Status:
RECRUITING
PKD Clinical and Translational Core Study
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Polycystic Kidney Disease
Eligibility:
All Genders
18+ years
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 cli...
Detailed Description
The purpose of this study is to establish a prospective observational cohort of 350 well-characterized adults with ADPKD, and an associated biorepository of DNA, plasma, serum, and urine. Baseline cli...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01873235
Start Date
March 1 2013
End Date
June 1 2030
Last Update
September 11 2025
Active Locations (1)
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1
University of Maryland School of Medicine General Clinical Research Center
Baltimore, Maryland, United States, 21201