RecruitingNCT01873235

PKD Clinical and Translational Core Study

The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study


Sponsor

University of Maryland, Baltimore

Enrollment

350 participants

Start Date

Mar 1, 2013

Study Type

OBSERVATIONAL

Conditions

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=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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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Locations(1)

University of Maryland School of Medicine General Clinical Research Center

Baltimore, Maryland, United States

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NCT01873235


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