IgA NephropathyPhase 3NCT00318474
Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy
A Phase 3 study testing Mycophenolate Mofetil (MMF), ACEi and FOS in people with IgA Nephropathy, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial summary
IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). Read more about this study
- Who is it for?
- Ages 7 to 70 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Mycophenolate Mofetil (MMF), ACEi and FOS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Mar 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ages 7-70 years old
- Renal biopsy, diagnostic for IgA nephropathy
- Must be able to take oral medication
Who cannot join
- Clinical and histologic evidence of systemic lupus erythematosus
- Well-documented history of Henoch-Schonlein purpura.
- Clinical evidence of cirrhosis or chronic liver disease
- Abnormal laboratory values at the time of study entry
- Estimated GFR outside of protocol defined limits
- History of significant gastrointestinal disorder
Show all 9Show fewer
- Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C.
- Other major organ system disease or malignancy
- Current or prior treatment with MMF or azathioprine
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
About this study
Official title: A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy
IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements (FOS).
Read the detailed description
A multi-center, randomized, controlled clinical trial to test the hypothesis that treatment with mycophenolate mofetil (MMF) will lead to significant and sustained improvement in proteinuria in patients with IgA Nephropathy who have been pre-treated (and continue to be treated) with ACEi and FOS compared to a placebo control group of patients receiving comparable doses of ACEi and FOS without MMF. Data for this outcome will be examined every six months and at the end of 2 years of study. Comparisons will be made between the two treatment groups for change from entry level in urine protein to creatinine (UPr/Cr) ratio, 24-hour urine protein excretion rate and estimated glomerular filtration rate (GFR).
- Conditions
- IgA Nephropathy
- Being tested
- Mycophenolate Mofetil (MMF), MMF Placebo, ACEi, FOS
- Keywords
- Proteinuria, Immunoglobulin A
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mycophenolate Mofetil (MMF)Drug
Also called CellCept
Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.
MMF PlaceboDrug
Placebo only, oral administration
ACEiDrug
Also called angiotensin converting enzyme inhibitors
Administer same as pre-treatment regimen.
FOSDrug
Also called fish oil supplement
Administer same as pre-treatment regimen
| Study group | Role | What they receive |
|---|---|---|
| Mycophenolate Mofetil (MMF) | Active comparator | Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months. Receives: Drug: Mycophenolate Mofetil (MMF); Drug: ACEi; Drug: FOS |
| MMF Placebo | Placebo comparator | Subjects receive MMF placebo. Receives: Drug: MMF Placebo; Drug: ACEi; Drug: FOS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proteinuria - Uprotein/Creatinine Ratio
Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.
Measured: Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.
Secondary outcomes (1)
Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startJan 2002
- Primary completionMar 2008
- Study completionMar 2010
Why it stopped: DSMB recommended stopping the trial because of lack of effect.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald J Hogg, M.D., Principal investigator, St. Joseph's Hospital and Medical Center, Phoenix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318474
- Sponsor's protocol ID
- 04PE116
- Other IDs
- IND #48,977, Canadian Control #076948
- Status last verified
- Feb 2016
- First submitted
- 24 Apr 2006
- Last updated
- 7 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Alladin 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 38864363Tunnicliffe 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 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT00318474
- Acronym / sponsor ID
- 04PE116
- Conditions
- IgA Nephropathy
- Keywords
- Proteinuria, Immunoglobulin A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB recommended stopping the trial because of lack of effect.
- Enrolment
- 184 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 26 Apr 2006 (estimated)
- Results
- Posted 1 Oct 2014
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 most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements (FOS).
Detailed description
A multi-center, randomized, controlled clinical trial to test the hypothesis that treatment with mycophenolate mofetil (MMF) will lead to significant and sustained improvement in proteinuria in patients with IgA Nephropathy who have been pre-treated (and continue to be treated) with ACEi and FOS compared to a placebo control group of patients receiving comparable doses of ACEi and FOS without MMF. Data for this outcome will be examined every six months and at the end of 2 years of study. Comparisons will be made between the two treatment groups for change from entry level in urine protein to creatinine (UPr/Cr) ratio, 24-hour urine protein excretion rate and estimated glomerular filtration rate (GFR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mycophenolate Mofetil (MMF) | Active comparator | Drug: Mycophenolate Mofetil (MMF), Drug: ACEi, Drug: FOSDose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months. |
| MMF Placebo | Placebo comparator | Drug: MMF Placebo, Drug: ACEi, Drug: FOSSubjects receive MMF placebo. |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ages 7-70 years old
- Renal biopsy, diagnostic for IgA nephropathy
- Must be able to take oral medication
Key exclusion criteria (9 listed)
- Clinical and histologic evidence of systemic lupus erythematosus
- Well-documented history of Henoch-Schonlein purpura.
- Clinical evidence of cirrhosis or chronic liver disease
- Abnormal laboratory values at the time of study entry
- Estimated GFR outside of protocol defined limits
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 Mofetil (MMF)Also: CellCeptOral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID. | Drug | Mycophenolate Mofetil (MMF) |
| MMF PlaceboPlacebo only, oral administration | Drug | MMF Placebo |
| ACEiAlso: angiotensin converting enzyme inhibitorsAdminister same as pre-treatment regimen. | Drug | MMF Placebo, Mycophenolate Mofetil (MMF) |
| FOSAlso: fish oil supplementAdminister same as pre-treatment regimen | Drug | MMF Placebo, Mycophenolate Mofetil (MMF) |
Primary outcome
Change in Proteinuria - Uprotein/Creatinine Ratio
Time frame: Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.
Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.
1 secondary outcome
Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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.
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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.
Ronald J Hogg, M.D. principal investigator
St. Joseph's Hospital and Medical Center, Phoenix
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 Mycophenolate Mofetil (MMF), ACEi and FOS in people with IgA Nephropathy, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 7 Mar 2016. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Proteinuria - Uprotein/Creatinine Ratio (time frame: Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.). 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 NCT00318474, which also lists 2 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 7 Mar 2016.