The Research of Standard Diagnosis and Treatment for Henoch-Schonlein Purpura Nephritis in Children
Overview
- Phase
- Phase 2
- Intervention
- Prednisone
- Conditions
- Henoch-Schoenlein Purpura Nephritis
- Sponsor
- Nanjing Children's Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Disappearance of proteinuria
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Aihua Zhang
Hospital vice president
Nanjing Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d
Exclusion Criteria
- •The children with congenital diseases Proteinuria \< 50 mg/kg/d
Arms & Interventions
Prednisone & Cyclophosphamide
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.
Intervention: Prednisone
Prednisone & Cyclophosphamide
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.
Intervention: Cyclophosphamide(CTX)
Prednisone & Cyclophosphamide
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.
Intervention: Angiotensin-converting enzyme inhibitor(ACEI)
Prednisone & Cyclophosphamide
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.
Intervention: Methylprednisolone
Prednisone & Mycophenolate mofetil
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.
Intervention: Prednisone
Prednisone & Mycophenolate mofetil
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.
Intervention: Mycophenolate mofetil(MMF)
Prednisone & Mycophenolate mofetil
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.
Intervention: Angiotensin-converting enzyme inhibitor(ACEI)
Prednisone & Mycophenolate mofetil
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.
Intervention: Methylprednisolone
Prednisone & Leflunomide
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.
Intervention: Prednisone
Prednisone & Leflunomide
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.
Intervention: Leflunomide(LEF)
Prednisone & Leflunomide
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.
Intervention: Angiotensin-converting enzyme inhibitor(ACEI)
Prednisone & Leflunomide
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.
Intervention: Methylprednisolone
Outcomes
Primary Outcomes
Disappearance of proteinuria
Time Frame: 30 mo
The proteinuria is \< 150mg/d
Secondary Outcomes
- Disappearance of hematuria(30 mo)
- Renal function(30 mo)