PKD Clinical and Translational Core Study

Phase

N/A

Condition

Kidney Failure (Pediatric)

Nephropathy

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT01873235

HP-00054815; 5P30DK090868-02

5P30DK090868

Ages > 18
All Genders

Study 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 Criteria

Inclusion

Inclusion criteria:

Age 18 and older
ADPKD confirmed by genetic testing or ultrasound criteria using modified Ravinecriteria: with family history:several cysts per kidney (3 by sonography, 5 if bycomputerized tomography or MRI)without family history: 10 cysts (by any radiologicmethod) per kidney and exclusion of other cystic kidney diseases
Ability to provide written informed consent prior to initiation of any studyprocedures and the ability in the opinion of the investigator to comply with allrequirements of the study
Glomerular Filtration Rate (GFR) greater than 15ml/min/1.73m2

Exclusion

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 morethan one oral hypoglycemic agent
Diabetic nephropathy

Study Design

March 01, 2013

June 30, 2027

Study 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 clinical phenotyping includes measurement of renal filtration function, total kidney volume, clinical and family history, presence and history of renal and extra-renal ADPKD manifestations, cardiac function, vascular stiffness, and health-related quality of life.

Prospective characterization will include the development of ADPKD complications (e.g., infection, stones, cyst hemorrhage) and other acute medical events, and changes in symptoms and QoL.

In addition, an electronic PKD patient registry will collect demographic and contact information on adults with ADPKD interested in participating in future clinical trials and/or observational cohort studies.

No treatment interventions will be performed in these observational studies

Connect with a study center

University of Maryland School of Medicine General Clinical Research Center
Baltimore, Maryland 21201
United States
Active - Recruiting

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