021FSG16010 - DUPLEX, Patients with FSGS

• Research type

  Research Study

• Full title

  A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PARALLEL, ACTIVE-CONTROL STUDY OF THE EFFECTS OF SPARSENTAN, A DUAL ENDOTHELIN RECEPTOR AND ANGIOTENSIN RECEPTOR BLOCKER, ON RENAL OUTCOMES IN PATIENTS WITH PRIMARY FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)

• IRAS ID

  243749

• Contact name

  Jonathan Barratt

• Contact email

  jonathan.barratt@uhl-tr.nhs.uk

• Sponsor organisation

  Retrophin, Inc.

• Eudract number

  2016-005141-23

• Clinicaltrials.gov Identifier

  NCT03493685

• Duration of Study in the UK

  3 years, 9 months, 10 days

• Research summary

  This is a phase 3 study to determine if the investigational drug sparsentan is safe and effective in lowering the amount of protein in the urine. In this study, sparsentan will be compared to the drug irbesartan which is a drug approved by the United States (U.S.) Food and Drug Administration (FDA), the European Union, and some other countries worldwide to treat high blood pressure and kidney disease caused by diabetes.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  18/EM/0193

• Date of REC Opinion

  30 Jul 2018

• REC opinion

  Further Information Favourable Opinion