Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT02090608
Eligibility Criteria:
Inclusion Criteria:
* genetically proven FD
* stable dose of ERT for at least 12 months
* stable dose of ACEi or ARB titrated to maximum tolerated dosage for at least 6 months
* persistent proteinuria \>0.50 g/24 h despite the use of ERT and ACEi/ARBs in 2 consecutive samples within 12 weeks
Exclusion Criteria:
* steroid/immunosuppressive treatment or glomerular filtration rate change \>30% in the past 3 months
* PTH levels \<20 pg/mL
* serum phosphorus \>5.0 mg/dL
* serum calcium (adjusted for albumin) \>10.0 mg/dL
* active malignancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02090608
Study Brief:
Protocol Section:
NCT02090608