IGA NephropathyPhase 4NCT00863252
Mycophenolate Mofetil for IgA Nephropathy
A Phase 4 study testing mycophenolate mofetil and angiotensin blockade in people with IGA Nephropathy, run by The University of Hong Kong at 1 site in China.
Trial summary
IgA nephropathy (IgAN) is the commonest primary glomerulonephritis worldwide. In Hong Kong, IgAN accounts for approximately 30% of all primary glomerular diseases, and a significant proportion of young patients (< 50 years of age) on dialysis therapy are sufferers of primary IgAN. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IGA Nephropathy
- What is being tested?
- mycophenolate mofetil and angiotensin blockade
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Mar 2002to Mar 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between the ages of 18 and 70 years
- Renal biopsy showing a histological diagnosis IgAN, with predominant or codominant mesangial deposition of IgA on immunofluorescent studies
- Daily urinary protein excretion > 1 g on at least 3 separate occasions
- Serum creatinine < 400 umol/L
- Patients who are willing to give written informed consent and to participate in and comply with the study protocol
Who cannot join
- Presence of concomitant glomerular diseases
- Patients with known hypersensitivity to MMF
- Patients receiving treatment with other cytotoxic agents
- Serum creatinine > 400 umol/L
- Women who are lactating, pregnant or of childbearing potential not using, or who are unwilling to use, a reliable contraceptive method during and for 6 weeks following conclusion of MMF therapy. A pregnancy test to exclude pregnancy will be performed for women of childbearing potential prior to recruitment
- Patients who are unable or unwilling to give written informed consent and to participate in and comply with the study protocol
- Presence of systemic infection or malignancy requiring therapy at the time of entry to the study
- Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medicine and Geriatrics, United Christian Hospital
Hong Kong
About this study
Official title: A Prospective, Randomized, Open Label, Case-Controlled Study on the Efficacy of Mycophenolate Mofetil for IgA Nephropathy Patients With Heavy Proteinuria Despite Angiotensin Blockade
IgA nephropathy (IgAN) is the commonest primary glomerulonephritis worldwide. In Hong Kong, IgAN accounts for approximately 30% of all primary glomerular diseases, and a significant proportion of young patients (< 50 years of age) on dialysis therapy are sufferers of primary IgAN. To date, no specific therapeutic agent has been consistently shown to halt the progression of IgAN to end-stage renal failure, particularly in patients with persistent significant proteinuria and the presence of chronic tubulointerstitial inflammation on kidney biopsy. In recent years, angiotensin-converting enzyme inhibitors (ACEI) have been found capable of significantly reducing proteinuria in some IgAN patients, while others, particularly those with the ACE DD genotype, showed either absent or unsatisfactory response to angiotensin blockade. Mycophenolate mofetil (MMF) is a marketed immunosuppressive drug which acts by releasing mycophenolic acid (MPA) to inhibit the de novo pathway of purine synthesis, and hence is relatively selective for lymphocytes. Apart from being efficacious for the prophylaxis of renal allograft rejection and for the induction of remission in severe lupus nephritis, MMF has been anecdotally reported to avert progression to allograft failure in recurrent IgAN of the transplanted kidney. Data on the clinical efficacy of MMF in the treatment of primary IgAN, however, is lacking. In the current proposal, we aim to study the clinical efficacy of MMF in patients with biopsy-proven IgAN and clinically significant proteinuria despite angiotensin blockade. Patients will be followed up for at least 5 years to track any survival difference between groups.
Read the detailed description
(i) STUDY DESIGN
This will be a prospective, randomized, open-label, case-controlled study. Patients of either gender with biopsy-proven IgAN and clinically significant proteinuria despite being on ACEI treatment will be potential candidates (see selection criteria). Eligible patients will be randomized into either of the following groups:
Group I (Intervention arm):
Patients will be given MMF at a daily dose of 1.5 g orally in 2 divided doses in addition to concurrent medications, including ACEI. Duration of therapy is expected to be six months.
Group II (Control arm):
Patient will continue to receive all concurrent medications, including ACEI or angiotensin receptor blocker, at the discretion of the attending renal physician.
