Falcon: Bardoxolone Methyl For Autosomal Dominant Polycystic Kidney Disease (Adpkd)
Posted Date: Oct 29, 2021
- Investigator: Shashi Kant
- Type of Study: Drug
The Falcon Trial will focus on the long-term safety and efficacy of bardoxolone methyl in ADPKD. The FALCON trial will enroll up to 550 patients and will evaluate patients on treatment for 2 years. It is placebo controlled, meaning that half of the participants will randomly be assigned to receive bardoxolone, and half will be randomly assigned to receive placebo. and neither the participant nor the doctor will know whether which study drug has been assigned. The experimental treatment during the study will be given in the form of an oral capsule taken once per day. The goal of this study is to evaluate the long-term safety and efficacy of the study drug bardoxolone methly by measuring eGFR compared to baseline at week 52 and at Week 104. The possible side effects of the medication are muscle spasms, allergic reactions, low magnesium levels, increases in liver enzymes which may be temporary. or fluid overload. Subjects are compensated for time in the study.
Subjects Must Have Adpkd As Assessed By Mri Or Ultrasound,. Egfr Must Be Between 30 And 90, But Also Depends On Subject Age. Subjects Must Be Willing To Come To Allstudy Visits, Take Study Medication And Measure And Record Their Weight Daily. Women Who Are Able To Become Pregnant, And Men Must Agree To Use Birth Control In Most Instances. Subjects Cannot Have History Or Intracranial Aneurysms, Recent Kidny Failure, Significant Heart Disease Or Active Infection. Subjects Cannot Be Taking Tolvaptan, Or Have Covid Within Last 6 Months..
Renal, Cysts, Ckd
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