The Research of Standard Diagnosis and Treatment for HSPN in Children

Phase 2

• Conditions: Henoch-Schoenlein Purpura Nephritis
• Interventions: Drug: Prednisone; Drug: Cyclophosphamide(CTX); Drug: Mycophenolate mofetil(MMF); Drug: Leflunomide(LEF); Drug: Angiotensin-converting enzyme inhibitor(ACEI); Drug: Methylprednisolone

• Registration Number: NCT02532777
• Lead Sponsor: Nanjing Children's Hospital

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-23
• Study First Posted: 2015-08-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Renal biopsy proved HSPN Proteinuria ≥ 50 mg/kg/d

Exclusion Criteria

• The children with congenital diseases Proteinuria < 50 mg/kg/d

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone & Cyclophosphamide	Prednisone	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.
Prednisone & Cyclophosphamide	Cyclophosphamide(CTX)	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.
Prednisone & Cyclophosphamide	Angiotensin-converting enzyme inhibitor(ACEI)	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.
Prednisone & Cyclophosphamide	Methylprednisolone	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.
Prednisone & Mycophenolate mofetil	Mycophenolate mofetil(MMF)	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.
Prednisone & Mycophenolate mofetil	Angiotensin-converting enzyme inhibitor(ACEI)	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.
Prednisone & Mycophenolate mofetil	Methylprednisolone	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.
Prednisone & Leflunomide	Prednisone	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.
Prednisone & Leflunomide	Leflunomide(LEF)	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.
Prednisone & Leflunomide	Angiotensin-converting enzyme inhibitor(ACEI)	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.
Prednisone & Leflunomide	Methylprednisolone	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.
Prednisone & Mycophenolate mofetil	Prednisone	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.

Primary Outcome Measures

Name	Time	Method
Disappearance of proteinuria	30 mo	The proteinuria is \< 150mg/d

Secondary Outcome Measures

Name	Time	Method
Disappearance of hematuria	30 mo	The number of red blood cells is \< 3 in each high power field of vision
Renal function	30 mo	The glomerular filtration rate is normal

Trial Locations

Locations (1)

Nanjing Children's Hospital; 🇨🇳 Nanjing, Jiangsu, China