An observational study in Purpura, Schoenlein-Henoch, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2014-04-23.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.
This study's planned enrollment of 120 is below the median of 300 across 17 observational studies indexed under IgA Vasculitis.
Browse IgA Vasculitis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Children or adults, suffering from biopsy-proven HSP.2 groups:
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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).
Renal prognosis
Time frame: one time measure after a four hour writing session
This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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