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:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT02585804
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects diagnosed with FSGS ≥1 month prior to informed consent
* eGFR≥45 ml/min/1.73m2
* Age 18 years or greater
* No history of diabetes
* Body Mass Index (BMI) 18.5 - 45.0 kg/ m2
* Blood pressure ≥ 100/60 at screening
* Stable therapy with either an ACEi or angiotensin II receptor blocker or direct renin inhibitor for \> 1 month
* \>30 mg/day and \<6 g/day of proteinuria unless the patient is not a candidate for immunosuppressive therapy
Exclusion Criteria:
* Leukocyte and/or nitrite positive urinalysis that is untreated;
* History of organ transplantation, cancer, liver disease;
* Bariatric surgery or other gastrointestinal surgeries that induce chronic malabsorption within the past two years;
* Current treatment with systemic corticosteroids, calcineurin inhibitors, or other immunosuppressant medications;
* Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells;
* Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practising an acceptable method of birth control;
* Participation in another therapeutic trial with an investigational drug within 30 days prior to informed consent;
* Alcohol or drug abuse within three months prior to informed consent that would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement;
* Liver disease, defined by serum levels of alanine transaminase, aspartate transaminase, or alkaline phosphatase \>3 x upper limit of normal as determined during screening;
* Cardiac, lung or peripheral vascular disease or stroke;
* Pancreas, pancreatic islet cells or renal transplant recipient;
* Medical history of cancer or treatment for cancer in the last five years prior to screening;
* History of allergy or angioedema with RAAS inhibitor exposure;
* Kidney disease due primarily to another condition aside from FSGS;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02585804
Study Brief:
Protocol Section:
NCT02585804