A Study of RG-012 in Subjects With Alport Syndrome

• Status: Completed
• Trial end date: 2019-05-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1, open-label, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of RG-012 administered to subjects with Alport syndrome.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company

Criteria

Inclusion Criteria:

1. Males or females, ages 18 to 65 years

2. Confirmed diagnosis of Alport syndrome

3. eGFR between 40 and 90 mL/min/1.73m2

4. Proteinuria of at least 300 mg protein/g creatinine

5. For subjects taking an ACE inhibitor or an ARB, the dosing regimen should be stable for at least 30 days prior to screening

6. Willing to comply with contraception requirements

Exclusion Criteria:

1. Causes of chronic kidney disease aside from Alport syndrome (such as diabetic nephropathy, hypertensive nephropathy, lupus nephritis, or IgA nephropathy)

2. End stage renal disease (ESRD) as evidenced by ongoing dialysis therapy or history of renal transportation

3. Any other condition that may pose a risk to the subject's safety and well-being

4. Female subjects who are pregnant or lactating