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Mucolytic Agent

N-acetylcysteine for Lupus (NAC Trial)

Phase 2
Recruiting
Led By Andras Perl, M.D., Ph.D.
Research Sponsored by State University of New York - Upstate Medical University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
SLE with ≥ 4 of eleven diagnostic criteria approved by the American College of Rheumatology
Age > 18 years old
Must not have
Patients receiving mTOR inhibitors (rapamycin/sirolimus, everolimus)
Acute flare of SLE threatening vital organs and requiring intravenous
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months

Summary

This trial is a phase II study to test the safety and efficacy of N-acetyl cysteine (NAC) in treating systemic lupus erythematosus (SLE). SLE is a chronic inflammatory disease which often has debilitating and potentially life-threatening consequences. The cause of SLE is unknown and current therapies lack specificity and carry significant side-effects. This study will have two groups of 105 subjects each, with one group continuing the tolerated dosage of NAC and the other group switched to placebo capsules. The study will last 13 months with seven study visits per subject. Each subject will donate approximately 100 ml of blood

Who is the study for?
Adults over 18 with active Systemic Lupus Erythematosus (SLE) can join this trial. They should have a certain level of disease activity but not in the kidneys or central nervous system, and be on stable medication doses for SLE. People who are pregnant, breastfeeding, recently in other trials, or have serious health issues like heart failure cannot participate.
What is being tested?
The study tests N-acetylcysteine (NAC), an antioxidant thought to help with SLE symptoms by adjusting glutathione levels. Participants will first find a tolerable dose over three months before being randomly assigned to continue NAC or switch to placebo for another ten months.
What are the potential side effects?
Potential side effects of N-acetylcysteine may include nausea, vomiting, rash, and headache. However, since it's an antioxidant supplement commonly used for other conditions as well, severe side effects are generally rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with lupus and meet at least 4 of the criteria set by the American College of Rheumatology.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking mTOR inhibitors for my condition.
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I have a severe lupus flare affecting vital organs, needing IV treatment.
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I have a serious health condition like diabetes, heart failure, lung disease, or kidney problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement of disease activity
Therapeutic benefit
Tolerance and safety
Secondary study objectives
Immunobiological outcomes measurable improved lymphocyte function

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: NACActive Control1 Intervention
2.4 g - 4.8 g of NAC daily starting after 3 month open label titration period.
Group II: PlaceboPlacebo Group1 Intervention
2.4 g - 4.8 g of placebo per day after 3 month open label titration period.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterOTHER
512 Previous Clinical Trials
163,074 Total Patients Enrolled
Yale UniversityOTHER
1,924 Previous Clinical Trials
3,031,368 Total Patients Enrolled
University of RochesterOTHER
869 Previous Clinical Trials
549,472 Total Patients Enrolled

Media Library

N-acetylcysteine (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT00775476 — Phase 2
Lupus Research Study Groups: NAC, Placebo
Lupus Clinical Trial 2023: N-acetylcysteine Highlights & Side Effects. Trial Name: NCT00775476 — Phase 2
N-acetylcysteine (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00775476 — Phase 2
~140 spots leftby Mar 2027
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