The Research of Standard Diagnosis and Treatment for HSPN in Children

Nanjing Children's Hospital

Status and phase: Unknown; Phase 2

Conditions: Henoch-Schoenlein Purpura Nephritis

Treatments: Drug: Mycophenolate mofetil(MMF); Drug: Prednisone; Drug: Methylprednisolone; Drug: Cyclophosphamide(CTX); Drug: Angiotensin-converting enzyme inhibitor(ACEI); Drug: Leflunomide(LEF)

Study type: Interventional

Funder types: Other

Identifiers

NCT02532777

AZhang

Details and patient eligibility

About

This study is performed to evaluate the efficacy and safety of various measures in the treatment of HSPN in children.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 3 patient groups

Prednisone & Cyclophosphamide

Experimental group

Description:

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.

Treatment:

Drug: Angiotensin-converting enzyme inhibitor(ACEI)

Drug: Cyclophosphamide(CTX)

Drug: Prednisone

Drug: Methylprednisolone

Prednisone & Mycophenolate mofetil

Experimental group

Description:

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.

Treatment:

Drug: Angiotensin-converting enzyme inhibitor(ACEI)

Drug: Mycophenolate mofetil(MMF)

Drug: Prednisone

Drug: Methylprednisolone

Prednisone & Leflunomide

Experimental group

Description:

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.

Treatment:

Drug: Leflunomide(LEF)

Drug: Angiotensin-converting enzyme inhibitor(ACEI)

Drug: Prednisone

Drug: Methylprednisolone