Phase
Condition
Kidney Failure (Pediatric)
Nephropathy
Kidney Disease
Treatment
N/AClinical Study ID
Ages 2-14 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 2-14 years at onset of signs or symptoms of FSGS 2- Primary FSGS involving eithernative kidneys or primary FSGS recurring after renal transplantation. Biopsy confirmed asprimary FSGS (including all subtypes).
3-Estimated GFR ≥ 25 ml/min/1.73 m2 4- Up/c > 1.0 (g protein/g creatinine) on first am void 5- Steroid and IS resistance as defined by primary physician (patients with little or noreduction in protein excretion at 12 to 16 weeks are considered to be steroid resistant --Arelapse is return of proteinuria to ≥3.5 g/day in someone who had undergone a complete orpartial remission- IS resistance: no response to IS in 8-12 weeks) 6-At least one monthfrom last immunization received has passed 7- Ability to understand and willingness to signconsent by patient legal guardian
Exclusion
Exclusion Criteria:
- 1- Are immunodeficient or have clinically significant chronic lymphopenia 2-Have anactive infection or positive PPD test result 3-Have serologic evidence of current or pastHIV, Hepatitis B, or Hepatitis C infection 4-Have any complicating medical issues thatinterfere with study conduct or cause increased risk such as malignancies, systemicautoimmune disease, diabetes, blood disease, liver disease, etc.
5- Positive genetic mutation testing for WT1, Podocin, Nephrin
Study Design
Study Description
Connect with a study center
Royan Institute
Tehran,
Iran, Islamic Republic ofActive - Recruiting

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