bayer AG - Occupational Health ServicesBerlin, 13353, Germany

Primary Outcome

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

Secondary Outcome

  • Maximum kidney function and renal functional reserve derived from serum creatinine-based eGFR (eGFRSCR)
    date_rangeTime Frame:
    Day 1, 28 and 56
  • Maximum kidney function and renal functional reserve derived from serum cystatin C-based eGFR (eGFRCYS)
    date_rangeTime 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)
    date_rangeTime Frame:
    Day 1, 28 and 56
  • Maximum creatinine clearance and renal functional reserve derived from plasma PENK-based eGFR (eGFRPENK)
    date_rangeTime Frame:
    Day 1, 28 and 56

Trial design

Study to investigate renal functional reserve in healthy participants and in participants with impaired renal function.
Trial Type
Interventional
Intervention Type
Other
Trial Purpose
Diagnostic
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1