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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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glomerulonephritis IGA Nephropathy | Drug: Valsartan Drug: Probucol Drug: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 75 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | January 2013 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
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Drug: Valsartan
Valsartan (80-160mg/day) Drug: Placebo Placebo |
Experimental: 2
Valsartan(80-160mg/day) + Probucol(750mg/day)
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Drug: Valsartan
Valsartan (80-160mg/day) Drug: Probucol Probucol (750mg/day) |
- urinary protein loss whithin 24 hours [ Time Frame: 2-3years ]
- renal function(serum Crea or eGFR) deterioration [ Time Frame: 2-3years ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426348
China, Guangdong | |
Guangdong General Hospital | |
Guangzhou, Guangdong, China, 510080 |
Principal Investigator: | Wei Shi, PhD,MD | Nephrology Dept.,Guangdong General Hospital |
Responsible Party: | Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong Provincial People's Hospital |
ClinicalTrials.gov Identifier: | NCT00426348 |
Other Study ID Numbers: |
GPPH200603 |
First Posted: | January 24, 2007 Key Record Dates |
Last Update Posted: | August 28, 2013 |
Last Verified: | August 2013 |
IgA nephropathy probucol valsartan |
treatment antioxidant IGA nephropathy:a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas |
Kidney Diseases Glomerulonephritis, IGA Glomerulonephritis Urologic Diseases Nephritis Autoimmune Diseases Immune System Diseases Valsartan Probucol Antihypertensive Agents |
Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents Antioxidants Protective Agents Physiological Effects of Drugs |