Identification of Biomarkers Predictive of Worse Prognosis in Henoch Schonlein Purpura

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01610830
First received: May 31, 2012
Last updated: April 22, 2014
Last verified: July 2012
  Purpose

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.


Condition
Purpura, Schoenlein-Henoch

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Biomarkers Predictive of Worse Prognosis in Henoch Schonlein Purpura

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Renal prognosis [ Time Frame: one time measure after a four hour writing session ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and urine analysis - Skin and kidney biopsies


Estimated Enrollment: 120
Study Start Date: April 2010
Estimated Study Completion Date: July 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group A
have skin involvement +/- an extra renal disease (arthritis, digestive and/or HSP without renal disease. The absence of renal disease is defined by the absence of hypertension (BP <95th percentile for height in children, BP <140/90 mmHg in adults with no known history of hypertension), the absence of hematuria (<5 RBCs per mm3), the absence of proteinuria (proteinuria <0.1 g/24h) and the absence of renal dysfunction (MDRD> 80 ml / min).
group B

HSP with renal impairment, defined by the presence of renal dysfunction (calculated clearance <60 ml/min) and/or proteinuria (daily proteinuria greater than 0.3 g) and/or hematuria (more than 5000 RBC per ml or 5 RBC per mm3). We distinguish:

  • Group B1 patients with moderate renal disease if renal biopsy was not indicated or no evidence of histologic severity in renal biopsy (histological classification class 1 or 25)
  • Group B2 patients with severe renal impairment, with signs of histological severity in renal biopsy (class 3, 4 or 5).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Children or adults, suffering from biopsy-proven HSP.2 groups:

  1. Skin involvement +/- an extra renal disease (arthritis, digestive and/or other), without renal disease. Absence of renal disease is defined by: absence of hypertension (BP <95th percentile for height in children, BP <140/90 mmHg in adults), absence of hematuria (<5 RBCs /mm3 or < 5000 RBCs/ ml), absence of proteinuria (proteinuria <0.1 g/d) and absence of renal dysfunction (MDRD> 80 ml / min)
  2. Renal impairment, defined by the presence of renal dysfunction (calculated clearance <60 ml/min) and/or proteinuria (daily proteinuria greater than 0.3 g) and/or hematuria.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610830

Contacts
Contact: Evangeline Pillebout, MD PhD 33142499631 evangeline.pillebout@sls.aphp.fr
Contact: Renato Monteiro, MD PhD 33157277751 Renato.Monteiro@bichat.inserm.fr

Locations
France
Nephrology Unit - Hôpital St Louis Recruiting
Paris, France, 75010
Contact: Evangeline Pillebout, MD PhD    33142499631    evangeline.pillebout@sls.aphp.fr   
Contact: Renato Monteiro, MD PhD    33157277751    Renato.Monteiro@bichat.inserm.fr   
Principal Investigator: Evangeline Pillebout, MDPhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Evangeline Pillebout, Md PhD APHP - Hôpital St Louis - Paris 10 - France
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01610830     History of Changes
Other Study ID Numbers: HSPRONOSTIC
Study First Received: May 31, 2012
Last Updated: April 22, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Purpura, Schoenlein-Henoch
adults
children
pronostic factors

Additional relevant MeSH terms:
Purpura
Purpura, Schoenlein-Henoch
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Immune Complex Diseases
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014