Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT02936791

Conditions

Polycystic Kidney Disease

Eligibility Criteria

Sex: All

Age: 4 - 35

Healthy Volunteers: Accepted

Study Details

Brief summary:

This observational study will collect blood and urine and clinical information from individuals with early-stages of polycystic kidney disease (PKD), their unaffected siblings and normal volunteers to create a biobank, also called a biorepository. The long-term goal is to develop new knowledge on biological markers or biomarkers that indicate changes in the disease progression. An understanding of biomarkers for early renal cyst growth will benefit PKD patients as new therapies are being developed and tested.

Conditions

Polycystic Kidney Disease

Study ID

NCT02936791

Start date

Apr, 2016

Status verified date

Apr, 2026

Completion date

Jun, 2031

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Inclusion for early stage autosomal dominant polycystic kidney disease (ADPKD):

  • Family history of PKD
  • All races and ethnic groups
  • Glomerular filtration rate (GFR) >80 ml/min per 1.73 m2
  • Inclusion for Healthy Volunteers:

  • Male or female with no family history of kidney disease
  • All races and ethnic groups
  • Normal GFR

Exclusion Criteria:

  • Non-insulin or insulin-dependent diabetes mellitus
  • Systemic illness (i.e.systemic lupus erythematosus, vasculitis)
  • Unable to provide written informed consent
  • Unavailable for magnetic resonance imaging (MRI) and blood/urine collection

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Individuals diagnosed with PKD

Individuals that have been diagnosed and meet the study's definition of early stage PKD.

Individuals with a family history of PKD

Unaffected/ undiagnosed family members, preferably siblings, of participants with PKD

Normal individuals for the comparison

Normal volunteers with no family history of PKD or other kidney diseases.

Primary outcome measure

  • Collect blood and urine samples from affected and unaffected cohorts for basic and translational research [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Cathy Creed, RN

913-588-0053ccreed@kumc.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Arlene Chapman, MD

Achapman1@medicine.bsd.uchicago.edu

Principal Investigator:

Arlene Chapman, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Cathy Creed, RN

913-588-0053ccreed@kumc.edu

Darren P Wallace, PhD

913-588-3889dwallace@kumc.edu

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Megan Mains, BSN

816-760-5918mmmains@cmh.edu

Principal Investigator:

Laurel Willig, MD, MS

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Apr 27, 2026

Last verified

Apr, 2026

Keywords

  • autosomal dominant polycystic kidney disease
  • ADPKD
  • PKD biomarkers
  • Kidney Institute
  • University of Kansas Medical Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-04-27.