CompletedPhase 2

Podocyte Retinoids

United States12 participantsStarted 2004-11-26

Plain-language 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.

Who can participate

Age range16 Years

SexALL

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Inclusion criteria

✓-An adequate renal biopsy, defined as having minimum 10 glomeruli for light microscopy and minimum 3 glomeruli for electron microscopy, unless the podocyte disease is diagnostic on fewer glomeruli. Patients who have non-diagnostic or technically inadequate biopsies will be offered the opportunity to undergo a research biopsy to determine eligibility. For some patients who have had a non-diagnostic or technically inadequate biopsy, a repeat renal biopsy may be clinically indicated in an effort to diagnose and treat a potentially serious kidney disease.

What they're measuring

Change in Proteinuria at Week 24 From Baseline

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT00098020

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2016-06-27

Results submitted2017-06-08

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