ACTHar in the Treatment of Lupus Nephritis
Stopped early · Phase 4
Conditions studied: Lupus Nephritis
In brief
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).
Key facts
- Study ID
- NCT02226341
- Run by
- Columbia University
- People needed
- 8
- Starts
- 2014-10-01
- Expected to finish
- 2024-01-03
- Last updated by the study team
- 2025-03-07
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Columbia University - Herbert Irving Pavilion — New York, New York, United States
Full record on ClinicalTrials.gov
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