PKD Clinical and Translational Core Study (PKD Core)
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 ADPKD,insufficient 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 (N=200) 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, plasma,urine 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.
Polycystic Kidney Disease
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||4 Years|
|Official Title:||The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study|
- Renal volume by MRI [ Time Frame: Baseline ] [ Designated as safety issue: No ]Calculations of the volume will be based on summation of the products of the area measurements of the kidneys and/or liver and slice thickness. A region-based signal threshold method will be applied to calculate total cyst volume, and the remaining parenchymal renal and hepatic volume.
- Quality of Life: [ Time Frame: Annually up to 4 years ] [ Designated as safety issue: No ]Self-reported Quality of Life (pain, anxiety, depression, physical activity, fatigue).
- Hospitalizations [ Time Frame: Annually up to 4 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Plasma, serum,urine, and DNA will be collected at the baseline visit and stored in a biorepository.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01873235
|Contact: Charalett E Diggs, RN, MSNfirstname.lastname@example.org|
|Contact: Karkleen Schuhartemail@example.com|
|United States, Maryland|
|University of Maryland School of Medicine General Clinical Research Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Charalett Diggs, RN, MSN 410-328-0207 firstname.lastname@example.org|
|Contact: Karleen Schuhart 410-328-3727 email@example.com|
|Principal Investigator: Terry Watnick, MD|
|Sub-Investigator: Stephen Seliger, MD, MS|
|Principal Investigator:||Terry J Watnick, MD||University of Maryland|