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A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
This study has been completed.
Sponsor:
Guangdong General Hospital
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT00426348
First received: January 23, 2007
Last updated: August 27, 2013
Last verified: August 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Glomerulonephritis IGA Nephropathy | Drug: Valsartan Drug: Probucol Drug: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Wei Shi, Guangdong General Hospital:
Primary Outcome Measures:
- urinary protein loss whithin 24 hours [ Time Frame: 2-3years ]
Secondary Outcome Measures:
- renal function(serum Crea or eGFR) deterioration [ Time Frame: 2-3years ]
| Enrollment: | 75 |
| Study Start Date: | May 2007 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
|
Drug: Valsartan
Valsartan (80-160mg/day)
Drug: Placebo
Placebo
|
|
Experimental: 2
Valsartan(80-160mg/day) + Probucol(750mg/day)
|
Drug: Valsartan
Valsartan (80-160mg/day)
Drug: Probucol
Probucol (750mg/day)
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00426348
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426348
Locations
| China, Guangdong | |
| Guangdong General Hospital | |
| Guangzhou, Guangdong, China, 510080 | |
Sponsors and Collaborators
Guangdong General Hospital
Investigators
| Principal Investigator: | Wei Shi, PhD,MD | Nephrology Dept.,Guangdong General Hospital |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong General Hospital |
| ClinicalTrials.gov Identifier: | NCT00426348 History of Changes |
| Other Study ID Numbers: |
GPPH200603 |
| Study First Received: | January 23, 2007 |
| Last Updated: | August 27, 2013 |
Keywords provided by Wei Shi, Guangdong General Hospital:
|
IgA nephropathy probucol valsartan |
treatment antioxidant IGA nephropathy：a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas |
Additional relevant MeSH terms:
|
Kidney Diseases Glomerulonephritis, IGA Glomerulonephritis Urologic Diseases Nephritis Autoimmune Diseases Immune System Diseases Valsartan Antioxidants Probucol |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents |
ClinicalTrials.gov processed this record on August 22, 2017