SLE Glomerulonephritis Syndrome, WHO Class VPhase 4NCT01926054
ACTHAR GEL in Patients With Membranous (Class V) Lupus Nephritis
A Phase 4 study testing Acthar gel in people with SLE Glomerulonephritis Syndrome, WHO Class V, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SLE Glomerulonephritis Syndrome, WHO Class V
- What is being tested?
- Acthar gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 28 Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center, Nephrology Clinical Trials Unit
Columbus, Ohio, 43210
About this study
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
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.
- Being tested
- Acthar gel
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acthar gelDrug
| Study group | Role | What they receive |
|---|---|---|
| Acthar Gel 80 IU SC BIW | Active comparator | 80 IU administered subcutaneously BIW for 6 months Receives: Drug: Acthar gel |
| Acthar Gel 80 IU SC TIW | Active comparator | 80 IU administered subcutaneously TIW for 6 months Receives: Drug: Acthar gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measuring adverse events and serious adverse events taking Acthar Gel in Class V lupus nephritis
Measured: Baseline and Month 12
Change in laboratory data
changes in laboratory parameters, and metabolic side effects such as hyperglycemia, hypokalemia, and hyperlipidemia
Measured: Baseline and Month 12
Renal Response to Acthar Gel
Change in Proteinuria and serum creatinine
Measured: Baseline and Month 6
Secondary outcomes (3)
Change in remission
To determine the duration of complete and partial remission after study drug is stopped
Measured: Month 6 and Month 12
Change baseline SLE laboratory
To determine the effect of Acthar Gel on baseline levels of anti-double stranded DNA (dsDNA) antibodies and complement components C3 and C4
Measured: Baseline and month 6
Change in extra-renal systemic lupus erythematosus disease activity index
To determine the effect of Acthar Gel on the patients global assessment score, the physicians global assessments score and xSLEDAI
Measured: Baseline and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2018
- Study completion28 Feb 2018
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLE Glomerulonephritis Syndrome, WHO Class VStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Principal investigator, Brad Rovin, MD, Ohio State University
- Investigators
- Brad H Rovin, MD, Principal investigator, The Ohio State University Wexner Medical Center, Division of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926054
- Sponsor's protocol ID
- 2013H0121
- Status last verified
- May 2018
- First submitted
- 15 Jul 2013
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01926054
- Acronym / sponsor ID
- 2013H0121
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Jul 2013
- Primary completion
- Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acthar Gel 80 IU SC BIW | Active comparator | Drug: Acthar gel80 IU administered subcutaneously BIW for 6 months |
| Acthar Gel 80 IU SC TIW | Active comparator | Drug: Acthar gel80 IU administered subcutaneously TIW for 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- Patients < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acthar gel | Drug | Acthar Gel 80 IU SC BIW, Acthar Gel 80 IU SC TIW |
Primary outcome
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
Change in laboratory data
Time frame: Baseline and Month 12
changes in laboratory parameters, and metabolic side effects such as hyperglycemia, hypokalemia, and hyperlipidemia
Renal Response to Acthar Gel
Time frame: Baseline and Month 6
Change in Proteinuria and serum creatinine
3 secondary outcomes
Change in remission
Time frame: Month 6 and Month 12
Change baseline SLE laboratory
Time frame: Baseline and month 6
Change in extra-renal systemic lupus erythematosus disease activity index
Time frame: Baseline and Month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad H Rovin, MD principal investigator
The Ohio State University Wexner Medical Center, Division of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acthar gel in people with SLE Glomerulonephritis Syndrome, WHO Class V, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Baseline and Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.