A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
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ClinicalTrials.gov Identifier: NCT00426348 |
Recruitment Status :
Completed
First Posted : January 24, 2007
Last Update Posted : August 28, 2013
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Sponsor:
Guangdong Provincial People's Hospital
Information provided by (Responsible Party):
Wei Shi, Guangdong Provincial People's Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | January 23, 2007 | |||
First Posted Date ICMJE | January 24, 2007 | |||
Last Update Posted Date | August 28, 2013 | |||
Study Start Date ICMJE | May 2007 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
urinary protein loss whithin 24 hours [ Time Frame: 2-3years ] | |||
Original Primary Outcome Measures ICMJE |
proteinuria | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
renal function(serum Crea or eGFR) deterioration [ Time Frame: 2-3years ] | |||
Original Secondary Outcome Measures ICMJE |
renal function deterioration | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy | |||
Official Title ICMJE | A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy | |||
Brief Summary | a statement of the study hypothesis:the effect of valsartan in patients with IgA nephropathy have been proved,and the efficacy of probucol in combination with valsartan is to be proved in patients with IgA nephropathy. This is a prospective randomized controlled, double blinded pilot study to identify the efficacy of probucol in combination with valsartan in patients with IgA nephropathy. The renal function deterioration will be the primary outcome studied. The expected study duration will be 36 months. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Ye Z, Zhang L, Xu L, Shi W, Hu H, Shi X, Zhong W, Hou S, Yan H, Zhang B, Xia Y, Wang W, Feng Z, Wang L, Liang Y. Probucol combined with valsartan in immunoglobulin A nephropathy: a multi-centre, open labelled, randomized controlled study. Nephrology (Carlton). 2014 Jan;19(1):40-6. doi: 10.1111/nep.12177. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
75 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | January 2013 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | China | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00426348 | |||
Other Study ID Numbers ICMJE | GPPH200603 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wei Shi, Guangdong Provincial People's Hospital | |||
Study Sponsor ICMJE | Guangdong Provincial People's Hospital | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Guangdong Provincial People's Hospital | |||
Verification Date | August 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |