Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Conversion to a sirolimus-based regimen |
|
| 2 | Active Comparator | Continuation of a CNI-based regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sirolimus | Drug |
| ||
| cyclosporine or tacrolimus |
| Measure | Description | Time Frame |
|---|---|---|
| New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year | The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Biopsy Confirmed New NMSC Lesion. | The time to first biopsy confirmed new NMSC lesion starts at 1 day post randomization to biopsy and/or treatment of newly confirmed NMSC lesion. | up to 24 months |
| Number of Lesion Free Subjects |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Canada, clintrialparticipation@wyeth.com | Principal Investigator |
| Trial Manager | For Australia, medinfo@wyeth.com | Principal Investigator |
| Trial Manager | For New Zealand, medinfo@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | 92103 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22420843 | Derived | Campbell SB, Walker R, Tai SS, Jiang Q, Russ GR. Randomized controlled trial of sirolimus for renal transplant recipients at high risk for nonmelanoma skin cancer. Am J Transplant. 2012 May;12(5):1146-56. doi: 10.1111/j.1600-6143.2012.04004.x. Epub 2012 Mar 15. |
Not provided
Not provided
Screening and baseline evaluations were performed within 4 weeks prior to randomization. Randomization assignments by site were stratified by the number of new NMSC lesions in the 12 months prior to enrollment (0-5 lesions vs 6-20 lesions).
Subjects were recruited in Australia, New Zealand and North America from August 2005 (first subject randomized September 2005) through October 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sirolimus (SRL) Based Regimen | All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The overall number of subjects who were lesion free were compared between treatment groups with the Cochran Mantel Haenszel test stratified by baseline NMSC stratum. Within each stratum, the Fisher exact test was used to compare the proportions of lesion free subjects between treatment groups.
| up to 24 months |
| Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) | up to 24 months |
| Grade Distribution of NMSC Lesions | Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC). | up to 24 months |
| Number of Recurrent NMSC Lesions Per Subject-year | Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion. | up to 24 months |
| Subjects Reporting Incidence of Metastatic Disease Related to NMSC. | The number of subjects with metastatic disease related to NMSC. | up to 24 months |
| Death Due to NMSC | up to 24 months |
| Number of Subjects Who Discontinue Assigned Therapy | up to 24 months |
| Nankivell-Calculated Glomerular Filtration Rate (GFR) | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using Nankivell. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure. | At 24 months (week 104) |
| Serum Creatinine Level | Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatinine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly patients typically have smaller muscle mass. | At 24 months (Week 104) |
| Number of Participants That Died | up to 24 months |
| Graft Survival Measured by Graft Loss | Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 consecutive weeks), retransplant, or death. | up to 24 months |
| Number of Subjects With Biopsy-Confirmed Acute Rejection | up to 24 months |
| Spot Urine Protein:Creatinine Ratio | Subjects' urine protein:creatinine ratios were summarized by each scheduled visit, and the nonparametric Wilcoxon rank sum test was used to compare the difference between groups. | At 24 months (Week 104) |
| San Francisco |
| California |
| 94143 |
| United States |
| Gainesville | Florida | 32610 | United States |
| Atlanta | Georgia | 30309 | United States |
| Chicago | Illinois | 60612 | United States |
| Durham | North Carolina | 27710 | United States |
| Cincinnati | Ohio | 45267 | United States |
| Portland | Oregon | 97239 | United States |
| Philadelphia | Pennsylvania | 19102 | United States |
| Charleston | South Carolina | 29425 | United States |
| Nashville | Tennessee | 37232 | United States |
| Madison | Wisconsin | 53792 | United States |
| Camperdown | New South Wales | 2050 | Australia |
| Wooloongabba | Queensland | 4102 | Australia |
| Woodville | South Australia | 5011 | Australia |
| Adelaide | SA 5000 | Australia |
| Clayton | VIC 3169 | Australia |
| Herston | QLD 4029 | Australia |
| Parkville | VIC 3050 | Australia |
| Randwick | NSW 2031 | Australia |
| Westmead | NSW 2145 | Australia |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Grafton | Auckland | 1031 | New Zealand |
| FG001 | Calcineurin Inhibitor (CNI) Based Regimen | Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sirolimus (SRL) Based Regimen | All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted. |
| BG001 | Calcineurin Inhibitor (CNI) Based Regimen | Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Stratification Group | Number | subjects |
| ||||||||||||||||
| Time from Current Transplantation to Randomization | Mean | Standard Deviation | Months |
|
| 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 | New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year | The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study. | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | Standardized Yearly Rate of NMSC | up to 24 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Biopsy Confirmed New NMSC Lesion. | The time to first biopsy confirmed new NMSC lesion starts at 1 day post randomization to biopsy and/or treatment of newly confirmed NMSC lesion. | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Median | 95% Confidence Interval | number of days | up to 24 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Lesion Free Subjects | The overall number of subjects who were lesion free were compared between treatment groups with the Cochran Mantel Haenszel test stratified by baseline NMSC stratum. Within each stratum, the Fisher exact test was used to compare the proportions of lesion free subjects between treatment groups. | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | participants | up to 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | Percentage of Participants | up to 24 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Grade Distribution of NMSC Lesions | Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC). | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | participants | up to 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Recurrent NMSC Lesions Per Subject-year | Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion. | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | lesions per participant year | up to 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Subjects Reporting Incidence of Metastatic Disease Related to NMSC. | The number of subjects with metastatic disease related to NMSC. | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | participants | up to 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Death Due to NMSC | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | participants | up to 24 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Who Discontinue Assigned Therapy | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | participants | up to 24 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Nankivell-Calculated Glomerular Filtration Rate (GFR) | GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using Nankivell. