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

NCT01114594 | Completed

• 1 other identifier: 1003010924
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Polycystic Kidney, Autosomal Dominant

Keywords

Chronic Kidney Disease (CKD); Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Outcome Measures

Primary Outcomes (1)

• Identification of micro-RNA Biomarkers Associated with Autosomal Dominant Chronic Kidney Disease

  5 years

Study Arms (2)

PKD

Patients with Autosomal Dominant Polycystic Kidney Disease

non-PKD CKD

Patients with non-Polycystic Chronic Kidney Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

20 outpatients, 20 patients control

You may qualify if:

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

You may not qualify if:

• Presenting with any signs or symptoms of an infectious disease
• Bacterial infection determined by urine culture
• Use of systemic steroids within a week prior to screening
• 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.

Sponsors & Collaborators

• The Rogosin Institute: lead
• Rockefeller University: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

The Rogosin Institute

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, monocytes, urine

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Polycystic Kidney Diseases; Kidney Diseases, Cystic; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Officials

• Jon Blumenfeld, MD

  The Rogosin Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2010
• First Posted: May 3, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

US (1)