PKD Clinical and Translational Core Study

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT01873235
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 31, 2013
Status verified
Sep 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
350 participants (estimated)

Arms

  • Arm: Main Cohort
    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.

Primary Outcome Measure

Renal volume by MRI [ Time Frame: Baseline and 3 Year follow up measures to assess changes between the time points ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland School of Medicine General Clinical Research CenterBaltimoreMaryland21201
Charalett Diggs, RN, MSN
[email protected]
410-706-2122
Karleen Schuhart
[email protected]
410-706-3455
Terry Watnick, MD (PRINCIPAL_INVESTIGATOR)
Stephen Seliger, MD, MS (SUB_INVESTIGATOR)

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University of Maryland School of Medicine General Clinical Research Center· Baltimore, MD

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