A Medication Study for Individuals with Alport Syndrome (AS) and Primary Steroid-Resistant Focal Segmental (FSGS)
Official Title
A multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis.
Purpose
The overall objective is to investigate to investigate how safe, how well tolerated, and how effective R3R01 is in treating uncontrolled proteinuria in patients with Alport syndrome and steroid-resistant Focal Segmental Glomerulosclerosis. All eligible participants will be enrolled to receive R3R01 over a treatment period of 12 weeks. The study will consist of 3 periods, including a screening period of 3 weeks, a treatment period of 12 weeks, and a follow up of period of 12 weeks.
Could this study be right for you?
You may be eligible to participate if:
- You are aged 18 years or older
- Female patients and female partners of male patients willing to not become pregnant for the duration of the study
- Have not had an organ transplant and/or on a organ transplant list
- Have high protein in urine Alport Syndrome (AS) specific:
- Have X-linked AS and autosomal recessive AS
- Confirmed diagnosis of AS by genetic testing or kidney biopsy
- Do not have another kidney disease
- FSGS specific:
- Not older than 75 years of age
- Primary Focal segmental glomerulosclerosis (FSGS) (not caused by other condition) that is confirmed by kidney biopsy or documentation of genetic mutation
- Steroid-resistance: previous steroid treatment without remission