Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT07217158
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-27
First Post:
2025-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Role of ROS and cAMP-PKA Signaling-related Biomarkers on Renal Disease Severity and Progression in ADPKD
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to determine the prognostic value of markers of ROS and cAMP-PKA signaling to assess disease severity and progression in patients with ADPKD.
Detailed Description:
Individuals with ADPKD are born with normal renal function that is preserved for several decades. By the time the GFR starts to decline, most of the kidneys have been replaced by cysts. The median age of end-stage renal disease (ESRD) is 54 years for PKD1 and 74 years for PKD2, but the rate of disease progression varies widely among individuals. This variability, along with the maintenance of normal GFR until the late stages, represents a significant challenge for nephrologists in following these patients. It is difficult to predict disease progression or evaluate a new therapy based solely on renal function markers at an early stage. On the other hand, if new therapies are implemented when GFR starts to decline and most irreversible damage has occurred, they are less likely to be effective. Hence, identifying robust, early disease biomarkers predictive of GFR decline and disease progression is crucial.
The improvement of imaging techniques over the years has provided insights into the natural history of the disease and facilitated the observation of its structural progression. The Consortium for Radiologic Imaging Studies of PKD (CRISP) study has shown that in patients with ADPKD, the increase in kidney and cyst volumes directly correlates with GFR decline, underscoring the potential of TKV to monitor disease progression and as a primary or secondary endpoint in clinical trials for ADPKD. However, TKV has limitations as a biomarker, as it is fairly crude and does not fully capture the pathophysiological processes underlying the development and progression of the disease. Therefore, biomarkers related to the underlying molecular mechanisms may detect renal injury before permanent anatomical damage occurs.
The investigators' broad objective is to determine the value of NOX4, as well as surrogate markers for ROS, mitochondrial injury, and metabolic pathways, to assess disease severity and progression from early stages.
Participants in this study will have blood and urine samples collected to determine biomarkers of oxidative stress, antioxidant response, related metabolite levels, as well as kidney injury markers. In addition, an abdominal MRI will be performed to determine the patient's total kidney volume (TKV).
The improvement of imaging techniques over the years has provided insights into the natural history of the disease and facilitated the observation of its structural progression. The Consortium for Radiologic Imaging Studies of PKD (CRISP) study has shown that in patients with ADPKD, the increase in kidney and cyst volumes directly correlates with GFR decline, underscoring the potential of TKV to monitor disease progression and as a primary or secondary endpoint in clinical trials for ADPKD. However, TKV has limitations as a biomarker, as it is fairly crude and does not fully capture the pathophysiological processes underlying the development and progression of the disease. Therefore, biomarkers related to the underlying molecular mechanisms may detect renal injury before permanent anatomical damage occurs.
The investigators' broad objective is to determine the value of NOX4, as well as surrogate markers for ROS, mitochondrial injury, and metabolic pathways, to assess disease severity and progression from early stages.
Participants in this study will have blood and urine samples collected to determine biomarkers of oxidative stress, antioxidant response, related metabolite levels, as well as kidney injury markers. In addition, an abdominal MRI will be performed to determine the patient's total kidney volume (TKV).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: