CESAR (Randomized Therapeutic Study of Steroid vs. Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura)
Sponsor study identifier
interventional
200
1 country
1
Study Start
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2008
Actual (reported)Study Completion
January 2008
Actual (reported)Henoch-Schonlein purpura is a leucocytoclastic systemic vasculitis involving small vessels with the deposition of immune complexes containing IgA. It is characterized by the association of skin, joint and gastrointestinal manifestations. Even though the evolution is usually simple, some patients, especially adults, may have severe visceral involvement including heart, lung, brain and renal disease. The best treatment is currently unknown. This study will test the safety and efficacy of steroids associated or not with cyclosphosphamide to treat the acute lesions and to prevent the development of chronic lesions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 19, 2005
Actual (reported)January 2008
Actual (reported)January 2008
Actual (reported)Birmingham Vasculitis Activity Score (BVAS)
Birmingham Vasculitis Activity Score (BVAS)
during de study
Chronic lesions (Vasculitis Damage Index)
during the study
Renal function at 12 months
during the study
Kidney survival at 12 months
during the study
Patient survival at 12 months
during the study
Blood pressure
during th study
Cyclophosphamide
Cyclophosphamide
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hôpital LARIBOISIERE
Paris, 75015, France
Pillebout E, Thervet E, Hill G, Alberti C, Vanhille P, Nochy D. Henoch-Schonlein Purpura in adults: outcome and prognostic factors. J Am Soc Nephrol. 2002 May;13(5):1271-8. doi: 10.1097/01.asn.0000013883.99976.22.
Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.
Eric THERVET, MD
Assistance Publique - Hôpitaux de Paris
200 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
GVHD Prophylaxis With Post Transplant Cyclophosphamide for Patients With Renal Insufficiency Undergoing a Conventional 8/8 HLA-matched Related or Unrelated Donor Allogeneic Hematopoietic Stem Cell Transplant
Contact the study team to confirm eligibility.
Pillebout E, Alberti C, Guillevin L, Ouslimani A, Thervet E; CESAR study group. Addition of cyclophosphamide to steroids provides no benefit compared with steroids alone in treating adult patients with severe Henoch Schonlein Purpura. Kidney Int. 2010 Sep;78(5):495-502. doi: 10.1038/ki.2010.150. Epub 2010 May 26.
Primary Completion
January 2008
Actual (reported)Study Completion
January 2008
Actual (reported)Last Updated
May 4, 2011
Record last verified: 2007-03
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Source: ClinicalTrials.gov.
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