Adrenocorticotropic Hormone in Membranous Nephropathy

Icahn School of Medicine at Mount Sinai5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Membranous Nephropathy

Interventions

ACTHarDRUG

for 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 70 years * Free of immunosuppression for at least 3 months * Capability of understanding the purpose of the study * Written informed consent Exclusion Criteria: * Epidermal growth factor receptor (eGFR) \< 30ml/min/1.73m2 * Kidney Transplant * Secondary MN (defined on the basis of clinical criteria) * Type 1 or Type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion) * History of previous use of Acthar for treatment of nephrotic syndrome * Prior sensitivity to Acthar or other porcine protein products * Contraindication to Acthar per Prescribing Information * Planned treatment with live or live attenuated vaccines once enrolled in the study * More than three previous treatment regiments * Participation to other clinical trials over the previous 12 months * History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas * Pregnancy * Lactation * Current substance abuse * Any clinically relevant condition that might affect study participation and/or study results

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

Change in Proteinuria

Change in proteinuria at baseline versus after 12 months of treatment as measured by urine protein/creatinine ratio

Time frame: baseline and 12 months

Secondary Outcomes

Number of Participants With Complete or Partial Remission

Complete (proteinuria reduction \<500mg/24h) or partial (urinary protein excretion (P/C) \<3.0 g/g (with at least 50% reduction versus baseline) in at least two consecutive visits) remission.

Time frame: 12 months

Change in Serum Albumin

Change in serum albumin from baseline

Time frame: baseline 6 months, 12 months

Estimated Glomerular Filtration Rate (GFR)

GFR measures kidney function.

Time frame: baseline and 12 months

Number of Anti-PLA2R Memory B Cells

Number of anti-PLA2R memory B cells

Time frame: 12 months

Anti-PLA2R Antibodies Levels

blood levels Number of anti-PLA2R memory B cells

Time frame: 12 months

Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio

blood levels - one single cell subset identified by different markers

Time frame: baseline and 12 months

Data from ClinicalTrials.gov

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