Henoch Schönlein NephritisNCT02811770
Interest to Perform a Renal Biopsy Early in the Course of the Henoch-Schoenlein Nephritis
An observational study of Henoch Schönlein Nephritis, run by CHU de Reims at 1 site in France.
Trial summary
Henoch-Schönlein (HS) purpura is a common cause of renal glomerular injury in children. This condition is responsible for 10-15% of glomerulonephritis in children. The outcome is generally favorable, but up to 5% of patients develop kidney failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Henoch Schönlein Nephritis
- What is being tested?
- kidney biopsy
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jul 2017
- 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: Study of historical cohort, from different centers in France, known to have a different policy for kidney biopsy in HSN (agreements: Reims, Hôpital Trousseau Paris, Hôpital Robert Debré Paris, Toulouse, Lille, Nantes, Lyon and Necker).
Who may be able to join
- Patients aged under 18 at the time of initial management of HSN
- Patient treated for HSN in a French pediatric nephrology unit
- Initial care between January 2006 and December 2010
- Patient who had or not a kidney biopsy
Who cannot join
- Patients who received treatment with corticosteroids for another complication of HSN or other pathology
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
France, Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Henoch-Schönlein (HS) purpura is a common cause of renal glomerular injury in children. This condition is responsible for 10-15% of glomerulonephritis in children. The outcome is generally favorable, but up to 5% of patients develop kidney failure. The outcome of patients with kidney biopsy is less favorable with 7-50% of them progressing to chronic renal failure.
Prevalence of HS is difficult to determine from literature. Annual incidence is estimated at 6.1 / 100,000 children in the Netherlands and up to 20.4 / 100 000 children in the United Kingdom. The proportion of children with HS who develop renal disease is difficult to determine because the numbers reported in the literature are variable and depend greatly on the type of the reporting center, whether or not specialized in pediatric nephrology. Thus the proportion of renal disease varies from 20% to 100% of children with a HS.
Read more
The treatment of HS nephropathy (HSN) usually depends on the severity of histological lesions but histological classification is discussed and there is currently no consensus. Randomized studies are scarce and often do not allow to draw clear conclusions. A meta-analysis suggested a positive effect of corticosteroids on renal prognosis of severe forms but in this study the definition of renal disease was very heterogeneous. The only classification of the HSN recognized is from the International Study Group of Kidney Disease in Childhood (ISKDC) which is the following: grade I: minimal glomerula abnormalities, grade II: pure proliferation, grade III: crescents/ segmental lesions <50%,grade IV: crescents/ segmental lesions 50 to 75%, grade V: crescents/ segmental lesions > 75%, grade VI: pseudomesangiocapillary. However, this classification is questioned because it ignores other significant histological lesions such as interstitial fibrosis, tubular lesions, glomerular and interstitial inflammation, the appearance of crescents (segmental or totally encompassing the glomerulus, fibrous or cellular), segmental sclerosis, fibrosis and arteriolar appearance in immunofluorescence.
There is currently no consensus on the criteria indicating the initiation of corticosteroid therapy whether oral or intra venous bolus. Some patients with severe clinical and / or histological initial presentation can evolve to remission spontaneously while others who have more moderate initial symptoms will evolve later to kidney failure. The management is therefore heterogeneous. In France, some centers perform a kidney biopsy almost always before starting treatment (or in the days following the start of treatment), while in other centers's treatment decision is based on the biology resulting from the glomerular disease, kidney biopsy being performed possibly in a second time in case of failure of the initial treatment.
Principal objective of the study: assessment of the interest for the long term outcome of performing early a kidney biopsy (before the establishment of treatment or within 15 days after the start of treatment) in children with HSN compare to kidney biopsy performed later (depending on the response to initial therapy) or not performed.
Secondary objective: assessment of the impact of early kidney biopsy (before the establishment of treatment or within of 15 days after the start of treatment) on the initial treatment HSN : does it modify or not the treatment started right before it (decided on clinical and biological criteria).