(ii) PATIENT SELECTION CRITERIA Inclusion criteria
- Males or females between the ages of 18 and 70 years
- Renal biopsy showing a histological diagnosis IgAN, with predominant or codominant mesangial deposition of IgA on immunofluorescent studies
- Daily urinary protein excretion > 1 g on at least 3 separate occasions
- Serum creatinine < 400 umol/L
- Patients who are willing to give written informed consent and to participate in and comply with the study protocol
Exclusion criteria
- Presence of concomitant glomerular diseases
- Patients with known hypersensitivity to MMF
- Patients receiving treatment with other cytotoxic agents
- Serum creatinine > 400 umol/L
- Women who are lactating, pregnant or of childbearing potential not using, or who are unwilling to use, a reliable contraceptive method during and for 6 weeks following conclusion of MMF therapy. A pregnancy test to exclude pregnancy will be performed for women of childbearing potential prior to recruitment
- Patients who are unable or unwilling to give written informed consent and to participate in and comply with the study protocol
- Presence of systemic infection or malignancy requiring therapy at the time of entry to the study
- Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study (iii) PATIENT MONITORING
Patient record
The record of every recruited patient will contain the following information:
- Demographic data
- Medical history including concomitant illness
- All concomitant medications
- Other significant information
Timing of Assessments
All study assessments will be calculated from the date of study entry. The study follow-up schedule will be as follows:
- Baseline, then
- Two-weekly for the first month, then
- Monthly for the 2nd - 6th month, at the end of which MMF will be withdrawn, then
- Three-monthly until at least 5 years of follow up
- Conditions
- IGA Nephropathy
- Being tested
- mycophenolate mofetil, angiotensin blockade
- Keywords
- proteinuria, creatinine, kidney survival, ESRD
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orally at 0.75 g bd to 1 g bd for 6 months
angiotensin blockadeDrug
Continuation of angiotensin blockade
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MMF Receives: Drug: mycophenolate mofetil |
| 2 | Active comparator | Control Receives: Drug: angiotensin blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour urinary protein excretion
Measured: 18 months to 5 years
Secondary outcomes (1)
Renal survival Serum creatinine level and creatinine clearance Urine albumin-to-creatinine ratio
Measured: at least 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startMar 2002
- Primary completionJun 2004
- Study completionMar 2009
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 IGA NephropathyStudies of the same condition, open and under way.
- More trials run by The 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- United Christian Hospital, Queen Mary Hospital, Hong Kong
- Investigators
- Sydney CW Tang, MD, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863252
- Sponsor's protocol ID
- Roche-ST-01
- Status last verified
- Mar 2009
- First submitted
- 15 Mar 2009
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Tang S, Leung JC, Chan LY, Lui YH, Tang CS, Kan CH, Ho YW, Lai KN. Mycophenolate mofetil alleviates persistent proteinuria in IgA nephropathy. Kidney Int. 2005 Aug;68(2):802-12. doi: 10.1111/j.1523-1755.2005.00460.x.
PubMed 16014059
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Label, Case-Controlled Study on the Efficacy of Mycophenolate Mofetil for IgA Nephropathy Patients With Heavy Proteinuria Despite Angiotensin Blockade
- ClinicalTrials.gov ID
- NCT00863252
- Acronym / sponsor ID
- Roche-ST-01
- Conditions
- IGA Nephropathy
- Keywords
- proteinuria, creatinine, kidney survival, ESRD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- United Christian Hospital, Queen Mary Hospital, Hong Kong
- Study start
- Mar 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Mar 2009 (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.
IgA nephropathy (IgAN) is the commonest primary glomerulonephritis worldwide. In Hong Kong, IgAN accounts for approximately 30% of all primary glomerular diseases, and a significant proportion of young patients (< 50 years of age) on dialysis therapy are sufferers of primary IgAN. To date, no specific therapeutic agent has been consistently shown to halt the progression of IgAN to end-stage renal failure, particularly in patients with persistent significant proteinuria and the presence of chronic tubulointerstitial inflammation on kidney biopsy. In recent years, angiotensin-converting enzyme inhibitors (ACEI) have been found capable of significantly reducing proteinuria in some IgAN patients, while others, particularly those with the ACE DD genotype, showed either absent or unsatisfactory response to angiotensin blockade. Mycophenolate mofetil (MMF) is a marketed immunosuppressive drug which acts by releasing mycophenolic acid (MPA) to inhibit the de novo pathway of purine synthesis, and hence is relatively selective for lymphocytes. Apart from being efficacious for the prophylaxis of renal allograft rejection and for the induction of remission in severe lupus nephritis, MMF has been anecdotally reported to avert progression to allograft failure in recurrent IgAN of the transplanted kidney. Data on the clinical efficacy of MMF in the treatment of primary IgAN, however, is lacking. In the current proposal, we aim to study the clinical efficacy of MMF in patients with biopsy-proven IgAN and clinically significant proteinuria despite angiotensin blockade. Patients will be followed up for at least 5 years to track any survival difference between groups.
