Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy (e-TOPplus)

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

Status and phase: Unknown; Phase 4

Conditions: IgA Nephropathy

Treatments: Drug: prednisone alone; Drug: prednisone and cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03218852

GGH2012-36-1

Details and patient eligibility

About

This study is an extended follow-up of the study (ClinicalTrials.gov ID: NCT01758120)-Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.

Enrollment: 133 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: Triple Blind

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133 participants in 2 patient groups

prednisone and cyclophosphamide

Experimental group

Description:

1. prednisone(0.5mg/kg/day\*6 months) 2. cyclophosphamide(1g intravenous use,per 1 month\*6months); 3. supportive care,including ACE-I or ARBs and blood pressure control

Treatment:

Drug: prednisone and cyclophosphamide

prednisone alone

Experimental group

Description:

1. prednisone(0.5mg/kg/day\*6months); 2. supportive care,including ACE-I or ARBs and blood pressure control

Treatment:

Drug: prednisone alone