ACTHar in the Treatment of Lupus Nephritis

  • STATUS
    Recruiting
  • End date
    Jul 21, 2024
  • participants needed
    20
  • sponsor
    Columbia University
Updated on 21 January 2021
cellcept
systemic lupus erythematosus
kidney biopsy
acthar
nephritis

Summary

Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the healthy cells and tissues, causing inflammation that can damage organs in the body. About 50% of SLE patients experience inflammation in the kidneys. The purpose of this study is to determine the effectiveness and safety of two dosing arms of ACTHar gel in treating proliferative Lupus Nephritis (LN). This study hypothesizes that both dosing arms of ACTHar are safe and effective in treating proliferative LN (Class III and IV).

Description

Systemic Lupus Erythematosus (SLE) is an autoimmune disease of unknown etiology that mainly affects females of childbearing age. The disease is characterized by immune activation and the development of autoantibodies.

About 50% of SLE patients experience inflammation of the kidneys. Lupus Nephritis (LN) is a major cause of morbidity and mortality in patients with SLE. Mycophenolate Mofetil (MMF), accompanied by Prednisone, is considered the current standard of care for LN. However, long-term use of Prednisone has many serious side effects.

ACTHar Gel is an FDA approved drug comprised of an active substance called adrenocorticotropic hormone (ACTH). ACTH belongs to an anti-inflammatory group called melanocortins and carries out its effects by binding to five different melanocortin receptors (MCRs). Specifically, ACTH binding to melanocortin 2 receptor subtype (MC2R) on the adrenal cortex stimulates the production of cortisol that reduces inflammation in the kidney. In addition to binding to melanocortin 1-5 receptor subtype (MC1-5R) and acting directly on kidney tissues, ACTH may bind to MCRs on various cell types, such as immune cells, and activate processes to protect the kidney.

This study will evaluate the most effective dose of ACTHar gel in proliferative LN (Class III and IV) when given with MMF, the standard of care LN therapy. The intent of this study is to determine the effectiveness and safety of ACTHar gel in an attempt to change the clinical care requirements regarding steroid use in treating LN.

Details
Condition Glomerulonephritis, Glomerulonephritis, SYSTEMIC LUPUS ERYTHEMATOSUS, SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis, Lupus Nephritis
Treatment Acthar Gel, CellCept
Clinical Study IdentifierNCT02226341
SponsorColumbia University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR)/SLICC criteria
Age 16 years
Active lupus nephritis defined by
Kidney biopsy documentation of International Society of Nephrology/Renal Pathology Society (ISN/RPS) Class III or Class IV proliferative nephritis (including Class V occurring in combination with Class III or IV) within 12 months and a urine protein/creatinine ratio >1 at time of entry to study
Ability to provide informed consent

Exclusion Criteria

Moderately severe anemia (Hgb < 8 mg/dL)
Neutropenia (< 1,000/mm3)
Thrombocytopenia (platelets < 50,000/mm3)
Positive purified protein derivative (PPD) test confirmed by positive Quantiferon TB gold
Pulmonary fibrotic changes on chest radiograph consistent with prior healed tuberculosis
Active infections that in the opinion of the investigator increase the risks to the subject
Known human immunodeficiency virus (HIV) and hepatitis B or C
End-stage renal disease (estimated GFR clearance < 20 mL/min/1.73 m2)
History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas
Pregnancy
Lactation
Unwillingness to use a medically acceptable form of birth control (including but not limited to a diaphragm, an intrauterine device, progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom)
Previous failure to respond to MMF
Use of rituximab within the past year
Use of experimental therapeutic agents within the past 60 days
Greater than or equal to 5 times the upper limit of normal of liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline phosphatase)
Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study) with the exception of diseases or conditions related to active SLE
Current substance abuse
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