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Trial record 1 of 1 for:    NCT01926054
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ACTHAR GEL in Patients With Membranous (Class V) Lupus Nephritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01926054
Recruitment Status : Withdrawn (Lack of recruitment)
First Posted : August 20, 2013
Last Update Posted : May 11, 2018
Information provided by (Responsible Party):
Brad Rovin, MD, Ohio State University

Brief Summary:

This is an open-label, randomized, multi-center, Phase IV study of Acthar Gel in patients with biopsy-proven membranous (Class V) lupus nephritis (LN) aimed at providing proof-of-concept data that Acthar is a safe and effective therapy for membranous LN. Class V LN is a secondary form of membranous nephropathy, and occurs in 8-20% of patients with LN.

Two different doses of Acthar Gel will be tested. The active intervention phase of this study will take place over 6 months, and follow-up will occur over the following 6 months. Efficacy and safety of the use of Acthar Gel for treatment of membranous LN will be assessed and analyzed throughout the course of the study by laboratory testing, physical exams, and other evaluation tools. Subjects will be closely monitored for adverse effects associated with the use of Acthar gel and if necessary study drug dosing will be reduced. The anticipated benefits to subjects are a complete renal response rate of 40% at 6 months showing superiority over the published complete remission rates of the currently used immunosuppressive therapies, and no unexpected toxicity signals.

Pure Class V LN affects a significant number of systemic lupus erythematosus (SLE) patients and although it is less aggressive than proliferative forms of LN it still causes important renal and non-renal morbidity and mortality over time, especially in patients who remain nephrotic. The therapy of Class V LN is not clear, and currently used therapies are highly toxic because of immunosuppression, risk of infertility, and risk of future malignancy. Additionally, these therapies are only modestly effective in inducing remissions of Class V LN. There is thus an unmet need for a more effective and less toxic treatment for Class V LN.

Condition or disease Intervention/treatment Phase
SLE Glomerulonephritis Syndrome, WHO Class V Drug: Acthar gel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Randomized Phase IV Study of the Safety and Efficacy of ACTHAR GEL in Patients With Membranous (Class V) Lupus Nephritis
Study Start Date : July 2013
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Acthar Gel 80 IU SC BIW
80 IU administered subcutaneously BIW for 6 months
Drug: Acthar gel
Active Comparator: Acthar Gel 80 IU SC TIW
80 IU administered subcutaneously TIW for 6 months
Drug: Acthar gel

Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Baseline and Month 12 ]
    Measuring adverse events and serious adverse events taking Acthar Gel in Class V lupus nephritis

  2. Change in laboratory data [ Time Frame: Baseline and Month 12 ]
    changes in laboratory parameters, and metabolic side effects such as hyperglycemia, hypokalemia, and hyperlipidemia

  3. Renal Response to Acthar Gel [ Time Frame: Baseline and Month 6 ]
    Change in Proteinuria and serum creatinine

Secondary Outcome Measures :
  1. Change in remission [ Time Frame: Month 6 and Month 12 ]
    To determine the duration of complete and partial remission after study drug is stopped

  2. Change baseline SLE laboratory [ Time Frame: Baseline and month 6 ]
    To determine the effect of Acthar Gel on baseline levels of anti-double stranded DNA (dsDNA) antibodies and complement components C3 and C4

  3. Change in extra-renal systemic lupus erythematosus disease activity index [ Time Frame: Baseline and Month 6 ]
    To determine the effect of Acthar Gel on the patients global assessment score, the physicians global assessments score and xSLEDAI

Other Outcome Measures:
  1. reduction of urine protein to creatinine ratio [ Time Frame: week 8 and month 6 ]
    To determine if a reduction of the urine protein-to-creatinine ratio (uPCR) of an intended 24-hour of ≥25% at 8 weeks predicts complete or partial response at 6 months

  2. change urine monocyte chemotactic protein-1 and urine vascular endothelial growth factor [ Time Frame: Baseline and 6 month ]
    To determine change from baseline of urine monocyte chemotactic protein-1 (uMCP1) and urine vascular endothelial growth factor (uVEGF) at 3 and 6 months

  3. percent of patients who have renal and non renal flares [ Time Frame: baseline and month 12 ]
    To determine the % of patients who have renal flares during treatment and during follow-up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients ≥ 18 years of age who have pure Class V LN or Class V+II LN diagnosed by a kidney biopsy within 4 months of screening. If a patient has segmental glomerular scarring indicative of previous Class III or IV lesions, but no evidence of current Class III or IV activity, and only the Class V component is active, they can be enrolled, despite having a mandatory ISN/RPA classification of Class V + III or IV
  • Proteinuria ≥ 3 g/d despite adequate blood pressure control defined as systolic blood pressure ≤ 130 mm Hg 75% of the time, per the clinical judgment of the site investigator.
  • Serum creatinine < 2 mg/dl or eGFR > 30 ml/minute

Exclusion Criteria:

  • Patients < 18 years of age

    • Pregnancy or planning to become pregnant anytime throughout their participation in the trial, up until 30 days after last dose of study drug.
    • Kidney biopsy with active Class III or IV LN
    • More than 50% interstitial fibrosis and/or glomerulosclerosis on kidney biopsy
    • Patients with hepatitis B, C, HIV, TB or other active and chronic infections at the time of screening
    • Patients with liver disease and transaminases greater than 2.5 times the upper limit of normal of the laboratory, patients with diabetes mellitus type I or II, patients with refractory hypokalemia, patients with Cushing's Disease or Syndrome
    • Patients who have been treated with cyclophosphamide, cyclosporine A, tacrolimus, B-cell depleting therapies, or experimental therapies including biologics within 6 months of screening
    • Patients with active neuropsychiatric lupus, lupus pneumonitis, lupus vasculitis at screening
    • Patients with high or very high extra-renal lupus activity defined as an xSLEDAI score greater than 10 at the time of screening
    • Patients who have received high-dose intravenous methylprednisolone (1 g cumulative) within 3 months of screening
    • Patients currently receiving, or who have received MMF or AZA in the 3 months preceding enrollment for extra-renal SLE.
    • Patients who have received methotrexate or who are receiving methotrexate and it can be discontinued will be eligible; if methotrexate cannot be stopped safely, the patient will not be eligible.
    • Patients currently receiving more than 20 mg/d prednisone that cannot be safely reduced to 20mg/d or less beginning at least one month before enrollment on day 0
    • Patients who are not on a stable dose of Anti-Malarials and/or Anti-hypertensives at least one month preceding baseline visit and during the study. (Refer to allowed medication section)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01926054

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United States, Ohio
The Ohio State University Wexner Medical Center, Nephrology Clinical Trials Unit
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
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Principal Investigator: Brad H Rovin, MD The Ohio State University Wexner Medical Center, Division of Nephrology
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Responsible Party: Brad Rovin, MD, Principle Investigator, Ohio State University Identifier: NCT01926054    
Other Study ID Numbers: 2013H0121
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Lupus Nephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases