Observational study on early-stage polycystic kidney disease
Early PKD Observational Cohort Study
This study is collecting samples from people with early-stage polycystic kidney disease and their family members to find signs that show how the disease is changing, which could help create new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 4 Years to 35 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT02936791 on ClinicalTrials.gov |
What this trial studies
This observational study collects blood, urine, and clinical information from individuals with early-stage polycystic kidney disease (PKD), their unaffected siblings, and normal volunteers to create a biobank. The goal is to identify biomarkers that indicate changes in disease progression, particularly focusing on early renal cyst growth. By understanding these biomarkers, the study aims to enhance the development of new therapies for PKD before significant kidney function decline occurs.
Who should consider this trial
Good fit: Ideal candidates include individuals with early-stage autosomal dominant polycystic kidney disease and their unaffected siblings.
Not a fit: Patients with advanced kidney disease or those with systemic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and better management of polycystic kidney disease, ultimately improving patient outcomes.
How similar studies have performed: Other studies have explored biomarkers in PKD, but this specific approach focusing on early-stage disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois and 2 other locations
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Children's Mercy Hospital — Kansas City, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Alan SL Yu, MD — University of Kansas Medical Center
- Study coordinator: Cathy Creed, RN
- Email: ccreed@kumc.edu
- Phone: 913-588-0053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.