Detailed description
(i) STUDY DESIGN
This will be a prospective, randomized, open-label, case-controlled study. Patients of either gender with biopsy-proven IgAN and clinically significant proteinuria despite being on ACEI treatment will be potential candidates (see selection criteria). Eligible patients will be randomized into either of the following groups:
Group I (Intervention arm):
Patients will be given MMF at a daily dose of 1.5 g orally in 2 divided doses in addition to concurrent medications, including ACEI. Duration of therapy is expected to be six months.
Group II (Control arm):
Patient will continue to receive all concurrent medications, including ACEI or angiotensin receptor blocker, at the discretion of the attending renal physician.
(ii) PATIENT SELECTION CRITERIA Inclusion criteria
- Males or females between the ages of 18 and 70 years
- Renal biopsy showing a histological diagnosis IgAN, with predominant or codominant mesangial deposition of IgA on immunofluorescent studies
- Daily urinary protein excretion > 1 g on at least 3 separate occasions
- Serum creatinine < 400 umol/L
- Patients who are willing to give written informed consent and to participate in and comply with the study protocol
Exclusion criteria
- Presence of concomitant glomerular diseases
- Patients with known hypersensitivity to MMF
- Patients receiving treatment with other cytotoxic agents
- Serum creatinine > 400 umol/L
- Women who are lactating, pregnant or of childbearing potential not using, or who are unwilling to use, a reliable contraceptive method during and for 6 weeks following conclusion of MMF therapy. A pregnancy test to exclude pregnancy will be performed for women of childbearing potential prior to recruitment
- Patients who are unable or unwilling to give written informed consent and to participate in and comply with the study protocol
- Presence of systemic infection or malignancy requiring therapy at the time of entry to the study
- Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study (iii) PATIENT MONITORING
Patient record
The record of every recruited patient will contain the following information:
- Demographic data
- Medical history including concomitant illness
- All concomitant medications
- Other significant information
Timing of Assessments
All study assessments will be calculated from the date of study entry. The study follow-up schedule will be as follows:
- Baseline, then
- Two-weekly for the first month, then
- Monthly for the 2nd - 6th month, at the end of which MMF will be withdrawn, then
- Three-monthly until at least 5 years of follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: mycophenolate mofetilMMF |
| 2 | Active comparator | Drug: angiotensin blockadeControl |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females between the ages of 18 and 70 years
- Renal biopsy showing a histological diagnosis IgAN, with predominant or codominant mesangial deposition of IgA on immunofluorescent studies
- Daily urinary protein excretion > 1 g on at least 3 separate occasions
- Serum creatinine < 400 umol/L
- Patients who are willing to give written informed consent and to participate in and comply with the study protocol
Key exclusion criteria (8 listed)
- Presence of concomitant glomerular diseases
- Patients with known hypersensitivity to MMF
- Patients receiving treatment with other cytotoxic agents
- Serum creatinine > 400 umol/L
- Women who are lactating, pregnant or of childbearing potential not using, or who are unwilling to use, a reliable contraceptive method during and for 6 weeks following conclusion of MMF therapy. A pregnancy test to exclude pregnancy will be performed for women of childbearing potential prior to recruitment
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 |
|---|---|---|
| mycophenolate mofetilOrally at 0.75 g bd to 1 g bd for 6 months | Drug | 1 |
| angiotensin blockadeContinuation of angiotensin blockade | Drug | 2 |
Primary outcome
24 hour urinary protein excretion
Time frame: 18 months to 5 years
1 secondary outcome
Renal survival Serum creatinine level and creatinine clearance Urine albumin-to-creatinine ratio
Time frame: at least 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 17 Mar 2009.
- Results publication: PubMed 16014059Tang S, Leung JC, Chan LY, Lui YH, Tang CS, Kan CH, Ho YW, Lai KN. Mycophenolate mofetil alleviates persistent proteinuria in IgA nephropathy. Kidney Int. 2005 Aug;68(2):802-12. doi: 10.1111/j.1523-1755.2005.00460.x.
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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.
Sydney CW Tang, MD, PhD principal investigator
The 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 4 study testing mycophenolate mofetil and angiotensin blockade in people with IGA Nephropathy, run by The University of Hong Kong 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 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 17 Mar 2009. 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?
24 hour urinary protein excretion (time frame: 18 months to 5 years). 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 NCT00863252, 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 17 Mar 2009.