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

Primary Purpose

Glomerulonephritis, IGA Nephropathy

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Valsartan
Probucol
Placebo
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glomerulonephritis focused on measuring IgA nephropathy, probucol, valsartan, treatment, antioxidant, IGA nephropathy：a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangdong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo

Valsartan(80-160mg/day) + Probucol(750mg/day)

Outcomes

Primary Outcome Measures

urinary protein loss whithin 24 hours

Secondary Outcome Measures

renal function(serum Crea or eGFR) deterioration

Full Information

First Posted
January 23, 2007
Last Updated
August 27, 2013
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00426348
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, IGA Nephropathy
Keywords
IgA nephropathy, probucol, valsartan, treatment, antioxidant, IGA nephropathy：a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
Valsartan(80-160mg/day) + Probucol(750mg/day)
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Description
Valsartan (80-160mg/day)
Intervention Type
Drug
Intervention Name(s)
Probucol
Intervention Description
Probucol (750mg/day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
urinary protein loss whithin 24 hours
Time Frame
2-3years
Secondary Outcome Measure Information:
Title
renal function(serum Crea or eGFR) deterioration
Time Frame
2-3years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Shi, PhD,MD
Organizational Affiliation
Nephrology Dept.,Guangdong General 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

Citations:
PubMed Identifier
24191893
Citation
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.
Results Reference
derived

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

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