The Fabrazyme® and Arbs and ACE Inhibitor Treatment (FAACET) Study
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
The primary hypothesis is that titration of ACE inhibitor and Angiotensin Receptor Blockers
(ARBs)to reduce urine protein excretion to < 500 mg per day in Fabry Patients receiving
agalsidase beta therapy at 1 mg/kg every two weeks will slow the progression rate of decline
of glomerular filtration rate (GFR) compared to case controls drawn from the
Genzyme-sponsored Phase III extension study (GFR 60 to 125 ml/min/1.73 m², urine protein > 1
gram/day) or the Phase IV study (GFR 20 to 60 ml/min/1.73 m², urine protein > 0.5 gram/day).
After a 3 month initial Evaluation Phase, the patients will be followed during a 24 month
Observation Phase. FAACET is an open label, prospective observational study. The primary
objective is reduction of first morning urine protein/creatinine ratio to < 0.5 gram/gram.
The primary outcome measure is the regression slope of MDRD GFR with time in years