Identification of Biomarkers Predictive of Worse Prognosis in Henoch Schonlein Purpura

Purpura, Schoenlein-Henoch Clinical Trial

Official title:

Identification of Biomarkers Predictive of Worse Prognosis in Henoch Schonlein Purpura

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01610830
• Other study ID #: HSPRONOSTIC
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2012
• Last updated: April 22, 2014
• Start date: April 2010
• Est. completion date: July 2014

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Evangeline Pillebout, MD PhD
• Phone: 33142499631
• Email: evangeline.pillebout[@]sls.aphp.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial Summary

Henoch Schonlein Purpura (HSP), vasculitis of small vessels with deposits of IgA, is considered by many authors as the systemic form of Berger's disease (IgA-N). IgA-N is characterized by IgA1 deposits in mesangial areas associated with mesangial proliferation. These two diseases remain the leading cause of ESRD by primitive glomerulopathy in Western countries. In recent years, considerable progress has been made in understanding the pathophysiological mechanisms of IgA-N. However, only a high rate of proteinuria at one year or the presence of severe glomerular inflammation on renal biopsy remain predictors of long term renal function. Moreover, the high variability of HSP clinical expression, from few purpura skin lesions that evolve favourably spontaneously, to rapidly progressive renal failure, remains so far unexplained but suggests the existence of individual genetic susceptibility.

In the first part of the study, we will study key factors based on physiopathological data obtained by our laboratory as well as by other groups. The second part of the study concerns genetic factors. Although the candidate genes that may confer a particular susceptibility to the disease, to progress to ESRD or respond to treatment are many, the genes involved in inflammation or controlling renin-angiotensin system are of particular interest.

We will apply these results by studying patients with HSP showing three distinct phenotypes (HSP with isolated cutaneous purpura or associated with minimal or severe renal disease) at diagnosis and after clinical remission.

The purpose of this study is to assess whether the phenotype at diagnosis is associated with the physiological markers and if one of them predicts a pejorative evolution of renal disease at 1 year. Meanwhile, study of polymorphism of selected genes of interest could allow identification of patients with specific genetic susceptibility or with bad prognosis factors who would be thus eligible for specific treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with HSP whose diagnosis was confirmed by histology of an active skin lesion, who signed the informed consent form or for minors, signature of the holders of parental authority.

Exclusion Criteria:

• Patients who do not have skin lesions; Patients receiving immunosuppressive drugs or steroids for more than 2 weeks; Patients with another diagnosis (platelets<100,000/mm3, bacterial purpura, other systemic disease);

• Patients unable to understand the protocol, refusing to sign the information form or unable to comply with regular follow-up consultation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Purpura
• Purpura, Schoenlein-Henoch

Locations

Country	Name	City	State
France	Nephrology Unit - Hôpital St Louis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal prognosis		one time measure after a four hour writing session	No