PKD Clinical and Translational Core Study

NCT01873235 | Recruiting

• 2 other identifiers: HP-00054815; P30DK09085P30DK090868
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Polycystic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Renal volume by MRI

  Calculations of the volume will be based on summation of the products of the area measurements of the kidneys and/or liver and slice thickness. A region-based signal threshold method will be applied to calculate total cyst volume, and the remaining parenchymal renal and hepatic volume.

  Baseline and 3 Year follow up measures to assess changes between the time points

Secondary Outcomes (1)

• Quality of Life Instruments

  Annually up to 3 Year follow up measures to assess changes between the time points

Other Outcomes (1)

• Hospitalizations

  Annually up to 8 Year follow up to assess changes between time points

Study Arms (1)

Main Cohort

This is an observational prospective cohort study of adults with autosomal dominant polycystic kidney disease (ADPKD) with estimated GFR at least 15cc/min/1.73m2. There are no therapeutic interventions in this observational cohort study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with diagnosed Polycystic Kidney Disease

You may qualify if:

• Age 18 and older
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Maryland School of Medicine General Clinical Research Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Links

• Baltimore PKD Core Center

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum,urine, and DNA will be collected at the baseline visit and stored in a biorepository.

MeSH Terms

Conditions

Polycystic Kidney Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Terry J Watnick, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charalett E Diggs, RN, MSN

CONTACT

410-706-2122; charalett.diggs@som.umaryland.edu

Karkleen Schuhart

CONTACT

410-706-3455; kschuhart@som.umaryland.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: June 10, 2013
• Study Start: March 1, 2013
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)