Read the detailed description
If in the past the HSN could be considered a rather benign disease not requiring specific active treatment, the studies evaluating the long-term outcome have shown the risk of progression to Chronic Kidney Disease (CKD) and have lead to recommend the use of corticosteroids and immunosuppressors even in not rapidly progressive glomerulonephritis forms (24,25). Unfortunately clinical studies are scarce, often with few patients and uncontrolled (17,26,27). However, the efficacy of methylprednisolone pulses followed by oral steroids has been suggested in several studies, as in the study conducted at the Hospital Necker, where prospective patients receiving pulses of methylprednisolone were compared to an historical cohort from the same center (28) in a control arm of a randomized controlled trial (29), and in studies where patients received combinations of several immunosuppressive drugs (30-32).
Thus, the current French way to manage severe HSN is to give methylprednisolone pulses followed by oral steroids. Anti-proteinuric medications are for initially mild forms or sequelae. Immunosuppressor is added to steroid in the forms not responding well to initial corticosteroid therapy.
If these therapies are used by most of pediatric teams, practice in kidney biopsy (KB) varies from one center to another. Some teams routinely perform KB before the start of steroid therapy (and adapt the treatment to the results), while others first establish the treatment and perform the KB only if the evolution is not as expected. This second approach reduces the number of KB since patients with favorable outcome will never be biopsied.
The question is which of these two attitudes is the best. Do the biopsied patients have a better prognosis at 5 years (because the lesions were better evaluated in comparison to clinical evaluation, because the diagnosis was confirmed, despite the risk taken to perform KB, because there is no excess of treatment) than those who were not biopsied at the initial period (with possible errors in assessing the severity of injury ), or is there is no difference (because the treatment is the same whether KB was performed or not, because clinical criteria prevail in the therapeutic decision on histological criteria, because KB may falsely reassure and may lead to stop treatment too early (sample problem)).
The aim of the study is to answer these questions, to improve patients care by identifying the most effective strategy to improve long term prognosis, and to standardize practices to make randomized control trials easier to drive in the future.
- Conditions
- Henoch Schönlein Nephritis
- Being tested
- kidney biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney biopsyOther
| Study group | Role | What they receive |
|---|---|---|
| children with HSN | Not described Receives: Other: kidney biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance to creatinine
Measured: between january 2006 and december 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Henoch Schönlein NephritisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811770
- Sponsor's protocol ID
- PA15131
- Status last verified
- Jul 2016
- First submitted
- 21 Jun 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest to Perform a Renal Biopsy Early in the Course of the Henoch-Schoenlein Nephritis
- ClinicalTrials.gov ID
- NCT02811770
- Acronym / sponsor ID
- PA15131
- Conditions
- Henoch Schönlein Nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jul 2017 (estimated)
- First posted
- 23 Jun 2016 (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-Schönlein (HS) purpura is a common cause of renal glomerular injury in children. This condition is responsible for 10-15% of glomerulonephritis in children. The outcome is generally favorable, but up to 5% of patients develop kidney failure. The outcome of patients with kidney biopsy is less favorable with 7-50% of them progressing to chronic renal failure.
Prevalence of HS is difficult to determine from literature. Annual incidence is estimated at 6.1 / 100,000 children in the Netherlands and up to 20.4 / 100 000 children in the United Kingdom. The proportion of children with HS who develop renal disease is difficult to determine because the numbers reported in the literature are variable and depend greatly on the type of the reporting center, whether or not specialized in pediatric nephrology. Thus the proportion of renal disease varies from 20% to 100% of children with a HS.
The treatment of HS nephropathy (HSN) usually depends on the severity of histological lesions but histological classification is discussed and there is currently no consensus. Randomized studies are scarce and often do not allow to draw clear conclusions. A meta-analysis suggested a positive effect of corticosteroids on renal prognosis of severe forms but in this study the definition of renal disease was very heterogeneous. The only classification of the HSN recognized is from the International Study Group of Kidney Disease in Childhood (ISKDC) which is the following: grade I: minimal glomerula abnormalities, grade II: pure proliferation, grade III: crescents/ segmental lesions <50%,grade IV: crescents/ segmental lesions 50 to 75%, grade V: crescents/ segmental lesions > 75%, grade VI: pseudomesangiocapillary. However, this classification is questioned because it ignores other significant histological lesions such as interstitial fibrosis, tubular lesions, glomerular and interstitial inflammation, the appearance of crescents (segmental or totally encompassing the glomerulus, fibrous or cellular), segmental sclerosis, fibrosis and arteriolar appearance in immunofluorescence.
There is currently no consensus on the criteria indicating the initiation of corticosteroid therapy whether oral or intra venous bolus. Some patients with severe clinical and / or histological initial presentation can evolve to remission spontaneously while others who have more moderate initial symptoms will evolve later to kidney failure. The management is therefore heterogeneous. In France, some centers perform a kidney biopsy almost always before starting treatment (or in the days following the start of treatment), while in other centers's treatment decision is based on the biology resulting from the glomerular disease, kidney biopsy being performed possibly in a second time in case of failure of the initial treatment.
Principal objective of the study: assessment of the interest for the long term outcome of performing early a kidney biopsy (before the establishment of treatment or within 15 days after the start of treatment) in children with HSN compare to kidney biopsy performed later (depending on the response to initial therapy) or not performed.
Secondary objective: assessment of the impact of early kidney biopsy (before the establishment of treatment or within of 15 days after the start of treatment) on the initial treatment HSN : does it modify or not the treatment started right before it (decided on clinical and biological criteria).
Detailed description
If in the past the HSN could be considered a rather benign disease not requiring specific active treatment, the studies evaluating the long-term outcome have shown the risk of progression to Chronic Kidney Disease (CKD) and have lead to recommend the use of corticosteroids and immunosuppressors even in not rapidly progressive glomerulonephritis forms (24,25). Unfortunately clinical studies are scarce, often with few patients and uncontrolled (17,26,27). However, the efficacy of methylprednisolone pulses followed by oral steroids has been suggested in several studies, as in the study conducted at the Hospital Necker, where prospective patients receiving pulses of methylprednisolone were compared to an historical cohort from the same center (28) in a control arm of a randomized controlled trial (29), and in studies where patients received combinations of several immunosuppressive drugs (30-32).
Thus, the current French way to manage severe HSN is to give methylprednisolone pulses followed by oral steroids. Anti-proteinuric medications are for initially mild forms or sequelae. Immunosuppressor is added to steroid in the forms not responding well to initial corticosteroid therapy.
If these therapies are used by most of pediatric teams, practice in kidney biopsy (KB) varies from one center to another. Some teams routinely perform KB before the start of steroid therapy (and adapt the treatment to the results), while others first establish the treatment and perform the KB only if the evolution is not as expected. This second approach reduces the number of KB since patients with favorable outcome will never be biopsied.
The question is which of these two attitudes is the best. Do the biopsied patients have a better prognosis at 5 years (because the lesions were better evaluated in comparison to clinical evaluation, because the diagnosis was confirmed, despite the risk taken to perform KB, because there is no excess of treatment) than those who were not biopsied at the initial period (with possible errors in assessing the severity of injury ), or is there is no difference (because the treatment is the same whether KB was performed or not, because clinical criteria prevail in the therapeutic decision on histological criteria, because KB may falsely reassure and may lead to stop treatment too early (sample problem)).
The aim of the study is to answer these questions, to improve patients care by identifying the most effective strategy to improve long term prognosis, and to standardize practices to make randomized control trials easier to drive in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children with HSN | – | Other: kidney biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study of historical cohort, from different centers in France, known to have a different policy for kidney biopsy in HSN (agreements: Reims, Hôpital Trousseau Paris, Hôpital Robert Debré Paris, Toulouse, Lille, Nantes, Lyon and Necker).
Key inclusion criteria (4 listed)
- Patients aged under 18 at the time of initial management of HSN
- Patient treated for HSN in a French pediatric nephrology unit
- Initial care between January 2006 and December 2010
- Patient who had or not a kidney biopsy
Key exclusion criteria (1 listed)
- Patients who received treatment with corticosteroids for another complication of HSN or other pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kidney biopsy | Other | children with HSN |
Primary outcome
clearance to creatinine
Time frame: between january 2006 and december 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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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.
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 Henoch Schönlein Nephritis, run by CHU de Reims 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 4 inclusion and 1 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 18 Jul 2016. 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 Christine Pietrement (326787505, cpietrement@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clearance to creatinine (time frame: between january 2006 and december 2010). 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 18 Jul 2016.