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

This study is currently recruiting participants.

Verified by Guangdong Provincial People's Hospital, November 2009

First Received: January 23, 2007 Last Updated: November 23, 2009 History of Changes

Sponsor:	Guangdong Provincial People's Hospital
Information provided by:	Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier:	NCT00426348

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：a Kind of Glomerulonephritis,Which IgA is the Dorminant Immunodeposit in Mesangial Areas	Drug: Valsartan Drug: Probucol Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Antioxidants

Drug Information available for: Probucol Valsartan

U.S. FDA Resources

Further study details as provided by Guangdong Provincial People's Hospital:

Primary Outcome Measures:

proteinuria [ Time Frame: 2-3years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

renal function deterioration [ Time Frame: 2-3years ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	May 2007
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo	Drug: Valsartan Valsartan (80-160mg/day) Drug: Placebo Placebo
2: Experimental 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
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426348

Contacts

Contact: Wei Shi, PhD,MD

86-20-8385-0849

weishi_gz@126.com

Locations

China, Guangdong
Guangdong Provincial People's Hospital	Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wei Shi, Ph.D 86-20-8385-0849 weishi_gz@126.com

Sponsors and Collaborators

Guangdong Provincial People's Hospital

Investigators

Principal Investigator:

Wei Shi, PhD,MD

Nephrology Dept.,Guangdong Provincial People's Hospital

More Information

No publications provided

Responsible Party:	Guangdong Provincial People's Hospital ( Wei Shi )
Study ID Numbers:	GPPH200603, No
Study First Received:	January 23, 2007
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00426348 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Guangdong Provincial People's Hospital:

IgA nephropathy
probucol
valsartan
treatment
antioxidant

Additional relevant MeSH terms:

Antimetabolites
Glomerulonephritis
Autoimmune Diseases
Antioxidants
Probucol
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Physiological Effects of Drugs
Cardiovascular Agents

Anticholesteremic Agents
Antihypertensive Agents
Protective Agents
Pharmacologic Actions
Urologic Diseases
Therapeutic Uses
Nephritis
Glomerulonephritis, IGA
Kidney Diseases
Valsartan

ClinicalTrials.gov processed this record on February 04, 2010