drugset / Trial / NCT01839526

A Study of Renal Function in Treatment-naïve, Young Male Patients With Fabry Disease

NCT01839526

Phase 1 Terminated 39 enrolled Genzyme, a Sanofi Company
NaSingle-groupOpen-labelBasic science

Summary

No investigational drug will be administered in this study for the treatment of Fabry disease. This will be a multicenter, multinational, non-treatment, cross-sectional study of young male patients with Fabry disease who have not yet initiated interventional treatment for this disease. The study will consist of a screening visit(s), a clinical investigation visit(s), and a follow-up phone contact. The objectives of the study are: * To document renal function and other Fabry disease manifestations across age in treatment-naïve, young male patients with Fabry disease. * To provide a reference group for comparison with interventional clinical trials of Fabry disease. The duration of each patient's participation in the study, inclusive of the screening visit and follow-up phone contact, will be approximately 12 weeks.

Timeline

Start
2013-05
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Iohexol Diagnostic / imaging agent

Indications