Blood test may help some ANCA patients skip unnecessary drugs
NCT ID NCT03906227
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a specific type of immune cell (CD5+ regulatory B cells) can predict relapse risk in people with ANCA vasculitis, a rare autoimmune disease that damages blood vessels. Researchers aimed to see if patients with normal levels of these cells after initial treatment could safely stop maintenance therapy. The study was terminated early with only 9 participants, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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9 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients 18-85 years old. * ANCA Glomerulonephritis (GN) or vasculitis per Chapel Hill Consensus Criteria, with documented current or previously positive Myeloperoxidase (MPO)- or Proteinase 3 (PR3)-ANCA by ELISA test. Patients with biopsy-proven, pauci-immune crescentic glomerulonephritis are eligible if they have a positive ANCA test by immunofluorescent microscopy (IIFM). * Patients must be in complete remission for at least 1 month and after AT LEAST 3 MONTHS of induction of therapy with corticosteroids and rituximab (either 1000 mg IV x 2 or 375 mg/m2 IV x 4) OR corticosteroids and cyclophosphamide (monthly IV or daily oral doses). They must be on no more than 5 mg daily of oral prednisone or equivalent. Complete remission is defined as a Birmingham Vasculitis Activity Score (BVAS) score = 0. * Patients may be ANCA negative or positive at randomization. * B cells are not depleted anymore: B cell recovery reaches 1% CD19+ B cells (enough to allow determination of CD5+ B cells with confidence). Exclusion Criteria: * Patients who have had ≥ 2 relapses (defined as recurrence of any signs or symptoms attributable to active vasculitis) previously as patients with multiple prior relapses may be at higher risk of future relapse and require maintenance therapy * Patients with persistent low-grade disease activity ("grumbling" disease defined as BVAS \> 0 and ≤ 3) * Patients with active systemic infections or deep space infections within the 3 months prior to screening. * Patients participating in another clinical trial mandating maintenance therapy * Patients with drug-induced ANCA vasculitis (e.g. levamisole-adulterated cocaine) * Active tuberculosis, human immunodeficiency virus (HIV), hepatitis C virus or hepatitis B virus infections * For women of child-bearing potential, pregnancy, breastfeeding, unwillingness or inability to comply with effective contraception * Inability to come to scheduled visits
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7155, United States
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Other studies related to the condition(s) this trial covers.
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