A Methodological Study to Learn More About Kidney Function in Healthy People and in People With R… (NCT07368712) | Clinical Trial Compass
RecruitingNot Applicable
A Methodological Study to Learn More About Kidney Function in Healthy People and in People With Reduced Kidney Function
Germany50 participantsStarted 2026-01-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically looking at how to measure kidney function more accurately using creatinine clearance, would participating help my doctor better understand the current state of my own kidney function, or is it purely for research purposes?
2This trial is recruiting both healthy people and people with reduced kidney function — given my specific kidney situation, is this study actually designed for someone like me, and what would my involvement look like day to day?
3The study is measuring something called 'renal functional reserve,' which seems to be about how much extra capacity my kidneys have — can you explain what that means for me personally, and whether knowing this information would change how you manage my care?
4Since this is listed as a methodological study rather than a treatment trial, there's no new drug or therapy being tested — does that mean the risks are mainly around the kidney function tests themselves, and what do those tests involve?
5Would taking part in this study in any way delay or interfere with starting standard treatment for my kidney condition, and is there a standard treatment path I should be considering alongside or instead of joining this study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximun kidneyfunction determined by measurement of creatinine clearance (mGFRCR)
Timeframe: Day 1, 28 and 56
2
Renal functional reserve by measurement of creatinine clearance (mGFRCR)