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Trial record 3 of 7209 for:    "Kidney Diseases"

Early-Stage Polycystic Kidney Disease Biomarkers Repository Study

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ClinicalTrials.gov Identifier: NCT02936791
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease
Polycystic Kidney Disease

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Polycystic Kidney Disease (PKD) Biomarkers Repository Study
Study Start Date : April 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Group/Cohort
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 Measures :
  1. 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
Blood and urine samples are being collected from study participants. Researchers will only receive de-identified samples. No identifies will be given to investigators.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

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


Contacts
Contact: Cathy Creed, RN 913-588-0053 ccreed@kumc.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Brittany Ray    773-702-9865    bray10@medicine.bsd.uchicago.edu   
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    dwallace@kumc.edu   
Contact: Cathy Creed, RN    913-588-0053    ccreed@kumc.edu   
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Suzanne Herd    816-701-1344    smherd@cmh.edu   
Principal Investigator: Laurel Willig, MD, MS         
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Darren P Wallace, PhD University of Kansas Medical Center

Additional Information:
Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02936791     History of Changes
Other Study ID Numbers: STUDY00003383
P30DK106912 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Kansas Medical Center:
autosomal dominant polycystic kidney disease
ADPKD
PKD biomarkers
Kidney Institute
University of Kansas Medical Center

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn