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NCT Number: NCT00426348

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

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.

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Key information

Conditions

Glomerulonephritis Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis, IGA IgA Nephropathy Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan

Drug

Valsartan (80-160mg/day)

Probucol

Drug

Probucol (750mg/day)

Placebo

Drug

Placebo

Primary outcomes

  1. urinary protein loss whithin 24 hours

    Time frame: 2-3years

Secondary outcomes

  1. renal function(serum Crea or eGFR) deterioration

    Time frame: 2-3years

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jan 24, 2007
Registry last updated
Aug 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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