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure. | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. For the intention to treat analysis, a GFR of 0 was imputed for graft loss or death, and last observation carried forward (LOCF) for missing values. | Posted | Jan 2010 | Mean | Standard Deviation | units on scale | At 24 months (week 104) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Creatinine Level | Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatinine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly patients typically have smaller muscle mass. | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. All available data, no imputations. | Posted | Jan 2010 | Mean | Standard Deviation | μmol/L | At 24 months (Week 104) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants That Died | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | participants | up to 24 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Graft Survival Measured by Graft Loss | Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 consecutive weeks), retransplant, or death. | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | graft loss | up to 24 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Biopsy-Confirmed Acute Rejection | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. | Posted | Jan 2010 | Number | subjects | up to 24 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Spot Urine Protein:Creatinine Ratio | Subjects' urine protein:creatinine ratios were summarized by each scheduled visit, and the nonparametric Wilcoxon rank sum test was used to compare the difference between groups. | Intention to Treat: All randomly assigned subjects with at least 1 dose of study medication, includes data of subjects on therapy, those off therapy, and those who completed follow-up. Available data, no imputations. | Posted | Jan 2010 | Median | Full Range | ratio (mg/mg) | At 24 months (Week 104) |
|
Not provided
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 | Sirolimus (SRL) Based Regimen | All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted. | 15 | 39 | 38 | 39 | ||
| EG001 | Calcineurin Inhibitor (CNI) Based Regimen | Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. | 21 | 47 | 40 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | General disorders | Non-systematic Assessment |
| ||
| Cellulitis | General disorders | Non-systematic Assessment |
| ||
| Neoplasm | General disorders | Non-systematic Assessment |
| ||
| Sepsis | General disorders | Non-systematic Assessment |
| ||
| Transplant rejection | General disorders | Non-systematic Assessment |
| ||
| Aneurysm | Cardiac disorders | Non-systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Arterial anomaly | Cardiac disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Left heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial infarct | Cardiac disorders | Non-systematic Assessment |
| ||
| Thrombosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Rectal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Lymphoma | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Creatinine increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Confusion | Nervous system disorders | Non-systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Subdural hematoma | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleural effusion | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin melanoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Acute kidney failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Kidney failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Prostatic carcinoma | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Pyelonephritis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | Non-systematic Assessment |
| ||
| Accidental Injury | General disorders | Non-systematic Assessment |
| ||
| Adenoma | General disorders | Non-systematic Assessment |
| ||
| Allergic reaction | General disorders | Non-systematic Assessment |
| ||
| Asthenia | General disorders | Non-systematic Assessment |
| ||
| Back pain | General disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Cyst | General disorders | Non-systematic Assessment |
| ||
| Drug level decreased | General disorders | Non-systematic Assessment |
| ||
| Drug level increased | General disorders | Non-systematic Assessment |
| ||
| Face edema | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Flu syndrome | General disorders | Non-systematic Assessment |
| ||
| Headache | General disorders | Non-systematic Assessment |
| ||
| Hernia | General disorders | Non-systematic Assessment |
| ||
| Hormone level altered | General disorders | Non-systematic Assessment |
| ||
| Infection | General disorders | Non-systematic Assessment |
| ||
| Lab test abnormal | General disorders | Non-systematic Assessment |
| ||
| Malaise | General disorders | Non-systematic Assessment |
| ||
| Neck pain | General disorders | Non-systematic Assessment |
| ||
| Neoplasm | General disorders | Non-systematic Assessment |
| ||
| Pain | General disorders | Non-systematic Assessment |
| ||
| Pelvic pain | General disorders | Non-systematic Assessment |
| ||
| Tolerance decreased | General disorders | Non-systematic Assessment |
| ||
| Transplant rejection | General disorders | Non-systematic Assessment |
| ||
| Aneurysm | Cardiac disorders | Non-systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Non-systematic Assessment |
| ||
| Arterial anomaly | Cardiac disorders | Non-systematic Assessment |
| ||
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiomegaly | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiovascular physical finding | Cardiac disorders | Non-systematic Assessment |
| ||
| Cyanosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Deep vein thrombosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Hemorrhage | Cardiac disorders | Non-systematic Assessment |
| ||
