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PKD Clinical and Translational Core Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by University of Maryland
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01873235
First received: May 23, 2013
Last updated: December 1, 2015
Last verified: December 2015

May 23, 2013
December 1, 2015
March 2013
June 2020   (final data collection date for primary outcome measure)
Renal volume by MRI [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov Archive Site
Quality of Life: [ Time Frame: Annually up to 4 years ] [ Designated as safety issue: No ]
Self-reported Quality of Life (pain, anxiety, depression, physical activity, fatigue).
Same as current
Hospitalizations [ Time Frame: Annually up to 4 years ] [ Designated as safety issue: No ]
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 mesurement of renal filtration function, total kidney volume, clinical and family history, presence and history of renal and extra-renal ADPKD mainfestations, 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 syptoms 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
4 Years
Retention:   Samples With DNA
Description:
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 20 cc/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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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
Both
18 Years and older   (Adult, Senior)
No
Contact: Charalett E Diggs, RN, MSN 410-328-0207 cdiggs@medicine.umaryland.edu
Contact: Karkleen Schuhart 410-328-3727 kschuhart@medicine.umaryland.edu
United States
 
NCT01873235
5P30DK090868-02, 5P30DK090868
No
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
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP