Safety and Efficacy of Combination Acthar Gel and Tacrolimus in the Treatment of Steroid Resistant Nephrotic Syndrome

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Conditions studied: Nephrotic Syndrome

In brief

The management of steroid-resistant nephrotic syndrome (SRNS) remains a persistent problem for investigators in part because of the wide array of pathogenic cccccccccc mechanisms that contribute to these disorders as well as the lack ofs. While glucocorticoids remain the primary therapy for many forms of protein uric glomerularxxxxxxxxx diseases, prolonged use is associated with significant morbidities including steroid induced diabetes, metabolic bone disease, and excessive weight gain.

Key facts

Study ID

NCT03042637

Run by

Southeast Renal Research Institute

Starts

2012-01-01

Expected to finish

2021-12-01

Last updated by the study team

2021-02-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• refractory nephrotic syndrome secondary, defined as subjects having a urine protein/Cr ratio over 3.0 while actively receiving ACE inhibitors and hyperglycemic therapy (i.e., insulin or oral hyperglycemic agents).
• Type I or Type II diabetes
• receiving combination therapy with an ACE inhibitor and a second protein lowering agent (e.g., ARB, non dihydropyridine CCB, or spironolactone).

You may not qualify if…

• known primary or secondary membranous glomerulonephritis (GN)
• primary or secondary focal segmental glomerulosclerosis
• other nondiabetic forms of glomerulopathy

Where it is running

• Nephronet — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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