Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine
Public ClinicalTrials.gov record NCT00775476. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NAC) (SNAC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Systemic lupus erythematosus (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. We previously discovered the depletion of glutathione in lymphocytes of patients with SLE and associated this metabolic change with the elevation of the mitochondrial transmembrane potential. This study will titrate to tolerance during an initial 3 month open label period and then subjects will be randomized to one of 2 arms. It was determined by statistical analysis that each group must have 105 subjects. All subjects will be enrolled and evaluated for tolerance of NAC between dosages of 2.4 g/day and 4.8 g/day for 3 months. After A 3-month open-label dose-titration phase, SLE subjects will be randomized into 2 groups of 105 subjects either to continue the tolerated dosage of NAC or switched to equal number of placebo capsules. There will be up to seven study visits per SLE subject, including the screening and wash out visits. Visits 2-6 will be scheduled three months apart. The study will last 13 months with the wash-out visit. Each subject will donate approximately 100 ml of blood for biomarker studies at each visit. Healthy control subjects will donate blood at the same time. They will be matched to the SLE subjects by gender, age within 10 years, and ethnicity. Their blood will be used as reference for biomarker assays. There is a consent form required to participate in the phase II study.
Study identification
- NCT ID
- NCT00775476
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 290 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 5, 2022 (Actual)
- Primary completion
- Mar 31, 2027 (Estimated)
- Completion
- Sep 30, 2028 (Estimated)
- Last update posted
- Apr 24, 2026
2022 – 2028
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Yale Center for Clinical Investigation | New Haven | Connecticut | 06519 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30307 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| University of Columbia | New York | New York | 10032 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| VA Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| St. Luke's University Health Network | Allentown | Pennsylvania | 18102 | — |
| Penn State MS Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00775476, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 24, 2026 · Synced Sep 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00775476 live on ClinicalTrials.gov.