Clinical trial NCT00426348: A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
Official title: A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glomerulonephritis
IGA Nephropathy
Keywords: IgA nephropathy
probucol
valsartan
treatment
antioxidant
IGA nephropathy：a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2007-01-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: urinary protein loss whithin 24 hours
timeFrame: 2-3years
Secondary outcomes:
measure: renal function(serum Crea or eGFR) deterioration
timeFrame: 2-3years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Nephrology Dept.,Guangdong General Hospital
name: Wei Shi, PhD,MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.