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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bayer Clinical Trials Contact | Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayer AG - Occupational Health Services | Recruiting | Berlin | 13353 | Germany |
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |