Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy (TOPplus-IgAN)

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status and phase: Unknown; Phase 4

Conditions: IgA Nephropathy

Treatments: Drug: prednisone plus cyclophosphamide; Drug: Prednisone alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01758120

GGH2012-36 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 135 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 2 patient groups

prednisone plus cyclophosphamide

Experimental group

Description:

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

Treatment:

Drug: prednisone plus cyclophosphamide

prednisone alone

Experimental group

Description:

prednisone alone: prednisone(0.5mg/kg/day\*6 months)

Treatment:

Drug: Prednisone alone