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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021275-92 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The objective of this pharmacokinetic study is to examine a possible drug-drug interaction of Pantoprazole on the bioavailability mycophenolic acid.
It is a randomized open-label 4-sequence 4-period pharmacokinetic cross-over study. The objective of the pharmacokinetic study is to examine a drug-drug interaction of pantoprazole on the bioavailability mycophenolic acid administered as either mycophenolate mofetil (Cellcept(R) or mycophenolate Sodium; EC-MPS (Myfortic (R) in stable renal allograft recipients under maintenance immunosuppressive therapy (cyclosporine +/- low dose glucocorticoids).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate mofetil (C) | Active Comparator | Mycophenolate mofetil (C) b.i.d. every 12 hours for 2 weeks. |
|
| Mycophenolate mofetil+Pantoprazole (C+P) | Other | Mycophenolate mofetil b.i.d and Pantoprazole o.m. for 2 weeks. |
|
| Mycophenolate sodium (M) | Other | Mycophenolate sodium (M) b.i.d. every 12 hours for 2 weeks. |
|
| Mycophenolate sodium+Pantoprazole (M+P) | Other | Mycophenolate mofetil b.i.d and Pantoprazole 40mg o.m. for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate sodium | Drug | Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-normalized AUC of Mycophenolic Acid | Bioavailability (12h AUC) of mycophenolic acid in renal transplant patients after administration of MMF+/-PAN and EC-MPS+/-PAN For evaluation of pharmacokinetic and pharmacodynamic parameters blood will be collected before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after drug intake. | Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for PK/PD analysis will be collected. On the next day new treatment starts. There are 4 study visits at the study center. Duration will be approximately 12hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klemens Budde, Prof Dr | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Hospital Campus Mitte | Berlin | 10117 | Germany |
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Recruitment lastet between January 2012 - March 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A |
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| FG001 | Sequence B |
|
| FG002 | Sequence C |
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| FG003 | Sequence D |
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| Period 4 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at transplantation |
| 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 | Dose-normalized AUC of Mycophenolic Acid | Bioavailability (12h AUC) of mycophenolic acid in renal transplant patients after administration of MMF+/-PAN and EC-MPS+/-PAN For evaluation of pharmacokinetic and pharmacodynamic parameters blood will be collected before, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h after drug intake. | Posted | Mean | Standard Deviation | mg*h/L | Study duration for each patient: 2 months. After 10-14 days of drug intake blood samples for PK/PD analysis will be collected. On the next day new treatment starts. There are 4 study visits at the study center. Duration will be approximately 12hours |
|
Adverse event data were collected at every study visit. No follow up data.
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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) | Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks. Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Noro virus infection | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common cold | Immune system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olesja Rissling | Charité University Hospital - Department of Nephrology | +49 30 450 514 153 | olesja.rissling@charite.de |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Pantoprazole | Drug | Daily dose: 40mg. Application together with CellCept® or Myfortic® . |
|
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| Mycophenolate mofetil | Drug | Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® . |
|
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
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| BG001 | Sequence B |
|
| BG002 | Sequence C |
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| BG003 | Sequence D |
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| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| y |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Age at study enrollment | Mean | Standard Deviation | years |
|
| MMF+PAN |
Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks. Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg. Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil. Pantoprazole tablet (PAN) once a day in the morning for two weeks. |
| OG002 | EC-MPS | Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks. Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg. |
| OG003 | EC-MPS + PAN | Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks. Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg. Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium. Pantoprazole tablet (PAN) once a day in the morning for two weeks. |
|
|
| 1 |
| 19 |
| 4 |
| 19 |
| EG001 | MMF + PAN | Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks. Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg. Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil. Pantoprazole tablet (PAN) once a day in the morning for two weeks. | 1 | 18 | 3 | 18 |
| EG002 | EC-MPS | Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks. Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg. | 0 | 18 | 2 | 18 |
| EG003 | EC-MPS + PAN | Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks. Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg. Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium. Pantoprazole tablet (PAN) once a day in the morning for two weeks. | 0 | 18 | 2 | 18 |
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |