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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114594
• Other study ID #: 1003010924
• Status: Completed
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2018
• Source: The Rogosin Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	The Rogosin Institute	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
The Rogosin Institute	Rockefeller University, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of micro-RNA Biomarkers Associated with Autosomal Dominant Chronic Kidney Disease		5 years