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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
History of Changes
  Purpose

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.


Condition
Chronic Kidney Disease
Polycystic Kidney, Autosomal Dominant

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study of RNA as a Biomarker for Autosomal Dominant Polycystic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Rogosin Institute:

Biospecimen Retention:   Samples With DNA

Plasma, serum, monocytes, urine


Enrollment: 42
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
PKD
Patients with Autosomal Dominant Polycystic Kidney Disease
non-PKD CKD
Patients with non-Polycystic Chronic Kidney Disease

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

20 outpatients, 20 patients control

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01114594

Locations
United States, New York
The Rogosin Institute
New York, New York, United States, 10021
Sponsors and Collaborators
The Rogosin Institute
Rockefeller University
Weill Medical College of Cornell University
Investigators
Principal Investigator: Jon Blumenfeld, MD The Rogosin Institute
  More Information

No publications provided

Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT01114594     History of Changes
Other Study ID Numbers: 1003010924
Study First Received: April 26, 2010
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Rogosin Institute:
Chronic Kidney Disease (CKD)
Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Renal Insufficiency, Chronic
 Kidney Failure, Chronic
Urologic Diseases
Kidney Diseases, Cystic
Renal Insufficiency

ClinicalTrials.gov processed this record on June 18, 2013