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Corticosteroid
ACTHar Gel for Lupus Nephritis (ACTHar Trial)
Phase 4
Recruiting
Led By Anca D Askanase, MD, MPH
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
ACTHar Trial Summary
This trial is testing a gel form of ACTH to see if it is safe and effective in treating Lupus Nephritis, a kidney inflammation caused by Lupus.
Who is the study for?
This trial is for individuals aged 16 or older with Systemic Lupus Erythematosus (SLE) who have active lupus nephritis, as confirmed by a kidney biopsy. Participants must not have severe anemia, infections that could increase risk, HIV/hepatitis B/C, end-stage renal disease, recent cancer (except certain skin cancers), be pregnant/lactating, or unwilling to use birth control.Check my eligibility
What is being tested?
The study is testing the effectiveness and safety of two dosing regimens of ACTHar gel in treating proliferative Lupus Nephritis. It aims to see if these treatments can reduce inflammation in the kidneys caused by SLE without causing significant harm.See study design
What are the potential side effects?
While specific side effects are not listed here, ACTHar gel may cause potential immune system changes due to its action on inflammation. Side effects might include hormonal imbalances, mood swings, increased blood pressure and blood sugar levels.
ACTHar Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 16 years old or older.
Select...
I have active lupus affecting my kidneys with specific biopsy results and high protein in my urine.
Select...
I have been diagnosed with Lupus according to ACR/SLICC criteria.
ACTHar Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of patients with a complete response (CR)
Secondary outcome measures
Mean cortisol levels
Mean urinary lymphocytes
Percent of patients with extra-renal flares
+3 moreACTHar Trial Design
2Treatment groups
Active Control
Group I: CellCept daily & ACTHar gel biwActive Control2 Interventions
Patients will be treated with CellCept 3 grams daily and ACTHar gel 80 U biw for 3 months. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months.
Group II: CellCept daily & ACTHar gel qodActive Control2 Interventions
Patients will be treated with CellCept 3 grams daily for 3 months, and ACTHar gel 80 U qod for the first month and ACTHar gel 80 U biw for the following 2 months. After 3 months, patients with complete response will stop ACTHar gel but continue CellCept 3 grams daily for another 3 months whereas patients with partial response will continue CellCept 3 grams daily and be offered the option to continue ACTHar 80 U biw for another 3 months. After 6 months, all patients will continue CellCept at a dose of 2 grams daily for another 18 months.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,436 Previous Clinical Trials
2,448,260 Total Patients Enrolled
1 Trials studying Lupus Nephritis
46 Patients Enrolled for Lupus Nephritis
Anca D Askanase, MD, MPHPrincipal InvestigatorColumbia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your neutrophil count is less than 1,000 per milliliter of blood.I am 16 years old or older.Your hemoglobin level is less than 8 mg/dL.Your platelet count is less than 50,000/mm3.You have HIV, hepatitis B, or hepatitis C.My kidney function is severely reduced.I have had cancer before, but it was either in situ, basal cell, or squamous cell carcinoma and has been treated.My condition did not improve with MMF treatment.I have used rituximab in the last year.I do not have severe or worsening kidney, liver, blood, stomach, lung, heart, or brain diseases that could make participating risky, except for conditions related to my lupus.I have active lupus affecting my kidneys with specific biopsy results and high protein in my urine.I have been diagnosed with Lupus according to ACR/SLICC criteria.You are currently using drugs or alcohol excessively.You have tested positive for tuberculosis using the PPD and Quantiferon TB Gold tests.Your liver function tests show that your liver may not be working properly.You have signs of previous tuberculosis in your chest X-ray.
Research Study Groups:
This trial has the following groups:- Group 1: CellCept daily & ACTHar gel biw
- Group 2: CellCept daily & ACTHar gel qod
Awards:
This trial has 5 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies remaining in this medical investigation?
"Affirmative. Clinicaltrials.gov hosts the data which demonstrates that this clinical trial, first posted on October 1st 2014, is still in search of participants. The study requires 20 patients to be recruited from a single location."
Answered by AI
Has the FDA granted authorization for daily CellCept and ACTHar gel usage?
"Our team at Power ranks the safety of CellCept daily & ACTHar gel biw as a 3, due to this being an approved Phase 4 trial."
Answered by AI
To what medical conditions are CellCept daily and ACTHar gel frequently prescribed?
"CellCept daily & ACTHar gel biw is typically prescribed for acute coryza, but has also been found to be effective in treating a variety of other medical issues such as organ rejection, kidney transplantation and various types of arthritis. Additionally, this medication can prove beneficial in cases of juvenile and optic neuritis."
Answered by AI
Could you please provide an overview of any other research conducted on the use of CellCept daily and ACTHar gel biw?
"Presently, there are 137 ongoing studies related to CellCept daily & ACTHar gel biw with 17 trials at Phase 3. Majority of these experiments take place in Philadelphia, Pennsylvania though 944 clinical trial sites feature this medication."
Answered by AI
What is the enrollment size for this research project?
"Indeed, the details on clinicaltrials.gov allude to this trial being open for recruitment right now. This investigation was initially posted October 1st 2014 and last modified March 17th 2016; 20 individuals are required at one medical centre."
Answered by AI
Who else is applying?
What site did they apply to?
Columbia University - Herbert Irving Pavilion
What portion of applicants met pre-screening criteria?
Did not meet criteria
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