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

This study has been withdrawn prior to enrollment.
(Withdrawn and replaced with a revised study)
Sponsor:
Information provided by (Responsible Party):
Retrophin, Inc.
ClinicalTrials.gov Identifier:
NCT01622738
First received: June 13, 2012
Last updated: November 13, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Retrophin, Inc.:

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

Enrollment: 0
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
NYU School of Medicine - Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
Retrophin, Inc.
Investigators
Principal Investigator: Howard Trachtman, M.D. NYU MEDICAL CENTER
  More Information

Additional Information:
No publications provided

Responsible Party: Retrophin, Inc.
ClinicalTrials.gov Identifier: NCT01622738     History of Changes
Other Study ID Numbers: RET-D-002
Study First Received: June 13, 2012
Last Updated: November 13, 2013
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 October 02, 2014