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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
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong Provincial People's Hospital

Tracking Information
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
 (submitted: November 6, 2011)
urinary protein loss whithin 24 hours [ Time Frame: 2-3years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2007)
proteinuria
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2011)
renal function(serum Crea or eGFR) deterioration [ Time Frame: 2-3years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2007)
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.

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
Condition  ICMJE
  • Glomerulonephritis
  • IGA Nephropathy
Intervention  ICMJE
  • Drug: Valsartan
    Valsartan (80-160mg/day)
  • Drug: Probucol
    Probucol (750mg/day)
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: 1
    In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
    Interventions:
    • Drug: Valsartan
    • Drug: Placebo
  • Experimental: 2
    Valsartan(80-160mg/day) + Probucol(750mg/day)
    Interventions:
    • Drug: Valsartan
    • Drug: Probucol
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2013)
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:

  • Patients who fulfill the clinical and pathological criteria for IgA nephropathy
  • Age: 18-60 years
  • Renal biopsy diagnostic for IgA nephropathy based on immunohistologic staining for IgA that is greater than or equal to staining for IgG and IgM
  • Urinary protein excretion rate is within the range of 1-2.5g/day
  • Serum creatinine <265.2umol/L at the time of randomization

Exclusion Criteria:

  • Patients who refuse to be randomized for treatment
  • Patients who prefer treatment with conventional agents
  • Patients who are pregnant or plan for pregnancy
  • Patients who are pathologically proven severely or diffusely proliferative IgA nephropathy or crescent glomerulonephritis with >= 50% segmental involvement of the glomeruli and should be treated with other agents,such as immunosuppressive agents or steroid
  • Clinical and histologic evidence of:

    • systemic lupus erythematosus
    • Henoch-Schonlein purpura
    • cirrhosis
    • chronic active liver disease
    • hepatitis B
    • hepatitis C
    • severe chronic diarrhea
    • active peptic ulcer disease
    • HIV
    • acute renal failure
    • malignant hypertension
    • severe heart diseases
    • malignant tumor
    • any systemic infection
    • pregnancy
    • Known contraindication to the administration of probucol and valsartan
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Wei Shi, PhD,MD Nephrology Dept.,Guangdong General Hospital
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