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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001009-41 | EudraCT Number |
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Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of membranous glomerulonephritis it is likely to improve the initial response to treatment and reduce the risk of relapse on stopping therapy.
Membranous nephropathy is a common cause of nephrotic syndrome in adults. It is difficult to treat and if persistent leads to end stage renal failure in a significant number of patients. It is currently treated in this institution with tacrolimus monotherapy. This is effective in the majority of patients in reducing proteinuria but the remissions are often partial and patients tend to relapse when the tacrolimus treatment is stopped. We propose to use mycophenolate mofetil in combination with tacrolimus with the aim of obtaining a more complete initial response to treatment, a decreased rate of relapse on withdrawal of therapy and less progression of renal failure. This will be a randomised control trial, patients will be randomised to receive treatment with tacrolimus alone (our current standard therapy)or treatment with tacrolimus and mycophenolate mofetil. Participants will receive treatment for up to 2 years and then be monitored for relapse of their nephrotic syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tacrolimus | Active Comparator | Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L |
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| tacrolimus and mycophenolate mofetil | Active Comparator | tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Patient Who Gained Remission From the Nephrotic Syndrome | Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy. | 10-109 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Achieved Remission | The degree of remission of proteinuria obtained (complete or partial) The rate of decline of renal function measured by the Modification of Diet in Renal Disease equation for glomerular filtration rate. | 6-12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Megan Griffith, MBChB PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital | London | W12 OHS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31492152 | Result | Nikolopoulou A, Condon M, Turner-Stokes T, Cook HT, Duncan N, Galliford JW, Levy JB, Lightstone L, Pusey CD, Roufosse C, Cairns TD, Griffith ME. Mycophenolate mofetil and tacrolimus versus tacrolimus alone for the treatment of idiopathic membranous glomerulonephritis: a randomised controlled trial. BMC Nephrol. 2019 Sep 6;20(1):352. doi: 10.1186/s12882-019-1539-z. | |
| 34778952 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tacrolimus | Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml |
| FG001 | Tacrolimus and Mycophenolate Mofetil |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2008 |
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| tacrolimus and mycophenolate mofetil | Drug | tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L |
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| von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4. |
tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L
tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tacrolimus | Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml |
| BG001 | Tacrolimus and Mycophenolate Mofetil | tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Serum albumin | Median | Full Range | g/L |
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| Estimated glomerus filtration rate (GRF) | Median | Full Range | mls/min/1.73m^2 |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Patient Who Gained Remission From the Nephrotic Syndrome | Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy. | Posted | Count of Participants | Participants | 10-109 weeks |
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| Secondary | Number of Patients Achieved Remission | The degree of remission of proteinuria obtained (complete or partial) The rate of decline of renal function measured by the Modification of Diet in Renal Disease equation for glomerular filtration rate. | Posted | Count of Participants | Participants | 6-12 months |
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9.5 years
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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 | Tacrolimus | Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml | 0 | 20 | 7 | 20 | 0 | 20 |
| EG001 | Tacrolimus and Mycophenolate Mofetil | tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L | 0 | 20 | 3 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoe and vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Haemorrhoidectomy | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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| Cholestatic jaundice | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Megan Griffith | Imperial College NHS Trust | 02083835272 | megan.griffith1@nhs.net |
| Sep 12, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| D005921 | Glomerulonephritis |
| ID | Term |
|---|---|
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| 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 |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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