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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Wei Shi, Guangdong General Hospital

ClinicalTrials.gov Identifier:

NCT00426348

First received: January 23, 2007

Last updated: August 27, 2013

Last verified: August 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 23, 2007

Last Updated Date

August 27, 2013

Start Date ^ICMJE

May 2007

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

proteinuria

Change History

Complete list of historical versions of study NCT00426348 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

renal function deterioration

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Glomerulonephritis
IGA Nephropathy

Intervention ^ICMJE

Drug: Valsartan
Valsartan (80-160mg/day)

Other Name: Valsartan
Drug: Probucol
Probucol (750mg/day)
Drug: Placebo
Placebo

Study Arm (s)

Active Comparator: 1
In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
Interventions:
- Drug: Valsartan
- Drug: Placebo
Experimental: 2
Valsartan(80-160mg/day) + Probucol(750mg/day)
Interventions:
- Drug: Valsartan
- Drug: Probucol

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00426348

Other Study ID Numbers ^ICMJE

GPPH200603

Has Data Monitoring Committee

Yes

Responsible Party

Wei Shi, Guangdong General Hospital

Study Sponsor ^ICMJE

Guangdong General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Wei Shi, PhD,MD

Nephrology Dept.,Guangdong General Hospital

Information Provided By

Guangdong General Hospital

Verification Date

August 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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