Retinoids in ANCA Small Vessel Vasculitis: Silencing Autoantigens
|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Recruitment Status : Withdrawn (no subject enrolled in nearly 2 years)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.
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|