Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glo… (NCT01613118) | Clinical Trial Compass
CompletedPhase 2
Randomized, Double-Blind, Safety and Efficacy Study of RE-021 (Sparsentan) in Focal Segmental Glomerulosclerosis
United States109 participantsStarted 2014-03
Plain-language summary
This study will investigate whether RE-021 (Sparsentan), a selective dual-acting receptor antagonist with affinity for endothelin (A type) and angiotensin II receptors (Type 1), is safe and effective in treating patients with focal segmental glomerulosclerosis (FSGS).
Who can participate
Age range8 Years – 75 Years
SexALL
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Inclusion criteria
✓. Biopsy-proven FSGS OR documentation of a genetic mutation in a podocyte protein associated with the disease.
✓. Urine protein/creatinine ratio (Up/C) at or above 1.0 g/g.
✓. Mean seated blood pressure (BP) \>100/60 mmHg and \<145/95 in patients \>/= 18 years of age. Mean seated BP for patients \<18 years of age should be \>90/60 mmHg and \<95th percentile for age, gender, and height.
✓. If a patient is taking immunosuppressive medications (except for Rituximab or cyclophosphamide), the dose and/or levels must be stable for 1 month prior to randomization and the Investigator should not have plans to alter the regimen during the first 8 weeks of treatment, except to stabilize levels. Patients on Rituximab or cyclophosphamide will be eligible provided they have not been taking these medications for 3 months prior to randomization.
✓. US Sites: Males or females 8 to 75 years of age willing and able to provide written informed consent and/or assent, with informed consent signed by patient or parent/legal guardian.
✓. EU Sites: Males or females 18 to 75 years of age willing and able to provide written informed consent, with informed consent, signed by patient or legal guardian.
Exclusion criteria
✕. Patients with FSGS secondary to another condition.
✕. Patients with history of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (HBA1c\>8%), or non-fasting blood glucose \>180 mg/dL at screening.
✕. Patients with a requirement for any of the medications indicated on the list of Excluded Medications, with the exception of ACE and ARBs.
✕. Patients with a documented history of heart failure (NYHA Class II-IV), and / or previous hospitalization for heart failure or unexplained dyspnea, orthopnea, paroxysmal nocturnal dyspnea, ascites and peripheral edema. Patients with clinically significant cerebrovascular disease (transient ischemic attack or stroke) and/or coronary artery disease (hospitalization for myocardial infarction or unstable angina, new onset of angina with positive functional tests or coronary angiogram revealing stenosis, coronary revascularization procedure) within 6 months before screening.
✕. Patients with clinically significant cardiac conduction defects, including second or third degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.
✕. Patients with jaundice, hepatitis, or known hepatobiliary disease (includes asymptomatic cholelithiasis); alanine aminotransferase and/or aspartate aminotransferase \>2 times the upper limit of normal at Screening.
✕. Patients positive for human immunodeficiency virus (HIV), and markers indicating acute (positivity of at least one of the following: Hepatitis B surface antigen \[HBsAg\], Hepatitis B "e" antigen \[HBeAg\], Hepatitis B virus \[HBV\] DNA in blood or liver, Immunoglobulin M Hepatitis B core antibody) or chronic (HBsAg and/or HBeAg and/or Hepatitis B virus \[HBV\] DNA positivity) HBV infection, or hepatitis C virus (HCV) infection (reactive anti-HCV antibody and/or HCV RNA). Testing at screening is only required for patients \>/= 18 years of age.