The aim of this Phase 2a study is to explore if BAY 3401016 can reduce the decline of kidney function in participants with Alport syndrome who are at risk of fast disease progression. The study will also investigate the safety of repeat dose administration of BAY 3401016 in this population.
ASSESS (Alport Syndrome Sema3A Efficacy & Safety Study)
A randomized, double-blind, placebo-controlled, parallel group Phase 2a study with an extension phase to evaluate the efficacy and safety of BAY 3401016 in participants aged 18 to 45 with Alport syndrome.
Alport's syndrome
All genders
18-45
Overview
Principal Investigator: Lesley Inker, MD, MS
Contact Us
Kshitij Prabhune
Study details
Inclusion Criteria
- Participants must be 18 to 45 years of age inclusive, at the time of signing the informed consent
- Participants with AS:
• XLAS (male) or
• ARAS (male or female)
Diagnosis of AS confirmed by an experienced investigator based on available data from e.g. genetic testing, kidney biopsy, family history or other relevant clinical evidence in the medical records of the participant - eGFR ≥ 45 mL/min/1.73m2
(calculated by CKD-EPI Creatinine Equation (Inker et al 2021)) at screening
Exclusion Criteria
- Primary cause for chronic kidney disease is different from AS (e.g. diabetic, IgA, lupus, hypertensive or immune nephropathy) as assessed by the investigator.
- ESRD defined by prior renal transplantation or the need for renal replacement therapy by hemodialysis
- Clinically significant illness that could have influence on the safety of the participant and/or interfere with the study objectives
Study Requirements
- Number of research visits: 8-10; if subject opts for open label, then additional 5-6 visits.
- Length of participation: 44 weeks (screening, treatment and follow-up period); 68 weeks (with open label)
- Blood draw at each visit