At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of podocyte disease (MCD, FSGS primary/secondary/adaptive, or collapsing glomerulopathy including HIV-associated) with adequate renal biopsy (≥10 glomeruli for light microscopy, ≥3 for electron microscopy)
- ✓Age ≥16 years
- ✓Prior treatment with ≥2 immunosuppressive agents (glucocorticoids, cyclosporine, tacrolimus, cyclophosphamide, chlorambucil, mycophenolate mofetil) for ≥8 weeks each; exemptions for contraindications or intolerance
- ✓Off immunosuppression for ≥4 weeks before starting retinoids
- ✕Pregnancy or breastfeeding, or unwillingness to use ≥2 contraceptive methods (≥1 primary)
- ✕Abnormal liver function tests (AST, ALT, total bilirubin, or protime); exception if cause is hepatotoxic drug with levels <2× ULN that normalize upon discontinuation
- ✕Hypertriglyceridemia >500 mg/dL despite statin/fibrate therapy
- ✕Concurrent immunosuppression required for other medical conditions
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Retinoids for Podocyte Disease
In Brief
A Phase 2 clinical trial evaluating Isotretinoin for Collapsing Glomerulopathy and Glomerulosclerosis, Focal Segmental. Completed, enrolled 12 participants across 1 site.
Detailed Summary
This is a pilot study of retinoids for patients with unsatisfactory response to conventional treatment of nephrotic syndrome due to focal segmental glomerulosclerosis or minimal change disease, two renal disorders associated with putatively pathogenic malfunctioning of glomerular podocytes. The hypothesis that retinoids may have reparative effects on these cells is based on previous research showing that retinoids promote the differentiation or redifferentiation of aberrant epithelial cells. Results obtained by 6 months of treatment with retinoids (that have been approved for non-renal indications) will be used as preliminary information upon which to base further testing of these agents in formal clinical trials in refractory cases of these nephrotic syndromes.