Multi-center, Open-label Study of the Safety and Efficacy of Control of Proteinuria with ACE Inhibitors and ARBS in Patients with Fabry Diseaswe Who Are receiving Farazyme : Tha Farazyme + Arbs + ACE inhibitors Treatments (FAACET) Study: The FAACET Study - The FAACET Study

Phase 1

• Conditions: Fabry disease with proteinuria.; MedDRA version: 9.1 Level: LLT Classification code 10018058 Term: Gene genetic abnormality; MedDRA version: 9.1 Level: LLT Classification code 10037032 Term: Proteinuria

• Registration Number: EUCTR2007-007482-21-GB
• Lead Sponsor: Salford Royal NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2009-06-10
• Study Start: 2009-08-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Must Provide written informed consent.Prior to any study proceedures being undertaken.
Already receiving Fabrazyme 1mg/kg body weight every 2 weeks.
Has confirmed Fabry Disease(documented )
eGFR >20 and <60 ml/min/1.73m2.and documented baseline urine protein/creatinine ratio >0.5 based on last value obtained before initiating ACE1/ARB therapy or obtained at screening before the first evaluation visit of FAACET Study.

eGFR<125ml/min/1.73m2 and >60ml/min/1.73m2 with documented baseline urine protein/creatinine ratio >1, based on the last value obtained before initiating ACE1/ARB therapy or obtained at screening before the first evaluation visit of the FAACET Study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The patient has undergone kidney transplant/is currently on dialysis/is planning on receiving a kidney transplnt during the first year of study.

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.

Patient has clinically significant organic disease,or other condirion 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 1mg/kg body weight every two weeks.

Patients who have documented allergies to both ACE inhibitors and ARB's are not eligible to participate in the FAACET Study.

The patient is pregnant, or intends to become pregnant during the course of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified