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CompletedNCT00437463Updated Nov 18, 2010

Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor

A Phase 3 interventional study of Ramipril in Glomerulonephritis, sponsored by Sanofi. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-11-18.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.

02

Conditions studied

  • Glomerulonephritis

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03

In context

Glomerulonephritis

149 studies on the registry are indexed under Glomerulonephritis; 38 are open to participants now.

This study's enrollment of 60 is above the median of 40 across 112 interventional studies indexed under Glomerulonephritis.

Browse Glomerulonephritis studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • biopsy-confirmed IgA nephropathy
  • proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l

Exclusion criteria

Exclusion Criteria:

  • pregnant or nursing mother, or women of childbearing potential without an effective method of birth control
  • history of myocardial infarction, congestive heart failure, or any other medical indication that necessitate the use of ACE inhibitor
  • evidence of clinically significant hepatic, gastrointestinal, autoimmune disease
  • history of malignancy, drug or alcohol abuse
  • participation in any previous trial on ACE inhibitor
  • taking other investigational drugs within the past 30 days
  • known history of sensitivity / allergy to ACE inhibitor

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    1

    Ramipril

    Drug: Ramipril

  • No intervention
    2

Interventions

  • DrugRamipril

    2.5mg and increase to 5mg if patient do not develop symptomatic hypotension

06

What researchers measure

Primary outcomes

  1. Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)

    Time frame: From the beginning to the end of the study

  2. Development of proteinuria

    Time frame: From the beginning to the end of the study

  3. 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation

    Time frame: From the beginning to the end of the study

  4. body weight, blood pressure, pulse

    Time frame: From the beginning to the end of the study

  5. Adverse effects of treatment

    Time frame: From the beginning to the end of the study

07

Study locations

1 site
  • Sanofi-Aventis
    Hong Kong, Hong Kong
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00437463
Lead sponsor
Sanofi
First posted
Feb 21, 2007
Start date
Jul 2004
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Nov 18, 2010

Study contacts

Daniel Yuen
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.

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