Ignite Creation Date:
2024-05-06 @ 1:41 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01873235
Status:
RECRUITING
Last Update Posted:
2023-08-15
First Post:
2013-05-23
Brief Title:
PKD Clinical and Translational Core Study
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Advances in our understanding of the pathogenesis of autosomal dominant polycystic kidney disease ADPKD have opened up possibilities of new therapies to prevent disease progression High quality clinical investigations in patients with ADPKD however pose significant challenges to investigators including limited access to patients with ADPKDinsufficient guidance by experienced investigators and lack of resources to conduct these studies
The Polycystic Kidney Disease Research Clinical and Translational Core P30 aims to establish an infrastructure that will assist investigators in designing and conducting highest quality clinical and translational research focused on a diverse group of patients with ADPKD
Objective 1 To establish a Mid-Atlantic cohort of ADPKD patients N350 with baseline clinical phenotyping performed at the General Clinical Research Unit of the University of Maryland School of Medicine
Objective 2 To establish a state-of-the-art biobank of specimens from the ADPKD cohort including serum plasmaurine and DNA
Objective 3 To develop a collaborative network of physicians and practices in the Mid-Atlantic region who will contribute to the ADPKD cohort and will be willing to refer patients for future studies and trials
Objective 4 To establish a web-based registry of ADPKD patients in the Mid-Atlantic area
The Polycystic Kidney Disease Research Clinical and Translational Core P30 aims to establish an infrastructure that will assist investigators in designing and conducting highest quality clinical and translational research focused on a diverse group of patients with ADPKD
Objective 1 To establish a Mid-Atlantic cohort of ADPKD patients N350 with baseline clinical phenotyping performed at the General Clinical Research Unit of the University of Maryland School of Medicine
Objective 2 To establish a state-of-the-art biobank of specimens from the ADPKD cohort including serum plasmaurine and DNA
Objective 3 To develop a collaborative network of physicians and practices in the Mid-Atlantic region who will contribute to the ADPKD cohort and will be willing to refer patients for future studies and trials
Objective 4 To establish a web-based registry of ADPKD patients in the Mid-Atlantic area
Detailed Description:
The purpose of this study is to establish a prospective observational cohort of 350 well-characterized adults with ADPKD and an associated biorepository of DNA plasma serum and urine Baseline clinical phenotyping includes measurement of renal filtration function total kidney volume clinical and family history presence and history of renal and extra-renal ADPKD manifestations cardiac function vascular stiffness and health-related quality of life
Prospective characterization will include the development of ADPKD complications eg infection stones cyst hemorrhage and other acute medical events and changes in symptoms and QoL
In addition an electronic PKD patient registry will collect demographic and contact information on adults with ADPKD interested in participating in future clinical trials andor observational cohort studies
No treatment interventions will be performed in these observational studies
Prospective characterization will include the development of ADPKD complications eg infection stones cyst hemorrhage and other acute medical events and changes in symptoms and QoL
In addition an electronic PKD patient registry will collect demographic and contact information on adults with ADPKD interested in participating in future clinical trials andor observational cohort studies
No treatment interventions will be performed in these observational studies
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5P30DK090868 | NIH | None | httpsreporternihgovquickSearch5P30DK090868 |