Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy

Phase 4

• Conditions: IgA Nephropathy
• Interventions: Drug: prednisone plus cyclophosphamide; Drug: Prednisone alone

• Registration Number: NCT01758120
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-25
• Study First Posted: 2013-01-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-14
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

• biopsy-proven primary IgA nephropathy;
• 18-70 years old;
• elevated serum Creatinine and less than 3.0mg/dl;
• with a written consent from participants to receive prednisone and/or cyclophosphamide

Exclusion Criteria

• diabetes;
• contraindications for the treatment of prednisone and/or cyclophosphamide;
• any treatment with steroids or immunosuppressive drugs prior to this study;
• acute deterioration of renal function(including those of glomerular origin)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prednisone plus cyclophosphamide	prednisone plus cyclophosphamide	prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day\*6 months) plus cyclophosphamide(1g intravenous use,per 1 month\*6months)
prednisone alone	Prednisone alone	prednisone alone: prednisone(0.5mg/kg/day\*6 months)

Primary Outcome Measures

Name	Time	Method
the changes of kidney function or death	3,6 ,12, 24 and 36 months or more after treatment	the changes of estimated glomerular filtration rate (eGFR) or a combination of reaching end-stage renal disease (ESRD) or doubling of serum Creatinine or death

Secondary Outcome Measures

Name	Time	Method
the changes of proteinuria	3,6 ,12, 24 and 36 months or more after treatment

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China