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| ID | Type | Description | Link |
|---|---|---|---|
| CRAD001AUS209T | Other Grant/Funding Number | Novartis Pharmaceuticals Company |
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low recruitment
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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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Patients who receive renal transplantation at Barnes Jewish Hospital (BJH) are placed on triple maintenance immunosuppression, which means that patients take 3 types of immunosuppression drugs to suppress their immune system including tacrolimus, mycophenolate (MPA), and prednisone. However, due to the effects of MPA on the gastrointestinal tract, patients often complain of GI adverse effects. Current practice is to either dose-reduce MPA or convert the patient to an alternative agent, typically Azathioprine. Both of these strategies have limitations, largely due to concerns related to efficacy. Everolimus (EVR) has demonstrated similar efficacy to MPA in renal transplantation and may offer a benefit related to GI adverse effects, so the investigators will convert patients to EVR in this study. Patients who are within their first year post-transplant will be converted to EVR upon enrollment in the study, and serial measurements ,or a series of measurements looking for an increase or decrease over time, of GI adverse effects will be conducted over 1 year post-enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional (EVR) | Active Comparator | Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus |
|
| Prior Agent (MPA) | Active Comparator | Patient will have baseline data collected while on MPA for comparison with EVR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug |
|
| |
| Mycophenolic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality. | 1, 6, and 12 months |
| Biopsy Proven Acute Rejection |
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Inclusion Criteria:
Exclusion Criteria:
Dual organ or kidney after another solid organ transplant
Presence of a preexisting significant GI condition that does not have a presumed causal relationship with MPA
Evidence of any GI disorder induced by an infection, underlying medical condition, or concomitant medication other than MPA
Estimated glomerular filtration rate (eGFR) <40 ml/min at time of possible conversion
Proteinuria >1 gram/day at time of possible conversion
Profound bone marrow suppression at the time of possible conversion as defined as:
Wound healing issues at time of possible conversion (eg, wound dehiscence, wound infection, incisional hernia, lymphocele, seroma)
Elevated total cholesterol (>350 mg/dL) and/or triglycerides (>500 ng/dL) at time of possible conversion
Hypersensitivity to everolimus, sirolimus, or other rapamycin derivatives
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interventional Everolimus (EVR) | Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus Everolimus |
| FG001 | Prior Agent Mycophenolic Acid (MPA) | Patient will have baseline data collected while on MPA for comparison with EVR Mycophenolic Acid |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
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| ID | Title | Description |
|---|---|---|
| BG000 | Interventional (EVR) | Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus Everolimus |
| BG001 | Prior Agent (MPA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Gastrointestinal Symptom Rating Scale | Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality. | Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality. | Posted | 3 months |
|
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
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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 | Interventional (EVR) | Patients experiencing gastrointestinal adverse effects in the first year post transplant will be converted from mycophenolate to everolimus Everolimus |
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Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. R. Delos Santos | Washington University | 314-362-8351 | delossantos@wustl.edu |
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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 | May 31, 2018 | Aug 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 |
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| Drug |
|
|
Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality.
| 12 months |
Patient will have baseline data collected while on MPA for comparison with EVR
Mycophenolic Acid
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Race (NIH/OMB) |
|
| Region of Enrollment | participants |
|
|
| Secondary | Gastrointestinal Symptom Rating Scale | Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality. | Trial was terminated with only 1 participant enrolled, no data is reported to protect patient confidentiality | Posted | 1, 6, and 12 months |
|
|
| Secondary | Biopsy Proven Acute Rejection | Trial was terminated with only 1 participant enrolled. No data is reported here to maintain patient confidentiality. | Trial was terminated with only 1 participant enrolled, no data is reported to protect patient confidentiality | Posted | 12 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Prior Agent (MPA) | Patient will have baseline data collected while on MPA for comparison with EVR Mycophenolic Acid | 0 | 0 | 0 | 0 | 0 | 0 |
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| Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |