PKD Biomarkers Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02936791|
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : May 21, 2019
|Condition or disease|
|Polycystic Kidney Disease|
In polycystic kidney disease (PKD), renal cysts form in utero and progressively enlarge due to aberrant proliferation of the cyst-lining cells and accumulation of fluid within the expanding cyst cavity. Over decades of unrelenting cyst growth, renal function declines due to the loss of functional tissue, eventually leading to kidney failure and the need for renal replacement therapy, such as dialysis or kidney transplantation.
Effective therapies for the treatment of PKD will need to be delivered as early as possible, before a measurable decline in kidney function, to preserve functional tissue. Currently, it is difficult to make an accurate prognosis of the progression of early-stage PKD since the growth of microscopic cysts is difficult to detect by standard imaging modalities and changes in total kidney volume measured within a reasonable time period are too small to be informative. Even though early cysts may not cause detectable changes in total kidney volume, their progressive enlargement damages the surrounding tissue and is a prelude to chronic kidney disease.
Current blood and urine tests provide important information on the decline of kidney function; however, these tests are not useful for monitoring early events of PKD such as initial cyst growth and damage to neighboring tissue. Clearly, novel biomarkers of early cystic disease need to be discovered to develop appropriate clinical tests to monitor the progression of early stage PKD. These tests will be important to identify patients at risk of rapid progression and of need of therapeutic intervention and to monitor the effectiveness of the therapeutic drug. The PKD Biomarkers Repository will allow approved researchers to obtain blood and urine samples for biomarker discovery and development of appropriate biomarker assays for prognosis of early PKD.
This observational study is currently recruiting for three groups: 1) individuals diagnosed with relatively early PKD as defined by total kidney volume and estimated GFR, 2) unaffected or undiagnosed family members, preferably siblings, 3) normal volunteers with no family history of renal disease.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||250 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Polycystic Kidney Disease (PKD) Biomarkers Study|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
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.
- Collect blood and urine samples from affected and unaffected cohorts for basic and translational research [ Time Frame: 5 years ]The study will establish a repository of blood and urine from individuals with early stage PKD, unaffected/undiagnosed family members and normal volunteers.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936791
|Contact: Cathy Creed, RNemail@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Serdar Aydin, MD 773-795-1256 firstname.lastname@example.org|
|Principal Investigator: Arlene Chapman, MD|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Darren P Wallace, PhD 913-588-3889 email@example.com|
|Contact: Cathy Creed, RN 913-588-0053 firstname.lastname@example.org|
|United States, Missouri|
|Children's Mercy Hospital||Recruiting|
|Kansas City, Missouri, United States, 64108|
|Contact: Marissa K Beidelschies, RN 816-701-1344 email@example.com|
|Principal Investigator: Laurel Willig, MD, MS|
|Principal Investigator:||Darren P Wallace, PhD||University of Kansas Medical Center|