Tailoring Maintenance Therapy to Cluster of Differentiation 5 Positive (CD5+) Regulatory B Cell Recovery in ANCA Vasculitis
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ClinicalTrials.gov Identifier: NCT03906227 |
Recruitment Status :
Recruiting
First Posted : April 8, 2019
Last Update Posted : January 25, 2023
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Condition or disease | Intervention/treatment | Phase |
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ANCA Associated Vasculitis | Device: ENUMERATION OF CD5+ B Cells | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Subjects with normalized CD5+ B cells are thought to be at lower risk and relapse, and therefore may not need maintenance immunosuppression. The subjects in that group will be randomized to either maintenance immunosuppression vs close clinical observation without maintenance immunosuppression. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Tailoring Maintenance Therapy to CD5+ Regulatory B Cell Recovery in ANCA Vasculitis |
Actual Study Start Date : | June 28, 2019 |
Estimated Primary Completion Date : | December 2027 |
Estimated Study Completion Date : | June 2030 |
Arm | Intervention/treatment |
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Active Comparator: low CD5+ /on maintenance
Subjects in remission with Cluster of Differentiation (CD)19+CD5+ lower than 43% will continue on maintenance immunosuppression (Maintenance Therapy Group)- no randomization.
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Device: ENUMERATION OF CD5+ B Cells
A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm. |
Active Comparator: high CD5/ on maintenance
Subjects in remission with CD19+CD5+ 43% or greater, randomized to continue on maintenance immunosuppression (Maintenance Therapy Group)
|
Device: ENUMERATION OF CD5+ B Cells
A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm. |
Experimental: high CD5 / NO maintenance
Subjects in remission with CD19+CD5+ 43% or greater , randomized to NO maintenance immunosuppression (NO Maintenance Therapy Group)
|
Device: ENUMERATION OF CD5+ B Cells
A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm. |
- Time to First Relapse [ Time Frame: from complete remission to end of study, approximately 2 years ]The primary outcome measure is time to first relapse defined as recurrence of any signs or symptoms attributable to active vasculitis after a period of complete remission, with at least 2 minor or 1 major item on the BVAS score (BVAS≥2). Per protocol, complete remission is defined as a BVAS score = 0. Birmingham Vasculitis Activity Score for Wegener's Granulomatosis(BVAS, range 0-64). The total score is composed of 34 predefined items, units on a scale, grouped into 9 organ systems. Each item carries a weight from 1-3, depending on disease severity. A score of 0 indicates no disease activity; a higher score indicates worsening disease.
- Severity of Relapse [ Time Frame: from complete remission to end of study, approximately 2 years ]severity (as determined by BVAS score) of relapse in each group
- Frequency of Relapse [ Time Frame: from complete remission to end of study, approximately 2 years ]frequency, as determined by number of relapse in each group
- Time to Positive ANCA [ Time Frame: from first negative ANCA test since start of study , if applicable- to end of study, maximum two years, as applicable ]for patients who had a negative ANCA test, time to positive ANCA
- Frequency of Infections [ Time Frame: from remission to end of study, approximately 2 years ]number of infections
- Number of Infections, categorized by severity [ Time Frame: from remission to end of study, approximately 2 years ]number of mild/moderate/serious infections
- Time to IL-10 secreting B regulatory cells > 45% or CD5+ B cells > 43% of total B cells [ Time Frame: from enrollment to end of study, approximately 2.5 to 3 years ]time to IL-10 secreting B regulatory cells > 45% or CD5+ B cells > 43% of total B cells

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03906227
Contact: Anne Froment | (919) 445-2622 | anne_froment@med.unc.edu | |
Contact: Caroline Poulton | (919) 445-2636 | Caroline_jennette@med.unc.edu |
United States, North Carolina | |
University of North Carolina at Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7155 | |
Contact: Vimal K Derebail, MD 919-966-2561 vimal_derebail@med.unc.edu | |
Contact: Anne Froment 919-445-2622 anne_froment@med.unc.edu | |
Principal Investigator: Vimal K Derebail, MD |
Principal Investigator: | Vimal Derebail, MD | University of North Carolina, Chapel Hill |
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT03906227 |
Other Study ID Numbers: |
18-2015 5P01DK058335-18 ( U.S. NIH Grant/Contract ) |
First Posted: | April 8, 2019 Key Record Dates |
Last Update Posted: | January 25, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
Time Frame: | 9 to 36 months following publication |
Access Criteria: | approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and data use/sharing agreement with UNC. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Vascular Diseases Cardiovascular Diseases |
Systemic Vasculitis Autoimmune Diseases Immune System Diseases |