A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy - Full Text View

Purpose

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	Drug: Valsartan + Placebo Drug: Valsartan + Probucol	Phase IV

MedlinePlus related topics:

Antioxidants

ChemIDplus related topics:

Valsartan Probucol

U.S. FDA Resources

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

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 Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Valsartan(80-160mg/day) + Placebo	Drug: Valsartan + Placebo Valsartan (80-160mg/day) + Placebo
2: Experimental Valsartan(80-160mg/day) + Probucol(750mg/day)	Drug: Valsartan + Probucol Valsartan (80-160mg/day) + Probucol (750mg/day)

Detailed Description:

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

Outcome Measure: renal function deterioration

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

Responsible Party:	Guangdong Provincial People's Hospital ( Wei Shi )
Study ID Numbers:	GPPH200603, No
First Received:	January 23, 2007
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00426348
Health Authority:	China: Ethics Committee

Keywords provided by Guangdong Provincial People's Hospital:

IgA nephropathy

probucol

valsartan

treatment

antioxidant

Study placed in the following topic categories:

Glomerulonephritis

Probucol

Autoimmune Diseases

Urologic Diseases

Nephritis

Berger disease

Glomerulonephritis, IGA

Kidney Diseases

Valsartan

Additional relevant MeSH terms:

Antimetabolites

Antioxidants

Molecular Mechanisms of Pharmacological Action

Immune System Diseases

Therapeutic Uses

Antilipemic Agents

Physiological Effects of Drugs

Cardiovascular Agents

Anticholesteremic Agents

Antihypertensive Agents

Protective Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

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