Atherosclerosis, Kidney Failure
Conditions
Keywords
Kidney transplant, Renal transplant, Immunosuppression, Atherosclerosis, Graft Rejection
Brief summary
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of atherosclerosis in renal transplant recipients.
Detailed description
A decision to terminate the study was taken in November 2011 and a communication to that effect sent to all participating sites on November 18. All sites were asked to have patients returned to the sites and have all end of study procedures performed by Dec 31, 2011. The decision to terminate this study was made following the conduct of an interim analysis which demonstrated that the study did not reach its primary endpoint. The termination of this study was not driven by any safety concerns and had no impact on subject safety and well-being.
Interventions
DRUGtacrolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol TAC should be initiated within 24 hours before or after transplantation or within 14 days of transplantation as per local standard of care and tapered to a target trough level of 3-10 ng/mL by the Pre-Conversion visit at month 3-4 post-transplantation. The target trough level of TAC will be maintained at 3-10 ng/mL through to the end of the study.
DRUGmycophenolate mofetil
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol MMF or MPS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum oral dose of MMF ≥ 500 mg/day or MPS ≥ 360 mg/day by the Pre-Conversion visit at month 3-4 post-transplantation. At the discretion of the investigator, MMF may be changed to MPS, or MPS may be changed to MMF. MMF is to be continued at ≥ 500 mg/day dose or MPS is to be continued at ≥ 360 mg/day dose through to the end of study.
DRUGprednisone
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol CCS should be initiated within 24 hours before or after transplantation or within 14 days of transplantation per local standard of care and tapered to a minimum of 5 mg/day of prednisone orally or the alternate day equivalent by the Pre-Conversion visit at month 3-4 post-transplant. Continue administration of prednisone as per local standard of care to a minimum dose of 2.5 mg/day or alternate day equivalent dose to the end of the study. Withdrawal of CCS is prohibited.
DRUGsirolimus
The daily dosage and formulation for each study treatment will be chosen by the investigator as medically appropriate for each individual subject, in order to achieve the target levels specified in the protocol. On study Day 1 Conversion, the daily dose of TAC will not be taken, and SRL is initiated as a single 5-10 mg loading dose, followed by 3 mg/day on subsequent days, adjusted to maintain a SRL target trough level of 8-15 ng/mL through to month 24 post-transplant, then 5-12 ng/mL to the end of month 36 post-transplant.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
At least one of the following characteristics: * History of dialysis for at least 3 years. * History of diabetes for at least 5 years. * Hypertension or ischemic nephropathy as a cause of the end stage renal disease or loss of the first transplant. * History of coronary artery disease, stroke, myocardial infarction, or amputation for vascular disease.
Exclusion criteria
* History of malignancy within the last 5 years (except adequately treated skin cancer). * Recipients of non-renal organ transplant. * Active gastrointestinal disease that may interfere with drug absorption. * Active HIV, hepatitis B or C infection. * Women who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant | Pre-conversion baseline and 12 months post-transplant | Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus \[-\] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries. |
| TPV at Pre-conversion Baseline | Pre-conversion baseline | TPV is the sum of the assessment in left and right distal common carotid arteries. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CIMT at Pre-conversion Baseline | Pre-conversion baseline | Mean CIMT=average of left CIMT and right CIMT. |
| Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant | Pre-conversion baseline, 12, and 24 months post-transplant | Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline. |
| Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant | Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline. |
| Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values. |
| Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline. |
| Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | HbA1C, change = value at month x post-transplant - pre-conversion baseline. |
| Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values. |
| Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. | Pre-conversion baseline, 12, 24 and 36 months post-transplant | hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. |
| Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. |
| Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. |
| Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values. |
| Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. |
| Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. |
| Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. |
| Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values. |
| Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values. |
| Number of Participants Who Used Lipid Lowering Therapies | From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant | Participants who reported yes for taking lipid lowering therapies as concomitant medication. |
| Number of Participants Who Used Anti-hypertensive Medications | From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant | Participants who reported yes for taking anti-hypertensive medications as concomitant medication. |
| Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant | Pre-conversion baseline, and 18, 24 and 36 months post-transplant | Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus \[-\] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries. |
| Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant | Pre-conversion baseline, 12, 24 and 36 months post-transplant | Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values. |
| Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant | Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant | Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (\>=500 mg/day) or mycophenolate sodium (MPS) (\>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study. | 37 |
| Tacrolimus With Mycophenolate/Prednisone Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (\>=500 mg/day) or MPS (\>=360 mg/day) or AZA (\>=50 mg/day) plus prednisone (\>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration \[C0\] level 50-250 ng/mL; target CsA concentration 2 hours post-dose \[C2\] level 200-1200 ng/mL) at the discretion of the investigator. | 35 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of ancillary assistance | 0 | 1 |
| Overall Study | Noncompliance | 0 | 1 |
| Overall Study | Study Termination by Sponsor | 3 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Tacrolimus With Mycophenolate/Prednisone | Total |
|---|---|---|---|
| Age Continuous | 55.8 years STANDARD_DEVIATION 11.11 | 55.5 years STANDARD_DEVIATION 11.08 | 55.7 years STANDARD_DEVIATION 11.02 |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 26 Participants | 26 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 36 / 37 | 33 / 35 |
| serious Total, serious adverse events | 17 / 37 | 21 / 35 |
Outcome results
Primary
Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 12 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 12 post-transplant minus \[-\] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
Time frame: Pre-conversion baseline and 12 months post-transplant
Population: On-Therapy Population: includes all intent-to-treat (ITT) subjects who also remained on assigned therapy until 12 months post-transplant for the primary endpoint, or until 36 months post-transplant for the cardiovascular and safety endpoints; N=number of evaluable participants for the outcome measure at 12 months post-transplant
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant | -49.31 millimeter cube/year (mmˆ3/year) | Standard Deviation 125.038 |
| Tacrolimus With Mycophenolate/Prednisone | Annual Change Rate in Total Plaque Volume (TPV) From Pre-conversion Baseline to 12 Months Post-transplant | 0.66 millimeter cube/year (mmˆ3/year) | Standard Deviation 23.103 |
Primary
TPV at Pre-conversion Baseline
TPV is the sum of the assessment in left and right distal common carotid arteries.
