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| ID | Type | Description | Link |
|---|---|---|---|
| IND #48,977 | Other Identifier | Food and Drug Administration | |
| Canadian Control #076948 | Other Identifier | Bureau of Pharmaceutical Assessment - Canada |
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DSMB recommended stopping the trial because of lack of effect.
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| MMF Placebo | Placebo Comparator | Subjects receive MMF placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Mofetil (MMF) | Drug | Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Proteinuria - Uprotein/Creatinine Ratio | Urine protein/creatinine ratio after 6 months treatment with MMF or placebo. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald J Hogg, M.D. | St. Joseph's Hospital and Medical Center, Phoenix | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38864363 | Derived | 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. | |
| 38299639 | Derived | 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. |
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After the 3 months, 58 subjects fulfilled criteria for going into the MMF vs. placebo phase. Six of the 58 subjects were not randomized because the External Advisory Committee/Data Safety Monitoring Board recommended stopping the trial because of lack of effect.
184 subjects were enrolled. 146 subjects completed entry evaluation. 97 subjects fulfilled entry criteria and were started on 3 month course of Omacor and lisinopril. 94 subjects completed the 3 months of treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mycophenolate Mofetil (MMF) | Subjects receive angiotensin-converting enzyme inhibitors (ACEi), fish oil supplements (FOS), and MMF. 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. Mycophenolate Mofetil (MMF) |
| FG001 | Placebo | Subjects receive ACEi and FOS and placebo. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mycophenolate Mofetil (MMF) | Subjects receive ACEi, FOS, and MMF. 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. Mycophenolate Mofetil (MMF) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Proteinuria - Uprotein/Creatinine Ratio | Urine protein/creatinine ratio after 6 months treatment with MMF or placebo. | Posted | Mean | Standard Deviation | ratio | 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. |
|
The trial design is 13 visits over 27 months.
Adverse events assessed at each encounter with subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mycophenolate Mofetil (MMF) | Subjects receive ACEi, FOS, and MMF. 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. Mycophenolate Mofetil (MMF) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| melanoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| backache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron Hogg, M.D. | Saint Joseph's Hospital and Medical Center | 602-406-3246 | ronhogg@gmail.com |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| MMF Placebo | Drug | Placebo only, oral administration |
|
| ACEi | Drug | Administer same as pre-treatment regimen. |
|
|
| FOS | Drug | Administer same as pre-treatment regimen |
|
|
| Pregnancy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Fall in GFR |
|
| Post-therapy hyperflycemia |
|
| Trial terminated |
|
| BG001 | Placebo | Subjects receive ACEi and FOS and placebo. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects receive ACEi and FOS and placebo.
|
|
| Secondary | Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level | Not Posted | 12 months |
| 1 |
| 25 |
| 25 |
| 25 |
| EG001 | Placebo | Subjects receive ACEi and FOS and placebo. | 1 | 27 | 27 | 27 |
| trauma | General disorders | Non-systematic Assessment | motor vehicle accident (mva) |
|
| common cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| edema | General disorders | Systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| sore throat | Infections and infestations | Systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |