A Study of RG-012 in Subjects With Alport Syndrome

Completed · Phase 1

Conditions studied: Alport Syndrome

In brief

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.

Key facts

Study ID

NCT03373786

Run by

Genzyme, a Sanofi Company

People needed

4

Starts

2017-12-22

Expected to finish

2019-05-20

Last updated by the study team

2022-04-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females, ages 18 to 65 years
• Confirmed diagnosis of Alport syndrome
• eGFR between 40 and 90 mL/min/1.73m2
• Proteinuria of at least 300 mg protein/g creatinine
• For subjects taking an ACE inhibitor or an ARB, the dosing regimen should be stable for at least 30 days prior to screening
• Willing to comply with contraception requirements

You may not qualify if…

• Causes of chronic kidney disease aside from Alport syndrome (such as diabetic nephropathy, hypertensive nephropathy, lupus nephritis, or IgA nephropathy)
• End stage renal disease (ESRD) as evidenced by ongoing dialysis therapy or history of renal transportation
• Any other condition that may pose a risk to the subject's safety and well-being
• Female subjects who are pregnant or lactating

Where it is running

• eStudySite — La Mesa, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Apex Research of Riverside — Riverside, California, United States
• Eminence Medical & Clinical Research — Tampa, Florida, United States
• Houston Nephrology Research — Cypress, Texas, United States
• Utah Kidney Research Institute — Salt Lake City, Utah, United States
• Allegiance Research Specialists, LLC — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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