A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
Information source: Guangdong Provincial People's Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glomerulonephritis; IGA Nephropathy
Intervention: Valsartan (Drug); Probucol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Guangdong Provincial People's Hospital Official(s) and/or principal investigator(s):
Wei Shi, PhD,MD, Principal Investigator, Affiliation: Nephrology Dept.,Guangdong Provincial People's Hospital
Overall contact:
Wei Shi, PhD,MD, Phone: 86-20-8385-0849, Email: weishi_gz@126.com
Summary
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: proteinuria
Secondary outcome: renal function 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
Wei Shi, PhD,MD, Phone: 86-20-8385-0849, Email: weishi_gz@126.com
Guangdong Provincial People's Hospital, Guangzhou, Guangdong 510080, China; Recruiting
Wei Shi, Ph.D, Phone: 86-20-8385-0849, Email: weishi_gz@126.com
Additional Information
Starting date: May 2007
Ending date: June 2011
Last updated: February 2, 2009
|
