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

Information source: Guangdong General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glomerulonephritis; IGA Nephropathy

Intervention: Valsartan (Drug); Probucol (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Guangdong General Hospital

Official(s) and/or principal investigator(s):
Wei Shi, PhD,MD, Principal Investigator, Affiliation: Nephrology Dept.,Guangdong General Hospital

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.

Clinical Details

Official title: A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: urinary protein loss whithin 24 hours

Secondary outcome: renal function(serum Crea or eGFR) deterioration

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Guangdong General Hospital, Guangzhou, Guangdong 510080, China
Additional Information

Starting date: May 2007
Last updated: August 27, 2013

Page last updated: August 20, 2015

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