Efficacy of Steroid Versus Steroid Plus Cyclophosphamide for Severe Henoch-Schoenlein Purpura

NCT00190229 | Completed DMC

• 1 other identifier: P011014
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Henoch-Schoenlein Purpura

Keywords

Vasculitis; Cyclophosphamide; Renal failure

Outcome Measures

Primary Outcomes (1)

• Birmingham Vasculitis Activity Score (BVAS)

  Birmingham Vasculitis Activity Score (BVAS)

  during de study

Secondary Outcomes (7)

• 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

Study Arms (1)

1

EXPERIMENTAL

Cyclophosphamide

Drug: Cyclophosphamide

Interventions

Cyclophosphamide DRUG

Cyclophosphamide

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Henoch-Schoenlein purpura
• Patient's age \> 18 years

You may not qualify if:

• Patient presenting a purpura RHEUMATOID the diagnosis of which is confirmed by the histology presenting at least a visceral infringement(achievement) making consider the affection as engraves(burns)
• of 18 or more years old Patient
• Patient capable of understanding(including) the advantages and the risks of the try
• Patient having given his assent lit in writing

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital LARIBOISIERE

Paris, 75015, France

Location

Related Publications (3)

• 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.

  PMID: 11961015 RESULT

• 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.

  PMID: 36853224 DERIVED

• 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.

  PMID: 20505654 DERIVED

MeSH Terms

Conditions

IgA Vasculitis; Vasculitis; Renal Insufficiency

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Immune Complex Diseases; Hypersensitivity; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Eric THERVET, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: September 1, 2002
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 4, 2011

Record last verified: 2007-03

Locations

FR (1)