Status:
TERMINATED
ACTHar in the Treatment of Lupus Nephritis
Lead Sponsor:
Columbia University
Conditions:
Lupus Nephritis
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief 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 exp...
Detailed 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 o...
Eligibility Criteria
Inclusion
- Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR)/SLICC criteria
- Age ≥ 16 years
- Active lupus nephritis defined by:
- a. 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02226341
Start Date
October 1 2014
End Date
January 3 2024
Last Update
March 7 2025
Active Locations (1)
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1
Columbia University - Herbert Irving Pavilion
New York, New York, United States, 10032