Status:
COMPLETED
The Fabrazyme® and Arbs and ACE Inhibitor Treatment (FAACET) Study
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Fabry Disease
Proteinuria
Eligibility:
All Genders
19-85 years
Brief 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 the...
Detailed Description
TITLE: FABRAZYME® + ARBS + ACE INHIBITOR TREATMENT (FAACET) STUDY Multi-center, Open-label Study of the Safety and Efficacy of Control of Proteinuria with Angiotensin Receptors Blockers (ARBs) and Ang...
Eligibility Criteria
Inclusion
- The patient must provide written, informed consent, and be ≥ 19 yrs of age.
- The patient is already receiving Fabrazyme® at 1 mg/kg every two weeks at the time of enrollment.
- Patient has confirmed Fabry disease (plasma αGAL activity of \< 1.5 nmol/hr/mL, or leukocyte αGAL activity of \< 4 nmol/hr/mg), or a known mutation compatible with Fabry disease.
- Patients with either:
- eGFRMDRD ≥ 20 and ≤ 60 ml/min/1.73 m2, and documented baseline urine protein/creatinine ratio \> 0.5, based on the last value obtained before initiating ACEI/ARB therapy or obtained at screening before the first Evaluation Visit of the FAACET Study; or
- eGFRMDRD ≤ 125 ml/min/1.73 m2 and \> 60 ml/min/1.73 m2 with documented baseline urine protein/creatinine ratio \> 1, based on the last value obtained before initiating ACEI/ARB therapy or obtained at screening before the first Evaluation Visit of the FAACET Study.
Exclusion
- The patient has undergone kidney transplantation or is currently on dialysis, or is planning on receiving a kidney transplant during the first year of the study.
- The patient has diabetic nephropathy or the presence of another, confounding kidney disease unless there is kidney biopsy confirmation that the patient does not have diabetic nephropathy or another, confounding kidney disease.
- The patient has a clinically significant organic disease, or other condition that in the opinion of the investigator would preclude participation in the full extent of the trial.
- The patient is unwilling to comply with the requirements of the protocol, including continuing on Fabrazyme® at 1 mg/kg body weight every two weeks.
- Patients who have documented allergies to ACE inhibitors and to ARBs are not eligible to participate in the FAACET Study.
- The patient is pregnant or intends to become pregnant during the course of the study.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00446862
Start Date
March 1 2007
End Date
December 1 2012
Last Update
November 19 2013
Active Locations (6)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
2
Emory University
Atlanta, Georgia, United States, 30322
3
Feinberg School of Medicine, Northwestern University
Chicago, Illinois, United States, 60614
4
University of Iowa
Iowa City, Iowa, United States, 52242