| Hypertension | Cardiac disorders | Non-systematic Assessment |
| ||
| Hypotension | Cardiac disorders | Non-systematic Assessment |
| ||
| Left heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial infarct | Cardiac disorders | Non-systematic Assessment |
| ||
| Peripheral vascular disorder | Cardiac disorders | Non-systematic Assessment |
| ||
| Retinal artery occlusion | Cardiac disorders | Non-systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Thrombophlebitis superficial | Cardiac disorders | Non-systematic Assessment |
| ||
| Thrombosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Anorexia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cholecystitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Duodenal ulcer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fecal incontinence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Liver fatty deposit | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Liver function tests abnormal | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mouth ulceration | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Rectal disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Rectal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Tongue discoloration | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Thyroid disorder | Endocrine disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Antinuclear antibody present | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Ecchymosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Lymphocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Avitaminosis | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Creatinine increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Edema | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Glucose tolerance decreased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypercholesteremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperlipemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Lactic dehydrogenase increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Peripheral edema | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Sgpt increased | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Thirst | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Weight loss | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Bone disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Joint disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Myopathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Osteopenia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Synovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Depression | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dizziness postural | Nervous system disorders | Non-systematic Assessment |
| ||
| Emotional lability | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Nervous system disorders | Non-systematic Assessment |
| ||
| Nervousness | Nervous system disorders | Non-systematic Assessment |
| ||
| Neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Sleep disorder | Nervous system disorders | Non-systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Non-systematic Assessment |
| ||
| Subdural hematoma | Nervous system disorders | Non-systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough increased | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Laryngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Lung infiltration nos | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Folliculitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Fungal dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Herpes simplex | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Herpes zoster | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Maculopapular rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pruritic rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pustular rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Seborrheic keratosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin carcinoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin hypertrophy | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Abnormal vision | Eye disorders | Non-systematic Assessment |
| ||
| Cataract specified | Eye disorders | Non-systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
| ||
| Dry eyes | Eye disorders | Non-systematic Assessment |
| ||
| Ear disorder | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Eye disorder | Eye disorders | Non-systematic Assessment |
| ||
| Eye hemorrhage | Eye disorders | Non-systematic Assessment |
| ||
| Otitis media | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Retinal disorder | Eye disorders | Non-systematic Assessment |
| ||
| Retinal edema | Eye disorders | Non-systematic Assessment |
| ||
| Taste perversion | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Acute kidney failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Albuminuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Breast disorder | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Breast pain | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hydroureter | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Kidney function abnormal | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Prostatic specific antigen increase | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Testis disorder | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urogenital disorder | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Allergic reaction other than drug | General disorders | Non-systematic Assessment |
| ||
| Device malfunction | General disorders | Non-systematic Assessment |
| ||
| Local reaction to procedure | General disorders | Non-systematic Assessment |
|
A blinded review of data in May 2007 determined there was minimal added power in follow-up through 2 years vs. 1 year. The study was then amended to require at least 1 year of follow-up instead of 2 years.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| 6-20 Lesions in 12 months prior |
|
Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. |
|
|
|
| Calcineurin Inhibitor (CNI) Based Regimen |
Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. |
|
|
|
|
|
|
Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
|
|
|
Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
|
|
|
Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
|
|
|
|
|
|
|
| OG001 | Calcineurin Inhibitor (CNI) Based Regimen | Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. |
|
|
|
| OG001 | Calcineurin Inhibitor (CNI) Based Regimen | Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. |
|
|
|
|
|
|
Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. |
|
|
|
|
|
|
Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated. |
|
|
|