PKD Clinical and Translational Core Study
ConditionPolycystic Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
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=350) 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
End Stage Renal Disease or presently on dialysis or a prior kidney transplant
Another systemic disease such as cancer or lupus
Life expectancy less than 2 years
Current participation in a drug treatment trial
Trial population
Adults with diagnosed Polycystic Kidney Disease
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
350 Participants
are grouped into 1 trial groupGroup A: Main Cohort
Trial outcomes
Primary outcomes
1
Renal volume by MRI
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.
Time frame
Baseline and 3 Year follow up measures to assess changes between the time pointsSecondary outcomes
1
Quality of Life Instruments
Self-reported Quality of Life (pain, anxiety, depression, physical activity, fatigue).
Time frame
Annually up to 3 Year follow up measures to assess changes between the time pointsOther outcomes
1
Hospitalizations
Self- reported Hospitalizations with medical record retrieval for verification
Time frame
Annually up to 8 Year follow up to assess changes between time pointsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov