NCT Number: NCT01873235
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=350) 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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Baltimore, Maryland, 21201, United States
Location status: Recruiting
Charalett Diggs, RN, MSN
CONTACT
Karleen Schuhart
CONTACT
Stephen Seliger, MD, MS
SUB_INVESTIGATOR
Terry Watnick, MD
PRINCIPAL_INVESTIGATOR
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 (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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
--Pregnant, lactating, or intention to get pregnant in next 6 weeks
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.
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).
Time frame: Annually up to 8 Year follow up to assess changes between time points
Self- reported Hospitalizations with medical record retrieval for verification
Contact information is provided by the study sponsor or research team.
Charalett E Diggs, RN, MSN
CONTACT
Karkleen Schuhart
CONTACT
University of Maryland, Baltimore
Other
The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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