GlomerulonephritisPhase 3NCT00437463
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
A Phase 3 study testing Ramipril in people with Glomerulonephritis, run by Sanofi at 1 site in Hong Kong.
Trial summary
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Glomerulonephritis
- What is being tested?
- Ramipril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2004to Sep 2010
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- biopsy-confirmed IgA nephropathy
- proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
- Conditions
- Glomerulonephritis
- Being tested
- Ramipril
- Medical subject headings
- Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ramipril Receives: Drug: Ramipril |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
Measured: From the beginning to the end of the study
Development of proteinuria
Measured: From the beginning to the end of the study
20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation
Measured: From the beginning to the end of the study
body weight, blood pressure, pulse
Measured: From the beginning to the end of the study
Adverse effects of treatment
Measured: From the beginning to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startJul 2004
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlomerulonephritisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel Yuen, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437463
- Sponsor's protocol ID
- HOE498_6015
- Status last verified
- Nov 2010
- First submitted
- 20 Feb 2007
- Last updated
- 18 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00437463
- Acronym / sponsor ID
- HOE498_6015
- Conditions
- Glomerulonephritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RamiprilRamipril |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- biopsy-confirmed IgA nephropathy
- proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramipril2.5mg and increase to 5mg if patient do not develop symptomatic hypotension | Drug | 1 |
Primary outcome
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
Development of proteinuria
Time frame: From the beginning to the end of the study
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
body weight, blood pressure, pulse
Time frame: From the beginning to the end of the study
Adverse effects of treatment
Time frame: From the beginning to the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Yuen study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramipril in people with Glomerulonephritis, run by Sanofi at 1 site in Hong Kong.
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 2 inclusion and 8 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 18 Nov 2010. 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 Hong Kong. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2010.