PKD Clinical and Translational Core Study
- Conditions
- Polycystic Kidney Disease
- Registration Number
- NCT01873235
- Lead Sponsor
- University of Maryland, Baltimore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 350
<br><br> - Age 18 and older<br><br> - ADPKD confirmed by genetic testing or ultrasound criteria using modified Ravine<br> criteria: with family history:several cysts per kidney (3 by sonography, 5 if by<br> computerized tomography or MRI)without family history: 10 cysts (by any radiologic<br> method) per kidney and exclusion of other cystic kidney diseases<br><br> - Ability to provide written informed consent prior to initiation of any study<br> procedures and the ability in the opinion of the investigator to comply with all<br> requirements of the study<br><br> - Glomerular Filtration Rate (GFR) greater than 15ml/min/1.73m2<br><br>Exclusion Criteria:<br><br> - End Stage Renal Disease or presently on dialysis or a prior kidney transplant<br><br> --Pregnant, lactating, or intention to get pregnant in next 6 weeks<br><br> - Another systemic disease such as cancer or lupus<br><br> - Life expectancy less than 2 years<br><br> - Current participation in a drug treatment trial<br><br> - Non English speaking<br><br> - Uncontrolled diabetes A1C 7.0 or more within 6 months of study visit; and/or on more<br> than one oral hypoglycemic agent<br><br> - Diabetic nephropathy
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Renal volume by MRI
- Secondary Outcome Measures
Name Time Method Quality of Life Instruments