Adrenocorticotropic Hormone in Membranous Nephropathy

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

Sponsors

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Source Icahn School of Medicine at Mount Sinai
Brief 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.

Overall Status Recruiting
Start Date March 19, 2018
Completion Date July 2021
Primary Completion Date July 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Remission of proteinuria baseline and 12 months
Secondary Outcome
Measure Time Frame
24h Proteinuria 12 months
Estimated Glomerular Filtration Rate (GFR) 12 months
Anti-PLA2R antibodies levels 12 months
Anti-PLA2R memory B cells 12 months
CD4+CD25+CD127lowFoxP3+ T cell 12 months
Enrollment 25
Condition
Intervention

Intervention Type: Drug

Intervention Name: ACTHar

Description: for 6 months

Arm Group Label: Acthar

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Paolo Cravedi, MD, PhD Principal Investigator Icahn School of Medicine at Mount Sinai
Overall Contact

Last Name: Paolo Cravedi, MD, PhD

Phone: 212-241-3349

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Icahn School of Medicine at Mount Sinai Paolo Cravedi, MD, PhD 212-241-3349 [email protected]
Location Countries

United States

Verification Date

April 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Acthar

Type: Experimental

Description: Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov