Henoch-Schoenlein Purpura NephritisPhase 2NCT02532777
The Research of Standard Diagnosis and Treatment for HSPN in Children
A Phase 2 study testing Prednisone, Cyclophosphamide(CTX) and Mycophenolate mofetil(MMF) in people with Henoch-Schoenlein Purpura Nephritis, run by Nanjing Children's Hospital at 1 site in China.
Trial summary
This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Henoch-Schoenlein Purpura Nephritis
- What is being tested?
- Prednisone, Cyclophosphamide(CTX) and Mycophenolate mofetil(MMF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2015to Jul 2020
- Phase
- Phase 2
- 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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d
Who cannot join
- The children with congenital diseases Proteinuria < 50 mg/kg/d
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Children's Hospital
Nanjing, Jiangsu, 210000
Aihua Zhang, M.D., +8618951769017, bszah@163.com
About this study
Official title: The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children
This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
Read the detailed description
Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological marker for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
The patients who are proved to get HSPN by renal biopsy will be given prednisone 2mg/kg/d, and randomized to receive cyclophosphamide pulse i.v.,mycophenolate mofetil p.o. or leflunomide p.o., we will follow up them for about 2.5 years and compare the efficacy and safety of these measures by monitoring several indexes.
- Conditions
- Henoch-Schoenlein Purpura Nephritis
- Being tested
- Prednisone, Cyclophosphamide(CTX), Mycophenolate mofetil(MMF), Leflunomide(LEF), Angiotensin-converting enzyme inhibitor(ACEI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Cyclophosphamide(CTX)Drug
Mycophenolate mofetil(MMF)Drug
Leflunomide(LEF)Drug
Angiotensin-converting enzyme inhibitor(ACEI)Drug
Also called Lotensin
| Study group | Role | What they receive |
|---|---|---|
| Prednisone & Cyclophosphamide | Experimental | Drug: prednisone \& cyclophosphamide \& Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy. Receives: Drug: Prednisone; Drug: Cyclophosphamide(CTX); Drug: Angiotensin-converting enzyme inhibitor(ACEI); Drug: Methylprednisolone |
| Prednisone & Mycophenolate mofetil | Experimental | Drug: prednisone \& mycophenolate mofetil \& Angiotensin-converting enzyme inhibitor(ACEI).
Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy. Receives: Drug: Prednisone; Drug: Mycophenolate mofetil(MMF); Drug: Angiotensin-converting enzyme inhibitor(ACEI); Drug: Methylprednisolone |
| Prednisone & Leflunomide | Experimental | Drug: prednisone \& leflunomide \& Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod.
Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg)，then give the maintaining dose 0.5mg/kg/d.
Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy. Receives: Drug: Prednisone; Drug: Leflunomide(LEF); Drug: Angiotensin-converting enzyme inhibitor(ACEI); Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disappearance of proteinuria
The proteinuria is < 150mg/d
Measured: 30 mo
Secondary outcomes (2)
Disappearance of hematuria
The number of red blood cells is < 3 in each high power field of vision
Measured: 30 mo
Renal function
The glomerular filtration rate is normal
Measured: 30 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Henoch-Schoenlein Purpura NephritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aihua Zhang, Nanjing Children's Hospital
- Investigators
- Aihua Zhang, M.D., Study chair, Department of Nephrology, Nanjing children's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532777
- Sponsor's protocol ID
- AZhang
- Status last verified
- Feb 2020
- First submitted
- 20 Aug 2015
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.
PubMed 36853224
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children
- ClinicalTrials.gov ID
- NCT02532777
- Acronym / sponsor ID
- AZhang
- Conditions
- Henoch-Schoenlein Purpura Nephritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 26 Aug 2015 (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.
This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
Detailed description
Henoch-Schonlein purpura nephritis (HSPN) is one of the most common complications of Henoch-Schonlein purpura, and has become one of the main causes of chronic kidney disease in children. However, the diagnosis and treatment of HSPN is still based on the clinical experience, lacking of evidence-based support. This study is performed to explore the biological marker for early prediction of the prognosis and evaluate the efficacy and safety of various measures in the treatment of HSPN in children.
The patients who are proved to get HSPN by renal biopsy will be given prednisone 2mg/kg/d, and randomized to receive cyclophosphamide pulse i.v.,mycophenolate mofetil p.o. or leflunomide p.o., we will follow up them for about 2.5 years and compare the efficacy and safety of these measures by monitoring several indexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prednisone & Cyclophosphamide | Experimental | Drug: Prednisone, Drug: Cyclophosphamide(CTX), Drug: Angiotensin-converting enzyme inhibitor(ACEI), Drug: MethylprednisoloneDrug: prednisone \& cyclophosphamide \& Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod. cyclophosphamide: 0.1mg/kg. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy. |
| Prednisone & Mycophenolate mofetil | Experimental | Drug: Prednisone, Drug: Mycophenolate mofetil(MMF), Drug: Angiotensin-converting enzyme inhibitor(ACEI), Drug: MethylprednisoloneDrug: prednisone \& mycophenolate mofetil \& Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod. mycophenolate mofetil: 25mg/kg/d bid (the maximum dose is 1.5g/d). Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy. |
| Prednisone & Leflunomide | Experimental | Drug: Prednisone, Drug: Leflunomide(LEF), Drug: Angiotensin-converting enzyme inhibitor(ACEI), Drug: MethylprednisoloneDrug: prednisone \& leflunomide \& Angiotensin-converting enzyme inhibitor(ACEI). Prednisone: 2mg/kg/d (the maximum dose is 60mg) for 6-8 weeks, then two-thirds of the two day's dose qod. Leflunomide: give patients the induction dose 1mg/kg/d for three days (the total dose is under 40mg/kg)，then give the maintaining dose 0.5mg/kg/d. Angiotensin-converting enzyme inhibitor(ACEI): 0.2-0.3mg/kg/d. Methylprednisolone: the children with above 50% crescent in renal biopsy. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d
Key exclusion criteria (1 listed)
- The children with congenital diseases Proteinuria < 50 mg/kg/d
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 |
|---|---|---|
| Prednisone | Drug | Prednisone & Cyclophosphamide, Prednisone & Leflunomide, Prednisone & Mycophenolate mofetil |
| Cyclophosphamide(CTX) | Drug | Prednisone & Cyclophosphamide |
| Mycophenolate mofetil(MMF) | Drug | Prednisone & Mycophenolate mofetil |
| Leflunomide(LEF) | Drug | Prednisone & Leflunomide |
| Angiotensin-converting enzyme inhibitor(ACEI)Also: Lotensin | Drug | Prednisone & Cyclophosphamide, Prednisone & Leflunomide, Prednisone & Mycophenolate mofetil |
| Methylprednisolone | Drug | Prednisone & Cyclophosphamide, Prednisone & Leflunomide, Prednisone & Mycophenolate mofetil |
Primary outcome
Disappearance of proteinuria
Time frame: 30 mo
The proteinuria is < 150mg/d
2 secondary outcomes
Disappearance of hematuria
Time frame: 30 mo
Renal function
Time frame: 30 mo
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Derived from this study: PubMed 36853224Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.
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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.
Aihua Zhang, M.D. study chair
Department of Nephrology, Nanjing children's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisone, Cyclophosphamide(CTX) and Mycophenolate mofetil(MMF) in people with Henoch-Schoenlein Purpura Nephritis, run by Nanjing Children's Hospital at 1 site in China.
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 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 26 Feb 2020. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Aihua Aihua, M.D. (+8618951769017, bszah@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disappearance of proteinuria (time frame: 30 mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532777, which also lists 1 linked publication.
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 26 Feb 2020.