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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Antioxidants Kidney Diseases

Drug Information available for: Valsartan Immunoglobulin A

Genetic and Rare Diseases Information Center resources: Berger Disease Glomerulonephritis

U.S. FDA Resources

Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:

urinary protein loss whithin 24 hours [ Time Frame: 2-3years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

renal function(serum Crea or eGFR) deterioration [ Time Frame: 2-3years ] [ Designated as safety issue: No ]


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)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):

Ye Z, Zhang L, Xu L, Shi W, Hu H, Shi X, Zhong W, Hou S, Yan H, Zhang B, Xia Y, Wang W, Feng Z, Wang L, Liang Y. Probucol combined with valsartan in immunoglobulin A nephropathy: a multi-centre, open labelled, randomized controlled study. Nephrology (Carlton). 2014 Jan;19(1):40-6. doi: 10.1111/nep.12177.


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
Health Authority:	China: Ethics Committee

Keywords provided by 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 Antioxidants Probucol Valsartan	Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 30, 2016