Acute Kidney Injury, Renal Insufficiency
Conditions
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.
Interventions
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.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Contacts
CONTACTBayer Clinical Trials Contact
Outcome results
None listed