Pilot Study of RNA as a Biomarker for Autosomal Dominant Polycystic Kidney Disease

This study has been completed.
Sponsor:
Collaborators:
Rockefeller University
Weill Medical College of Cornell University
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT01114594
First received: April 26, 2010
Last updated: August 9, 2012
Last verified: August 2012

April 26, 2010
August 9, 2012
April 2010
April 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01114594 on ClinicalTrials.gov Archive Site
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Pilot Study of RNA as a Biomarker for Autosomal Dominant Polycystic Kidney Disease
Pilot Study of RNA as a Biomarker for Autosomal Dominant Polycystic Kidney Disease

The aim of this pilot project is to assess the potential of urine micro-RNAs (miRNA) as biomarkers for characterizing patients with autosomal dominant polycystic kidney disease (ADPKD) compared with patients with other causes of chronic kidney disease.

Proteins and small molecules in urine (biomarkers) have been used to probe for kidney and systemic diseases for hundreds of years. Urine reportedly contains a type of molecule called microRNA (miRNAs) that regulate a large number of biological processes. Impaired function of miRNAs is now recognized in an increasing number of disease processes. In the search for new biomarkers, the regulatory function of miRNAs and the relative simplicity and precision of characterizing miRNAs, are potential advantages when compared to traditional biomarkers.

The aim of this pilot project is to assess the potential of urine miRNAs as biomarkers for characterizing patients with autosomal dominant polycystic kidney disease (ADPKD), the most prevalent inherited cause of kidney failure. Individuals with other causes of chronic kidney disease (e.g., diabetes, glomerulonephritis), who are matched for key characteristics (e.g. age, sex, level of kidney function) will serve as the control population. A technique for isolation of miRNAs from urine samples will be tailored for the specific needs of this project. Biochemical and computational analysis of small RNAs from these samples will provide urine miRNA profiles and key variability statistics that will be use to design follow-up projects involving patients with kidney disease.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma, serum, monocytes, urine

Probability Sample

20 outpatients, 20 patients control

  • Chronic Kidney Disease
  • Polycystic Kidney, Autosomal Dominant
Not Provided
  • PKD
    Patients with Autosomal Dominant Polycystic Kidney Disease
  • non-PKD CKD
    Patients with non-Polycystic Chronic Kidney Disease
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male or female subject, 18 years of age or older, with diagnosis of ADPKD or non-PKD-CKD
  2. If female, not pregnant.
  3. Willing and able to understand and sign informed consent

Exclusion Criteria:

  1. Presenting with any signs or symptoms of an infectious disease
  2. Bacterial infection determined by urine culture
  3. Use of systemic steroids within a week prior to screening
  4. History, physical, or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the Principal Investigator, make the candidate ineligible for the study.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114594
1003010924
No
The Rogosin Institute
The Rogosin Institute
  • Rockefeller University
  • Weill Medical College of Cornell University
Principal Investigator: Jon Blumenfeld, MD The Rogosin Institute
The Rogosin Institute
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP