Biopsy-confirmed IgA NephropathyPhase 3NCT01225445
Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
A Phase 3 study testing Ramipril in people with Biopsy-confirmed IgA Nephropathy and Proteinuria Less Than 0.5 g Per Day, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. The treatment of IgA nephropathy with normal renal function and minimal proteinuria is unknown. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Biopsy-confirmed IgA Nephropathy, Proteinuria Less Than 0.5 g Per Day, Normal Blood Pressure
- 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
- Apr 2002to Oct 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age between 18 and 65
- biopsy-confirmed IgA nephropathy
- proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 umol/l
- willingness to give written informed consent and willingness to participate in and comply with the study protocol
Who cannot join
- expected survival less than 2 years
- 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
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- taking other investigational drugs within the past 30 days
- history of non-compliance to medical regimens and patients who are considered potentially unreliable
- known history of sensitivity / allergy to ACE inhibitor
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin
About this study
Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. The treatment of IgA nephropathy with normal renal function and minimal proteinuria is unknown. Since angiotensin-converting enzyme (ACE) inhibitors reduce proteinuria and retard the rate of decline of renal function in chronic proteinuric nephropathies, including IgA nephropathy. The investigators conduct a randomized control study to evaluate the efficacy of ACE inhibitor in the treatment of early IgA nephropathy. Sixty patients with biopsy-proven IgA nephropathy and minimal proteinuria are recruited. They will be randomized to ramipril for 5 years or no treatment. Blood pressure, proteinuria and renal function will be monitored. This study will explore the effects of ACE inhibitor in the treatment of early IgA nephropathy, which is a major cause of dialysis-dependent renal failure.
- Conditions
- Biopsy-confirmed IgA Nephropathy, Proteinuria Less Than 0.5 g Per Day, Normal Blood Pressure, Serum Creatinine Below 120 Umol/l
- Being tested
- Ramipril
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamiprilDrug
2.5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | ramipril 2.5 mg daily Receives: Drug: Ramipril |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: 5 years
proteinuria
over 1 g/day
Measured: 5 years
serum creatinine
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startApr 2002
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biopsy-confirmed IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Cheuk Chun Szeto, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01225445
- Sponsor's protocol ID
- HOE 498/6015
- Status last verified
- Apr 2002
- First submitted
- 20 Oct 2010
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Early Immunoglobulin A Nephropathy by Angiotensin Converting Enzyme Inhibitor - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01225445
- Acronym / sponsor ID
- HOE 498/6015
- Conditions
- Biopsy-confirmed IgA Nephropathy, Proteinuria Less Than 0.5 g Per Day, Normal Blood Pressure, Serum Creatinine Below 120 Umol/l
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Oct 2010 (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.
Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. The treatment of IgA nephropathy with normal renal function and minimal proteinuria is unknown. Since angiotensin-converting enzyme (ACE) inhibitors reduce proteinuria and retard the rate of decline of renal function in chronic proteinuric nephropathies, including IgA nephropathy. The investigators conduct a randomized control study to evaluate the efficacy of ACE inhibitor in the treatment of early IgA nephropathy. Sixty patients with biopsy-proven IgA nephropathy and minimal proteinuria are recruited. They will be randomized to ramipril for 5 years or no treatment. Blood pressure, proteinuria and renal function will be monitored. This study will explore the effects of ACE inhibitor in the treatment of early IgA nephropathy, which is a major cause of dialysis-dependent renal failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Ramiprilramipril 2.5 mg daily |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 18 and 65
- biopsy-confirmed IgA nephropathy
- proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 umol/l
- willingness to give written informed consent and willingness to participate in and comply with the study protocol
Key exclusion criteria (9 listed)
- expected survival less than 2 years
- 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
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 |
|---|---|---|
| Ramipril2.5 mg daily | Drug | Treatment |
Primary outcome
blood pressure
Time frame: 5 years
proteinuria
Time frame: 5 years
over 1 g/day
serum creatinine
Time frame: 5 years
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 21 Oct 2010.
- Derived from this study: PubMed 38299639Tunnicliffe 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.
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.
Cheuk Chun Szeto, MD principal investigator
Chinese University of Hong Kong
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 Biopsy-confirmed IgA Nephropathy and Proteinuria Less Than 0.5 g Per Day, run by Chinese University of Hong Kong 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 4 inclusion and 9 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 21 Oct 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?
blood pressure (time frame: 5 years). The study lists 3 primary outcomes in all. 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 NCT01225445, which also lists 1 linked publication.
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 21 Oct 2010.