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PKD Clinical and Translational Core Study

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ClinicalTrials.gov Identifier: NCT01873235
Recruitment Status : Recruiting
First Posted : June 10, 2013
Last Update Posted : November 6, 2020
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, Baltimore

Study Description
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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.


Condition or disease
Polycystic Kidney Disease

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Years
Official Title: The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study
Study Start Date : March 2013
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Renal volume by MRI [ 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.


Secondary Outcome Measures :
  1. Quality of Life Instruments [ 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).


Other Outcome Measures:
  1. Hospitalizations [ Time Frame: Annually up to 8 Year follow up to assess changes between time points ]
    Self- reported Hospitalizations with medical record retrieval for verification


Biospecimen Retention:   Samples With DNA
Plasma, serum,urine, and DNA will be collected at the baseline visit and stored in a biorepository.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with diagnosed Polycystic Kidney Disease
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873235


Contacts
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Contact: Charalett E Diggs, RN, MSN 410-706-2122 charalett.diggs@som.umaryland.edu
Contact: Karkleen Schuhart 410-328-3727 kschuhart@som.umaryland.edu

Locations
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United States, Maryland
University of Maryland School of Medicine General Clinical Research Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Charalett Diggs, RN, MSN    410-706-2122    charalett.diggs@som.umaryland.edu   
Contact: Karleen Schuhart    410-328-3727    kschuhart@som.umaryland.edu   
Principal Investigator: Terry Watnick, MD         
Sub-Investigator: Stephen Seliger, MD, MS         
Sponsors and Collaborators
University of Maryland, Baltimore
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Terry J Watnick, MD University of Maryland, College Park
More Information
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Additional Information:

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Responsible Party: Terry Watnick, Principal Investigator, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT01873235    
Other Study ID Numbers: HP-00054815; 5P30DK090868-02
5P30DK090868 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Urologic Diseases
Kidney Diseases, Cystic
 Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn