NCT03025828

Adrenocorticotropic Hormone in Membranous Nephropathy

Changes in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous Nephropathy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH, Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous nephropathy. Acthar is a hormone that stimulates steroid production from small glands above the kidneys. It has direct protective effects on the kidney and is currently approved by the FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of action are not entirely understood and will be studied in the present trial.

Detailed description

Patients with membranous nephropathy and nephrotic syndrome will be treated with ACTH for 6 months. Proteinuria remission at 12 months will be the primary endpoint. Different biomarkers including anti-PLA2R autoantibodies, circulating regulatory T cells, and autoreactive memory B cells will be serially measured to identify predictors of response to therapy.

Conditions

• Membranous Nephropathy

Interventions

Type	Name	Description
DRUG	ACTHar	for 6 months

Timeline

• Start date: 2018-03-19
• Primary completion: 2020-12-16
• Completion: 2020-12-16
• First posted: 2017-01-20
• Last updated: 2022-08-15
• Results posted: 2022-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study