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GlomerulonephritisPhase 4NCT00426348

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

A Phase 4 study testing Valsartan and Probucol in people with Glomerulonephritis and IGA Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Glomerulonephritis, IGA Nephropathy
What is being tested?
Valsartan and Probucol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
75 participants
Where
1 siteChina
Study dates
May 2007to Jan 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: A Prospective Randomized, Controlled, Double Blinded Trial 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.

Being tested
Valsartan, Probucol, Placebo
Keywords
IgA nephropathy, probucol, valsartan, treatment, antioxidant, IGA nephropathy：a kind of glomerulonephritis,which IgA is the dominant immunodeposit in mesangial areas
Medical subject headings
Glomerulonephritis, Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ValsartanDrug

    Valsartan (80-160mg/day)

  • ProbucolDrug

    Probucol (750mg/day)

  • PlaceboDrug

    Placebo

Study groups in NCT00426348
Study groupRoleWhat they receive
1Active comparatorIn arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
Receives: Drug: Valsartan; Drug: Placebo
2ExperimentalValsartan(80-160mg/day) + Probucol(750mg/day)
Receives: Drug: Valsartan; Drug: Probucol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. urinary protein loss whithin 24 hours

    Measured: 2-3years

Secondary outcomes (1)

  1. renal function(serum Crea or eGFR) deterioration

    Measured: 2-3years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00426348
Sponsor's protocol ID
GPPH200603
Status last verified
Aug 2013
First submitted
23 Jan 2007
Last updated
28 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38299639

  • 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.

    PubMed 24191893

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Valsartan and Probucol in people with Glomerulonephritis and IGA Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

urinary protein loss whithin 24 hours (time frame: 2-3years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00426348, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.

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