Early PKD Observational Cohort Study

ConditionPolycystic Kidney Disease

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age4-35

SponsorUniversity of Kansas Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants

are grouped into 3 trial groups

Group A: Individuals diagnosed with PKD

Group B: Individuals with a family history of PKD

Group C: Normal individuals for the comparison

Trial outcomes

Primary outcomes

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.

Time frame

10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Kansas Medical Center

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov

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