IgA NephropathyMAINNCT01854814
The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients
A study testing Mycophenolate mofetil and Losartan in people with IgA Nephropathy, run by Fan Fan Hou at 3 sites in China.
Trial summary
The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of… Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Mycophenolate mofetil and Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 3 sitesChina
- Study dates
- Jul 2013to May 2022
- Phase
- Interventional
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy-proven primary IgA nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria:
- global glomerular sclerosis plus focal segmental glomerular sclerosis ratio ≥50%
- eGFR 30 to 60 ml/min
- Hypertension (blood pressure over 140/90 mmHg or taking antihypertensive drugs)
Who cannot join
- Secondary IgA nephropathy
- Familial IgA nephropathy
- Concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function
- Pregnancy or breasting
- Inability to comply with study and follow-up procedures
Trial locations and contacts
3 sites in 1 country.
China3 sites
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, 510515
The Fourth People's Hospital Shenzhen
Shenzhen, Guangdong, 518000
The Institute of Nephrology, Guangdong Medical College
Zhanjiang, Guangdong, 524001
About this study
Official title: The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study
The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of MMF compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.
- Conditions
- IgA Nephropathy
- Being tested
- Mycophenolate mofetil, Losartan
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan
LosartanDrug
Maximum tolerated labeled dose of Losartan
| Study group | Role | What they receive |
|---|---|---|
| mycophenolate mofetil | Experimental | mycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan Receives: Drug: Mycophenolate mofetil |
| losartan | Active comparator | maximus tolerated labeled dose of losartan Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy
Time to the first occurrence of a component of the composite renal endpoint:
Doubling of serum creatinine or the onset of end stage renal disease (ESRD) [needing chronic dialysis or renal transplantation or renal death]
Measured: 3 years
To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy
A decrease in eGFR of 30% or more and to a level of less than 60 ml/min at the exit visit if the baseline eGFR was 60 ml/min or more.
Or a decrease in eGFR of 50% or more at the exit visit if the baseline eGFR was less than 60 ml/min.
Measured: 3 years
Secondary outcomes (2)
To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy
Changes of urinary protein excretion rate
Measured: 3 years
To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy
Time to 30% reduction in estimated glomerular filtration rate (eGFR); eGFR reduction greater than 5 ml/min/1.73m^2/year
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startJul 2013
- Primary completionFeb 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fan Fan Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fan Fan Hou, Nanfang Hospital, Southern Medical University
- Investigators
- Fan Fan Hou, M.D., PhD, Principal investigator, Division of nephrology, Nanfang Hospital Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854814
- Sponsor's protocol ID
- MAIN
- Acronym
- MAIN
- Status last verified
- Jul 2022
- First submitted
- 9 May 2013
- Last updated
- 11 Jul 2022
- Results posted
- No
Publications
Tang SC, Tang AW, Wong SS, Leung JC, Ho YW, Lai KN. Long-term study of mycophenolate mofetil treatment in IgA nephropathy. Kidney Int. 2010 Mar;77(6):543-9. doi: 10.1038/ki.2009.499. Epub 2009 Dec 23.
PubMed 20032964Frisch G, Lin J, Rosenstock J, Markowitz G, D'Agati V, Radhakrishnan J, Preddie D, Crew J, Valeri A, Appel G. Mycophenolate mofetil (MMF) vs placebo in patients with moderately advanced IgA nephropathy: a double-blind randomized controlled trial. Nephrol Dial Transplant. 2005 Oct;20(10):2139-45. doi: 10.1093/ndt/gfh974. Epub 2005 Jul 19.
PubMed 16030050Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.
PubMed 38864363Hou FF, Xie D, Wang J, Xu X, Yang X, Ai J, Nie S, Liang M, Wang G, Jia N; MAIN Trial Investigators. Effectiveness of Mycophenolate Mofetil Among Patients With Progressive IgA Nephropathy: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2254054. doi: 10.1001/jamanetworkopen.2022.54054.
PubMed 36745456
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mycophenolate Mofetil on Renal Outcomes in Patients With Advanced IgA Nephropathy: a Randomized Open-label Study
- ClinicalTrials.gov ID
- NCT01854814
- Acronym / sponsor ID
- MAIN / MAIN
- Conditions
- IgA Nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Fan Fan HouUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Feb 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 16 May 2013 (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.
The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of MMF compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mycophenolate mofetil | Experimental | Drug: Mycophenolate mofetilmycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan |
| losartan | Active comparator | Drug: Losartanmaximus tolerated labeled dose of losartan |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy-proven primary IgA nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria:
Key exclusion criteria (5 listed)
- Secondary IgA nephropathy
- Familial IgA nephropathy
- Concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function
- Pregnancy or breasting
- Inability to comply with study and follow-up procedures
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 mofetilMycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan | Drug | mycophenolate mofetil |
| LosartanMaximum tolerated labeled dose of Losartan | Drug | losartan |
Primary outcome
To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy
Time frame: 3 years
Time to the first occurrence of a component of the composite renal endpoint: Doubling of serum creatinine or the onset of end stage renal disease (ESRD) [needing chronic dialysis or renal transplantation or renal death]
To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy
Time frame: 3 years
A decrease in eGFR of 30% or more and to a level of less than 60 ml/min at the exit visit if the baseline eGFR was 60 ml/min or more. Or a decrease in eGFR of 50% or more at the exit visit if the baseline eGFR was less than 60 ml/min.
2 secondary outcomes
To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy
Time frame: 3 years
To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy
Time frame: 3 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 11 Jul 2022.
- Background: PubMed 20032964Tang SC, Tang AW, Wong SS, Leung JC, Ho YW, Lai KN. Long-term study of mycophenolate mofetil treatment in IgA nephropathy. Kidney Int. 2010 Mar;77(6):543-9. doi: 10.1038/ki.2009.499. Epub 2009 Dec 23.
- Background: PubMed 16030050Frisch G, Lin J, Rosenstock J, Markowitz G, D'Agati V, Radhakrishnan J, Preddie D, Crew J, Valeri A, Appel G. Mycophenolate mofetil (MMF) vs placebo in patients with moderately advanced IgA nephropathy: a double-blind randomized controlled trial. Nephrol Dial Transplant. 2005 Oct;20(10):2139-45. doi: 10.1093/ndt/gfh974. Epub 2005 Jul 19.
- Derived from this study: PubMed 38864363Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.
- Derived from this study: PubMed 36745456Hou FF, Xie D, Wang J, Xu X, Yang X, Ai J, Nie S, Liang M, Wang G, Jia N; MAIN Trial Investigators. Effectiveness of Mycophenolate Mofetil Among Patients With Progressive IgA Nephropathy: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2254054. doi: 10.1001/jamanetworkopen.2022.54054.
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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.
Fan Fan Hou, M.D., PhD principal investigator
Division of nephrology, Nanfang Hospital Southern Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mycophenolate mofetil and Losartan in people with IgA Nephropathy, run by Fan Fan Hou at 3 sites 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 4 inclusion and 5 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 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy (time frame: 3 years). The study lists 2 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 NCT01854814, which also lists 4 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 11 Jul 2022.