Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy (e-TOPplus)
Primary Purpose
IgA Nephropathy
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
prednisone and cyclophosphamide
prednisone alone
Sponsored by
About this trial
This is an interventional treatment trial for IgA Nephropathy
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 and cyclophosphamide
prednisone alone
Arm Description
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
prednisone(0.5mg/kg/day*6months); supportive care,including ACE-I or ARBs and blood pressure control
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT03218852
First Posted
December 7, 2016
Last Updated
July 12, 2017
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03218852
Brief Title
Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
Acronym
e-TOPplus
Official Title
An Extended Follow-up of the 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 2016 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prednisone and cyclophosphamide
Arm Type
Experimental
Arm Description
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
Arm Title
prednisone alone
Arm Type
Experimental
Arm Description
prednisone(0.5mg/kg/day*6months);
supportive care,including ACE-I or ARBs and blood pressure control
Intervention Type
Drug
Intervention Name(s)
prednisone and cyclophosphamide
Intervention Description
Prednisone and cyclophosphamide are both administered to participants in this group.
Intervention Type
Drug
Intervention Name(s)
prednisone alone
Intervention Description
Prednisone is administered to participants in this group.
Primary Outcome Measure Information:
Title
the changes of kidney function or death
Description
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
Time Frame
a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
Secondary Outcome Measure Information:
Title
the changes of proteinuria
Description
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
Time Frame
a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
Title
Number of Participants with Adverse Events
Description
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.
Time Frame
a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
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)
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
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