NCT02160132

A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.

Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus.

Detailed description

It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR\>50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days,with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. Furthermore, as we know, active pathological changes in IgAN,including crescents,necrosis and microthrombus,which may turn fibrosis after three months would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.

Conditions

• Glomerulonephritis, IGA
• Peripapillary Crescent
• Necrosis
• Steroid Nephropathy

Interventions

Type	Name	Description
DRUG	Methylprednisolone(intravenously in the 1st-2nd-3rd month )	Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
DRUG	Methylprednisolone(intravenously in the 1st-3rd-5th month)	Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2014-06-10
• Last updated: 2015-03-03

Locations

6 sites across 1 country: China