PKD Clinical and Translational Core Study

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Brief Title

PKD Clinical and Translational Core Study

Official Title

The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study

Brief Summary

      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=250) 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.
    

Detailed Description

      The purpose of this study is to establish a prospective observational cohort of 250
      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]


Primary Outcome

Renal volume by MRI

Secondary Outcome

 Quality of Life Instruments

Condition

Polycystic Kidney Disease


Study Arms / Comparison Groups

 Main Cohort
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

250

Start Date

March 2013

Completion Date

June 2024

Primary Completion Date

June 2024

Eligibility Criteria

        Inclusion criteria:

          -  Age 18 and older

          -  ADPKD confirmed by genetic testing or ultrasound criteria using modified Ravine
             criteria: with family history:several cysts per kidney (3 by sonography, 5 if by
             computerized tomography or MRI)without family history: 10 cysts (by any radiologic
             method) per kidney and exclusion of other cystic kidney diseases

          -  Ability to provide written informed consent prior to initiation of any study
             procedures and the ability in the opinion of the investigator to comply with all
             requirements of the study

          -  Glomerular Filtration Rate (GFR) greater than 15ml/min/1.73m2

        Exclusion Criteria:

          -  End Stage Renal Disease or presently on dialysis or a prior kidney transplant

             --Pregnant, lactating, or intention to get pregnant in next 6 weeks

          -  Another systemic disease such as cancer or lupus

          -  Life expectancy less than 2 years

          -  Current participation in a drug treatment trial

          -  Non English speaking

          -  Uncontrolled diabetes A1C 7.0 or more within 6 months of study visit; and/or on more
             than one oral hypoglycemic agent

          -  Diabetic nephropathy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Terry J Watnick, MD, 410-706-2122, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01873235

Organization ID

HP-00054815; 5P30DK090868-02

Secondary IDs

5P30DK090868

Responsible Party

Principal Investigator

Study Sponsor

University of Maryland, Baltimore

Collaborators

 National Institutes of Health (NIH)

Study Sponsor

Terry J Watnick, MD, Principal Investigator, University of Maryland, College Park


Verification Date

September 2021