Early PKD Observational Cohort Study

NCT02936791 | Recruiting

• 2 other identifiers: STUDY00146013U54DK126126
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Collect blood and urine samples from affected and unaffected cohorts for basic and translational research

  The study will establish a repository of blood and urine from individuals with early stage PKD, unaffected/undiagnosed family members and normal volunteers.

  10 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 4 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The Study Population will include individuals clinically diagnosed with PKD and meet the inclusion criteria, their family members with not been diagnosed or have been determined not to have cysts within their kidneys and normal volunteers that will serve as a control group for the study.

You may qualify if:

• Family history of PKD
• All races and ethnic groups
• Glomerular filtration rate (GFR) \>80 ml/min per 1.73 m2
• Male or female with no family history of kidney disease
• All races and ethnic groups
• Normal GFR

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

Related Links

• PKD Biomarkers Repository Study

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples are being collected from study participants. Researchers will only receive de-identified samples. No identifies will be given to investigators.

MeSH Terms

Conditions

Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant

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

• Alan SL Yu, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Darren P Wallace, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Creed, RN

CONTACT

913-588-0053; ccreed@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 18, 2016
• Study Start: April 1, 2016
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)