Trial record 1 of 2 for:    PKD Core
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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. Identifier: NCT01873235
Recruitment Status : Recruiting
First Posted : June 10, 2013
Last Update Posted : April 12, 2018
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Terry Watnick, University of Maryland

May 23, 2013
June 10, 2013
April 12, 2018
March 2013
June 2020   (Final data collection date for primary outcome measure)
Renal volume by MRI [ Time Frame: Baseline ]
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.
Same as current
Complete list of historical versions of study NCT01873235 on Archive Site
Quality of Life: [ Time Frame: Annually up to 4 years ]
Self-reported Quality of Life (pain, anxiety, depression, physical activity, fatigue).
Same as current
Hospitalizations [ Time Frame: Annually up to 4 years ]
Same as current
PKD Clinical and Translational Core Study
The Baltimore Polycystic Kidney Disease 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.

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

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
8 Years
Retention:   Samples With DNA
Plasma, serum,urine, and DNA will be collected at the baseline visit and stored in a biorepository.
Non-Probability Sample
Adults with diagnosed Polycystic Kidney Disease
Polycystic Kidney Disease
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2020
June 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact: Charalett E Diggs, RN, MSN 410-328-0207
Contact: Karkleen Schuhart 410-328-3727
United States
HP-00054815; 5P30DK090868-02
5P30DK090868 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Terry Watnick, University of Maryland
University of Maryland
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Terry J Watnick, MD University of Maryland
University of Maryland
April 2018