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This study has been withdrawn prior to enrollment.
(Withdrawn and replaced with a revised study)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

June 13, 2012
November 13, 2013
July 2013
July 2014   (final data collection date for primary outcome measure)
Evaluate change in albumin excretion rate (AER) from baseline
Evaluate albumin creatinine ratio (ACR) between the low dose group, high dose group, and active control group. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

This is a Phase 3, randomized, double-blind, active-controlled, multi-center, international, fixed dose study with RE-021 in patients with biopsy-proven primary FSGS. Patients will enter a 12 week fixed dose study followed by a 2 week-off follow-up period.

Urine albumin/creatinine ratio must be above 1.0 as the screening visit. If this and all other enrty criteria are met, the patient will go through a two-week ARB and ACE washout period then randomized to one of three arms in a 3:1 ratio of RE-021 vs. active control (irbesartan 300 mg).

Complete list of historical versions of study NCT01622738 on ClinicalTrials.gov Archive Site
Not Provided
Compare the change in albumin creatinine ratio (ACR) from baseline achieved with multiple fixed doses of RE-021 to angiotensin receptor blocker (ARB) therapy after 12 weeks of treatment. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • The percentage of patients with reduction in albumin to creatinine ratio (ACR) from baseline of 30% or greater and 50% or greater at 12 weeks of treatment
  • Times to first observation of 30% and 50% reduction in ACR from baseline
  • Times to first observation of 30% and 50% reduction in ACR from baseline
  • The percent change in the effect on ACR on the primary endpoint at 14 weeks (2 weeks post treatment) compared to at the end of treatment at 12 weeks (reversiblity of effect)
  • Changes in serum albumin, total cholesterol, plasma renin, endothelin, and aldosterone
Not Provided
Not Provided
 
A Study of RE-021 in Patients With Focal Segmental Glomerulosclerosis
A Study of RE-021 in Patients With Focal Segmental Glomerulosclerosis

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

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Focal Segmental Glomerulosclerosis
Drug: RE-021
Experimental: RE-021
Intervention: Drug: RE-021
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2014
July 2014   (final data collection date for primary outcome measure)

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)

Both
up to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01622738
RET-D-002
No
Retrophin, Inc.
Retrophin, Inc.
Not Provided
Principal Investigator: Howard Trachtman, M.D. NYU MEDICAL CENTER
Retrophin, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP