Adrenocorticotropic Hormone in Membranous Nephropathy

NCT ID: NCT03025828

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-19
• Study Completion Date: 2020-12-16

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.

Conditions

Membranous Nephropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acthar

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

Group Type: EXPERIMENTAL

ACTHar

Intervention Type: DRUG

for 6 months

Interventions

ACTHar

for 6 months

Intervention Type: DRUG

Other Intervention Names

ACTH; Acthar Injectable Product; Repository corticotropin injection; RCI; Acthar® Gel

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Paolo Cravedi

Assistant Professor, Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Cravedi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 16-2402

Identifier Type: -

Identifier Source: org_study_id