PKD Clinical and Translational Core Study
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
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2020|
|Estimated Primary Completion Date:||June 2020 (Final data collection date for primary outcome measure)|
This is an observational prospective cohort study of adults with autosomal dominant polycystic kidney disease (ADPKD) with estimated GFR at least 20 cc/min/1.73m2. There are no therapeutic interventions in this observational cohort study.
The purpose of this study is to establish a prospective observational cohort of 200 well-characterized adults with ADPKD, and an associated biorepository of DNA, plasma, serum, and urine. Baseline clinical phenotyping includes mesurement of renal filtration function, total kidney volume, clinical and family history, presence and history of renal and extra-renal ADPKD mainfestations, cardiac function, vascular stiffness, and health-related quality of life.
Prospective characterization will include the development of ADPKD complications (e.g., infection, stones, cyst hemorrhage) and other acute medical events, and changes in syptoms 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 and/or observational cohort studies.
No treatment interventions will be performed in these observational studies
Please refer to this study by its ClinicalTrials.gov identifier: NCT01873235
|Contact: Charalett E Diggs, RN, MSNemail@example.com|
|Contact: Karkleen Schuhartfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Karleen Schuhart 410-328-3727 firstname.lastname@example.org|
|Principal Investigator: Terry Watnick, MD|
|Sub-Investigator: Stephen Seliger, MD, MS|
|Principal Investigator:||Terry J Watnick, MD||University of Maryland|