Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572215
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
DYNAMic Renal Assessment NOvel Methods to Assess KIDNEY Functional Reserve
Sponsor:
None
Organization:
None
Study Overview
Official Title:
DYNAMic Renal Assessment NOvel Methods to Assess KIDNEY Functional Reserve
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DYNAMO
Brief Summary:
This is a feasibility study to assess new more practical ways of measuring renal reserve
Detailed Description:
Quantification of glomerular filtration rate GFR over time is the standard assessment of kidney function In clinical practice the endogenous marker serum creatinine concentration is used as a static assessment of kidney function to estimate GFR However serum creatinine fails to increase until at least 50 of kidney tissue is lost2 thus is an inadequate indicator of early CKD
GFR like many other physiological processes is not static and augments temporarily to stimuli such as exercise and protein intake by up to 25 from baseline in healthy individuals3 Similar to cardiac function stress tests which predict adverse outcomes inability to respond to renal stressors or reduced renal reserve has been demonstrated to occur prior to development of CKD eg in patients with diabetes and previous acute kidney injury AKI and is associated with vulnerability to future AKI despite the presence of apparently normal kidney function measured by serum creatinine concentration4 Renal reserve is lost with progressive CKD4 and has also been demonstrated to relate to severity of histological lesions5
Current measurements of renal reserve stimulated increase in GFR due to augmented renal blood flow above basal fasting values involve administration of a compound that is freely filtered by the glomerulus unaffected by tubular function and is physiologically inert with assessment before and after an oral protein load or amino acid infusion which induces arterial vasodilation increasing renal blood flow and GFR
The study proposes a comparison of two novel methods of dynamic renal function testing with renal reserve testing
GFR like many other physiological processes is not static and augments temporarily to stimuli such as exercise and protein intake by up to 25 from baseline in healthy individuals3 Similar to cardiac function stress tests which predict adverse outcomes inability to respond to renal stressors or reduced renal reserve has been demonstrated to occur prior to development of CKD eg in patients with diabetes and previous acute kidney injury AKI and is associated with vulnerability to future AKI despite the presence of apparently normal kidney function measured by serum creatinine concentration4 Renal reserve is lost with progressive CKD4 and has also been demonstrated to relate to severity of histological lesions5
Current measurements of renal reserve stimulated increase in GFR due to augmented renal blood flow above basal fasting values involve administration of a compound that is freely filtered by the glomerulus unaffected by tubular function and is physiologically inert with assessment before and after an oral protein load or amino acid infusion which induces arterial vasodilation increasing renal blood flow and GFR
The study proposes a comparison of two novel methods of dynamic renal function testing with renal reserve testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None