Status:
COMPLETED
A Study of RG-012 in Subjects With Alport Syndrome
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Alport Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is a Phase 1, multi-center study of the safety, pharmacodynamics, and pharmacokinetics of RG-012 administered to subjects with Alport syndrome. During this open-label study, all eligible subjects...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03373786
Start Date
December 22 2017
End Date
May 20 2019
Last Update
April 25 2022
Active Locations (7)
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1
eStudySite
La Mesa, California, United States, 91942
2
Academic Medical Research Institute
Los Angeles, California, United States, 90022
3
Apex Research of Riverside
Riverside, California, United States, 92505
4
Eminence Medical & Clinical Research
Tampa, Florida, United States, 33604