Purpura, Schoenlein-HenochNCT01610830
Identification of Biomarkers Predictive of Worse Prognosis in Henoch Schonlein Purpura
An observational study of Purpura, Schoenlein-Henoch, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Purpura, Schoenlein-Henoch
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2010to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nephrology Unit - Hôpital St Louis
Paris, 75010
Evangeline Pillebout, MD PhD, 33142499631, evangeline.pillebout@sls.aphp.fr
Renato Monteiro, MD PhD, 33157277751, Renato.Monteiro@bichat.inserm.fr
About this study
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.
Read more
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.
- Conditions
- Purpura, Schoenlein-Henoch
- Keywords
- Purpura, Schoenlein-Henoch, adults, children, pronostic factors
- Medical subject headings
- IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal prognosis
Measured: one time measure after a four hour writing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startApr 2010
- Primary completionJan 2013
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Purpura, Schoenlein-HenochStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evangeline Pillebout, Md PhD, Principal investigator, APHP - Hôpital St Louis - Paris 10 - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610830
- Sponsor's protocol ID
- HSPRONOSTIC
- Status last verified
- Jul 2012
- First submitted
- 31 May 2012
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers Predictive of Worse Prognosis in Henoch Schonlein Purpura
- ClinicalTrials.gov ID
- NCT01610830
- Acronym / sponsor ID
- HSPRONOSTIC
- Conditions
- Purpura, Schoenlein-Henoch
- Keywords
- Purpura, Schoenlein-Henoch, adults, children, pronostic factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 4 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Renal prognosis
Time frame: one time measure after a four hour writing session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangeline Pillebout, Md PhD principal investigator
APHP - Hôpital St Louis - Paris 10 - France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Purpura, Schoenlein-Henoch, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evangeline Pillebout, MD PhD (33142499631, evangeline.pillebout@sls.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal prognosis (time frame: one time measure after a four hour writing session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2014.