Retinoids in ANCA Small Vessel Vasculitis: Silencing Autoantigens
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|ClinicalTrials.gov Identifier: NCT01275274|
Recruitment Status : Withdrawn (no subject enrolled in nearly 2 years)
First Posted : January 12, 2011
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis||Drug: Retinoic acid Drug: Standard of care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Retinoids in ANCA Small Vessel Vasculitis: Silencing Autoantigens|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Active Comparator: Standard of care
maintenance therapy with azathioprine or mycophenolate mofetil with or without small dose prednisone.
Drug: Standard of care
maintenance therapy with azathioprine or mycophenolate mofetil with or without small dose prednisone. Dose, frequency and duration depend on disease activity (partial or complete remission).
Experimental: Retinoic acid
Tretinoin in addition to standard of care
Drug: Retinoic acid
Patients will be started at half the recommended dose of retinoic acid for the treatment of acute promyelocytic leukemia (APL), i.e. 22.5mg/m2/day orally in two divided doses, to minimize the risk of adverse events. If there is no decrease in PR3/MPO gene expression to a fold change of < 2 by quantitative polymerase chain reaction(QT-PCR) technique for PR3 at the end of 4 weeks, the dose will be increased to 45 mg/m2/day in two divided doses for an additional 8 weeks. If the patient shows a decrease in PR3/MPO gene expression to < 2 at 4 weeks, the patient will remain on the same dose for the remainder of 12 weeks. All patients will be followed for a total of 12 months for safety evaluations and to assess changes in disease activity and the incidence of disease relapse.
Other Name: Tretinoin
- change in leukocyte Myeloperoxidase (MPO) and Proteinase 3 (PR3) message [ Time Frame: week 12 ]normalization of PR3 and MPO message at the end of treatment.
- Birmingham Vasculitis Activity Score (BVAS) [ Time Frame: 52 weeks ](1) Change in BVAS at the end of treatment (week 12) and at week 52, compared to baseline (day 1); (2) Change in Treg and Th17 cells at weeks 12 and 52, compared to baseline (day 1); and (3) the frequency of relapse during the follow up period.
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): NCT01275274
|United States, North Carolina|
|UNC Kidney Center|
|Chapel Hill, North Carolina, United States, 27599-7155|
|Principal Investigator:||Patrick H Nachman, MD||UNC Kidney Center|