PKD Clinical and Translational Core Study (PKD Core)

Maryland

Overview

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.

 

Participant information: Biosamples will be collected and stored (plasma, serum, urine, and DNA), and participants will be asked to visit the clinic for a baseline and year 3 in-person study visit. Follow-up by phone will then occur every 6 months through year 8 of participation.

Inclusion criteria:

  • 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) more than 15 ml/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

 

 

Contact information at the University of Maryland:

Charalett E. Diggs, RN MSN
410.706.2122
cdiggs@medicine.umaryland.edu

Karleen Schuhart
410.328.3727
kschuhart@medicine.umaryland.edu