PKD Clinical and Translational Core Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01873235|
Recruitment Status : Recruiting
First Posted : June 10, 2013
Last Update Posted : September 6, 2019
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.
|Condition or disease|
|Polycystic Kidney Disease|
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 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 (e.g., 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 and/or observational cohort studies.
No treatment interventions will be performed in these observational studies
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||8 Years|
|Official Title:||The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
This is an observational prospective cohort study of adults with autosomal dominant polycystic kidney disease (ADPKD) with estimated GFR at least 15cc/min/1.73m2. There are no therapeutic interventions in this observational cohort study.
- Renal volume by MRI [ Time Frame: Baseline and 3 Year follow up measures to assess changes between the time points ]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 Instruments [ Time Frame: Annually up to 3 Year follow up measures to assess changes between the time points ]Self-reported Quality of Life (pain, anxiety, depression, physical activity, fatigue).
- Hospitalizations [ Time Frame: Annually up to 8 Year follow up to assess changes between time points ]Self- reported Hospitalizations with medical record retrieval for verification
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 410-706-2122 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, College Park|