Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the safety and efficacy of a new formulation of Myfortic in combination with tacrolimus and thymoglobulin.
Evaluate the safety and efficacy of Myfortic in combination with tacrolimus and anti-thymocyte globulin in an early corticosteroid withdrawal protocol. Secondary objective is to determine the pharmacokinetic-pharmacodynamic profile of Myfortic in a corticosteroid withdrawal protocol.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolic Acid (Myfortic) Preload | Experimental | Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter |
|
| Mycophenolic Acid (Myfortic) Standard | Active Comparator | Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolic Acid (Myfortic) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of All Biopsy Proven Acute Rejection. | Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Allograft Survival 12 Months | Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rita Alloway, PharmD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Christ Hospital | Cincinnati | Ohio | 45267 | United States | ||
| University of Cincinnati |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Single center, 45 patients consecutively enrolled. Patients were randomized into two groups: (group 1) will be receive 2160 mg/day for two weeks, followed by 1440 mg/day thereafter, and (group 2) will receive 1440 mg/day for the duration of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Myfortic 1080mg BID, 720mg BID | Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter |
| FG001 | Myfortic 720 mg Twice Daily | Myfortic 720 mg twice daily (1440 mg/day). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Myfortic 1080mg BID, 720mg BID | Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter |
| BG001 | Myfortic 720 mg Twice Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of All Biopsy Proven Acute Rejection. | Treatment efficacy, defined as the incidence of all biopsy proven acute rejection. Biopsy was proven with tissue samples collected on patients with elevated serum creatinine | Posted | Number | Participants | 12 months |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mycophenolic Acid Loading Group | Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rita Alloway, PharmD | University of Cincinnati | 5135581568 | rita.alloway@uc.edu |
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Renal Function at 12 Months | Renal function measured by serum creatinine (SCr) at 12 months post-transplant | 12 months |
| Incidence of Post Transplant Infections | Incidence of post transplant infections that resulted in hospitalization | 12 months |
| GI Toxicities | Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic) | 12 months |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
Myfortic 720 mg twice daily (1440 mg/day).
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patient and Allograft Survival 12 Months | Patient and allograft survival at 12 months post-transplant. Allograft survival is different from rejection. An allograft can have rejection, but the allograft can still have survival. If an allograft fails and is no longer functioning this would be considered allograft failure and non-survival. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Renal Function at 12 Months | Renal function measured by serum creatinine (SCr) at 12 months post-transplant | Posted | Mean | Standard Deviation | mg/dL | 12 months |
|
|
|
| Secondary | Incidence of Post Transplant Infections | Incidence of post transplant infections that resulted in hospitalization | Posted | Number | participants | 12 months |
|
|
|
| Secondary | GI Toxicities | Hospitalizations due to Gastrointestinal (GI) toxicities of mycophenolic acid enteric coated (Myfortic) | Posted | Number | participants | 12 months |
|
|
|
| 4 |
| 22 |
| 17 |
| 22 |
| EG001 | Mycophenolic Acid No Load Group | Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day) | 14 | 23 | 15 | 23 |
| Chest Pain | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Creatinine Increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Acute Tubular Necrosis | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Acute Kidney Failure | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hemorrhoidal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Worsening Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dehiscence with evisceration | Surgical and medical procedures | CTCAE (4.0) | Non-systematic Assessment |
|
| Coronary Artery Bypass | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Wound Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Altered Mental Status | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Post-transplant lymphoproliferative disorder (PTLD) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment |
|
| Wound dehiscence | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| CMV Viremia | Immune system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |