Back to resultsTreatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy (TOPplus-IgAN)
Primary Purpose
IgA Nephropathy
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
prednisone plus cyclophosphamide
Prednisone alone
Sponsored by
About this trial
This is an interventional treatment trial for IgA Nephropathy focused on measuring IgA nephropathy, Cyclophosphamide, prednisone
Eligibility Criteria
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)
Sites / Locations
- Guangdong General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
prednisone plus cyclophosphamide
prednisone alone
Arm Description
prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months)
prednisone alone: prednisone(0.5mg/kg/day*6 months)
Outcomes
Primary Outcome Measures
the changes of kidney function or death
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
the changes of proteinuria
Full Information
NCT ID
NCT01758120
First Posted
December 12, 2012
Last Updated
July 12, 2017
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01758120
Brief Title
Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
Acronym
TOPplus-IgAN
Official Title
A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
IgA nephropathy, Cyclophosphamide, prednisone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prednisone plus cyclophosphamide
Arm Type
Experimental
Arm Description
prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months)
Arm Title
prednisone alone
Arm Type
Experimental
Arm Description
prednisone alone: prednisone(0.5mg/kg/day*6 months)
Intervention Type
Drug
Intervention Name(s)
prednisone plus cyclophosphamide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisone alone
Intervention Description
prednisone alone: prednisone(0.5mg/kg/day*6 months);
supportive care,including ACE-I or ARBs and blood pressure control
Primary Outcome Measure Information:
Title
the changes of kidney function or death
Description
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
Time Frame
3,6 ,12, 24 and 36 months or more after treatment
Secondary Outcome Measure Information:
Title
the changes of proteinuria
Time Frame
3,6 ,12, 24 and 36 months or more after treatment
Other Pre-specified Outcome Measures:
Title
Number of Participants with Adverse Events
Description
Number of Participants with Adverse Events; adverse events include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis.
Time Frame
1,3,6 ,12, 24 and 36 months or more after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
wei shi, MD PhD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
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