NCT00426348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

5.7 years

First QC Date

January 23, 2007

Last Update Submit

August 27, 2013

Conditions

GlomerulonephritisIGA Nephropathy

Keywords

IgA nephropathyprobucolvalsartantreatmentantioxidantIGA nephropathy：a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas

Outcome Measures

Primary Outcomes (1)

  • urinary protein loss whithin 24 hours

    2-3years

Secondary Outcomes (1)

  • renal function(serum Crea or eGFR) deterioration

    2-3years

Study Arms (2)

1

ACTIVE COMPARATOR

In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo

Drug: ValsartanDrug: Placebo

2

EXPERIMENTAL

Valsartan(80-160mg/day) + Probucol(750mg/day)

Drug: ValsartanDrug: Probucol

Interventions

ValsartanDRUG

Valsartan (80-160mg/day)

12
ProbucolDRUG

Probucol (750mg/day)

2
PlaceboDRUG

Placebo

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Related Publications (2)

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

    PMID: 38299639DERIVED

  • 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.

    PMID: 24191893DERIVED

MeSH Terms

Conditions

GlomerulonephritisGlomerulonephritis, IGA

Interventions

ValsartanProbucol

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Wei Shi, PhD,MD

    Nephrology Dept.,Guangdong General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of renal division of Guangdong General Hospital

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 24, 2007

Study Start

May 1, 2007

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

CN(1)