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)
Protocol No: 021FSGS16010 (DUPLEX Study)
Sponsor: Retrophin, Inc
Investigator: Rohit Pankhaniya, MD
You are invited to take part in a clinical research study. To help you make an informed decision whether to take part in this study, you should know the purpose of the study, the procedures, the benefits and risks, the discomforts and the precautions taken during the study. This process is called ‘informed consent’. Please take the time to read the following information carefully and discuss it with others. This consent form might contain words or information that you do not understand. You are free to ask the study doctor or study staff to explain any words or information that you do not clearly understand. You are free to ask questions throughout the course of the study in person or by calling the study doctor at the phone number provided on page one of this consent form.
If you decide to take part in this study, you will be asked to sign this informed consent form. You will be given a copy of the signed form to keep, and the original will stay at the study center.
Background, Purpose of Study
Focal Segmental Glomerulosclerosis (FSGS) is a rare disease that affects the kidneys in both adults and children. Kidneys are important to your health because they filter waste materials such as salts, toxins and water out of the blood. The waste is passed out of your body as urine (pee). FSGS causes scarring in parts of the kidney that filter these waste materials, allowing protein to leak into the urine. The leaking protein is a condition called proteinuria and it causes fluid to build up in the body. If the protein leaks for too long, it can eventually lead to kidney failure (kidneys stop working).
You are being asked to join this research study involving the investigational drug, sparsentan, because you have been diagnosed with FSGS. An investigational drug means that not all information is known about how the drug works in your body and it has not been approved by the Food and Drug Administration (FDA) for the treatment of FSGS.
Sparsentan blocks the action of angiotensin II, a hormone that controls blood pressure and may be harmful in the kidney. Other drugs with similar effects are already approved and available for patient use for different reasons, such as high blood pressure or kidney disease. Sparsentan also blocks the action of a hormone in the body called endothelin, which is known to be harmful to the kidney. As seen in a previous clinical study, sparsentan may lower the amount of protein in the urine.
The purpose of this study is to learn if sparsentan is safe and effective in lowering the amount of protein in the urine and in preserving kidney function. In this study, sparsentan will be compared to a drug called irbesartan. Irbesartan is approved by the U.S. Food and Drug Administration (FDA), the European Union (for adults only), and some other countries worldwide to treat high blood pressure and kidney disease caused by diabetes. Sometimes, it is also used to treat patients with proteinuria (high amount of protein in the urine); however, it is not approved for use in FSGS, and is use in this study is investigational.
Please download the ICF form to view the compensation table.