A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy

• ClinicalTrials.gov Identifier: NCT00426348
• Recruitment Status: Completed
• First Posted: January 24, 2007
• Last Update Posted: August 28, 2013
• Sponsor: Guangdong Provincial People's Hospital
• Information provided by (Responsible Party): Wei Shi, Guangdong Provincial People's Hospital

Tracking Information

• First Submitted Date: January 23, 2007
• First Posted Date: January 24, 2007
• Last Update Posted Date: August 28, 2013
• Study Start Date: May 2007
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 6, 2011): urinary protein loss whithin 24 hours [ Time Frame: 2-3years ]
• Original Primary Outcome Measures (submitted: January 23, 2007): proteinuria
• Current Secondary Outcome Measures (submitted: November 6, 2011): renal function(serum Crea or eGFR) deterioration [ Time Frame: 2-3years ]
• Original Secondary Outcome Measures (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: A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Glomerulonephritis
• IGA Nephropathy

Intervention

• Drug: Valsartan
  Valsartan (80-160mg/day)
• Drug: Probucol
  Probucol (750mg/day)
• Drug: Placebo
  Placebo

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 27, 2013): 75
• Original Enrollment: Not Provided
• Actual Study Completion Date: January 2013
• Actual Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT00426348
• Other Study ID Numbers: GPPH200603
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wei Shi, Guangdong Provincial People's Hospital
• Study Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Wei Shi, PhD,MD; Nephrology Dept.,Guangdong General Hospital

• PRS Account: Guangdong Provincial People's Hospital
• Verification Date: August 2013