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

Study Overview
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Brief Summary
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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.

Official Title
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An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: prednisone and cyclophosphamide
* Drug: prednisone alone


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prednisone and cyclophosphamide<br>prednisone(0.5mg/kg/day*6 months) cyclophosphamide(1g intravenous use,per 1 month*6months); supportive care,including ACE-I or ARBs and blood pressure control | Drug: prednisone and cyclophosphamide<br>* Prednisone and cyclophosphamide are both administered to participants in this group.<br>|
| Experimental: prednisone alone<br>prednisone(0.5mg/kg/day*6months); supportive care,including ACE-I or ARBs and blood pressure control | Drug: prednisone alone<br>* Prednisone is administered to participants in this group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of kidney function or death | addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of 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 | a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the changes of proteinuria | addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment the changes of proteinuria | a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120) | 
| Number of Participants with Adverse Events | addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment Number of Participants with Adverse Events; adverse events include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis. | a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120) |