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

Overview

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

Full Title of Study: “A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2019

Interventions

  • Drug: prednisone plus cyclophosphamide
    • prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months); supportive care,including ACE-I or ARBs and blood pressure control
  • Drug: Prednisone alone
    • prednisone alone: prednisone(0.5mg/kg/day*6 months); supportive care,including ACE-I or ARBs and blood pressure control

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • the changes of kidney function or death
    • Time Frame: 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 Measures

  • the changes of proteinuria
    • Time Frame: 3,6 ,12, 24 and 36 months or more after treatment

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guangdong Provincial People’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wei Shi, clinical professor – Guangdong Provincial People’s Hospital
  • Overall Official(s)
    • wei shi, MD PhD, Principal Investigator, Guangdong Provincial People’s Hospital

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