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A Study of RE-021 in Patients With Focal Segmental Glomerulosclerosis

This study is not yet open for participant recruitment.
Verified July 2012 by Retrophin, LLC.
Sponsor:
Information provided by (Responsible Party):
Retrophin, LLC.
ClinicalTrials.gov Identifier:
NCT01622738
First received: June 13, 2012
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

This is a study to investigate RE-021 in patients with focal segmental glomerulosclerosis (FSGS)


Condition Intervention
Primary Focal Segmental Glomerulosclerosis
 Drug: RE-021

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Study of RE-021 in Patients With Focal Segmental Glomerulosclerosis

Further study details as provided by Retrophin, LLC.:

Primary Outcome Measures:
  • Evaluate change in albumin excretion rate (AER) from baseline

Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RE-021 Drug: RE-021

  Eligibility

Ages Eligible for Study:   up to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Biopsy-proven primary FSGS (Primary FSGS confirmed by renal biopsy report OR documentation of a genetic mutation in a podocyte protein associated with the disease)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622738

Contacts
Contact: Christopher S. James, M.D. 646-495-5077 chris.james@retrophin.com

Locations
United States, New York
NYU School of Medicine - Langone Medical Center Not yet recruiting
New York, New York, United States, 10016
Contact: Howard Trachtman, M.D.     646-501-2663     howard.trachtman@nyumc.com    
Contact: Suzanne Vento, R.N.     646-501-2663     suzanne.vento@nyumc.com    
Principal Investigator: Howard Trachtman, M.D.            
Sponsors and Collaborators
Retrophin, LLC.
Investigators
Principal Investigator: Howard Trachtman, M.D. NYU MEDICAL CENTER
  More Information

Additional Information:
Sponsor's Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Retrophin, LLC.
ClinicalTrials.gov Identifier: NCT01622738     History of Changes
Other Study ID Numbers: RET-D-002
Study First Received: June 13, 2012
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013