PKD Clinical and Translational Core Study (PKD Core)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Maryland
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Terry Watnick, University of Maryland
ClinicalTrials.gov Identifier:
NCT01873235
First received: May 23, 2013
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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.


Condition
Polycystic Kidney Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Other Outcome Measures:
  • Hospitalizations [ Time Frame: Annually up to 4 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, serum,urine, and DNA will be collected at the baseline visit and stored in a biorepository.


Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Main Cohort

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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) less than 20ml/min/1.73m2

Exclusion Criteria:

  • End Stage Renal Disease or presently on dialysis or a prior kidney transplant
  • Inability to undergo MRI due to any reason including presence of pacemaker and defibrillator
  • Allergy to contrast or iodine
  • Pregnant, lactating, or intention to get pregnant in next 6 weeks
  • Another systemic disease such as diabetes or lupus
  • Life expectancy less than 2 years
  • Current participation in a drug treatment trial
  • Non English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01873235

Contacts
Contact: Charalett E Diggs, RN, MSN 410-328-0207 cdiggs@medicine.umaryland.edu
Contact: Karkleen Schuhart 410-328-3727 kschuhart@medicine.umaryland.edu

Locations
United States, Maryland
University of Maryland School of Medicine General Clinical Research Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Charalett Diggs, RN, MSN    410-328-0207    cdiggs@medicine.umaryland.edu   
Contact: Karleen Schuhart    410-328-3727    kschuhart@medicine.umaryland.edu   
Principal Investigator: Terry Watnick, MD         
Sub-Investigator: Stephen Seliger, MD, MS         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Terry J Watnick, MD University of Maryland
  More Information

Additional Information:
No publications provided

Responsible Party: Terry Watnick, Principal Investigator, University of Maryland
ClinicalTrials.gov Identifier: NCT01873235     History of Changes
Other Study ID Numbers: 5P30DK090868-02
Study First Received: May 23, 2013
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Multicystic Dysplastic Kidney
Urologic Diseases
Kidney Diseases, Cystic
Urogenital Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 18, 2014