Time frame: Pre-conversion baseline
Population: On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | TPV at Pre-conversion Baseline | 68.68 mmˆ3 | Standard Deviation 116.574 |
| Tacrolimus With Mycophenolate/Prednisone | TPV at Pre-conversion Baseline | 48.57 mmˆ3 | Standard Deviation 72.207 |
Secondary
Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant
Within-subject annual change rate in CIMT as determined by ultrasound. Mean CIMT=average of left CIMT and right CIMT. Annual CIMT Change Rate (mm/year) = (CIMT at Month x Post-transplant Visit - CIMT at Conversion Baseline) / Imaging interval in years.
Time frame: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant | Annual Change Rate at 12 months (n=16,28) | 0.048 millimeter/year (mm/year) | Standard Deviation 0.0977 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant | Annual Change Rate at 18 months (n=15,26) | 0.041 millimeter/year (mm/year) | Standard Deviation 0.0641 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant | Annual Change Rate at 24 months (n=15,23) | 0.023 millimeter/year (mm/year) | Standard Deviation 0.0614 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant | Annual Change Rate at 36 months (n=8,13) | 0.028 millimeter/year (mm/year) | Standard Deviation 0.0381 |
| Tacrolimus With Mycophenolate/Prednisone | Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant | Annual Change Rate at 36 months (n=8,13) | -0.007 millimeter/year (mm/year) | Standard Deviation 0.046 |
| Tacrolimus With Mycophenolate/Prednisone | Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant | Annual Change Rate at 12 months (n=16,28) | 0.012 millimeter/year (mm/year) | Standard Deviation 0.0732 |
| Tacrolimus With Mycophenolate/Prednisone | Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant | Annual Change Rate at 24 months (n=15,23) | 0.015 millimeter/year (mm/year) | Standard Deviation 0.0453 |
| Tacrolimus With Mycophenolate/Prednisone | Annual Change Rate in Carotid Intima Media Thickness (CIMT) From Pre-conversion Baseline at 12, 18, 24 and 36 Months Post-transplant | Annual Change Rate at 18 months (n=15,26) | -0.0002 millimeter/year (mm/year) | Standard Deviation 0.0543 |
Comparison: 12 months post-transplantp-value: 0.044595% CI: [0.001, 0.07]ANCOVA
Comparison: 18 months post-transplantp-value: 0.028895% CI: [0.004, 0.064]ANCOVA
Comparison: 24 months post-transplantp-value: 0.026995% CI: [0.004, 0.06]ANCOVA
Comparison: 36 months post-transplantp-value: 0.09795% CI: [-0.005, 0.06]ANCOVA
Secondary
Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant
Within-subject annual change rate in TPV in the left and right distal common carotid arteries from the pre-conversion baseline to 18, 24 and 36 months post kidney transplant as determined by ultrasound. Annual change rate equals (=) (TPV at month 18, 24 and 36 post-transplant minus \[-\] TPV at pre-conversion baseline) divided (/) by imaging interval in years. TPV is the sum of assessment in left and right distal common carotid arteries.
Time frame: Pre-conversion baseline, and 18, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant | Month 18 post-transplant (n=12,12) | 17.15 mmˆ3/year | Standard Deviation 92.151 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant | Month 24 post-transplant (n=11,14) | 25.28 mmˆ3/year | Standard Deviation 67.393 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant | Month 36 post-transplant (n=7,11) | 6.62 mmˆ3/year | Standard Deviation 66.24 |
| Tacrolimus With Mycophenolate/Prednisone | Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant | Month 18 post-transplant (n=12,12) | 19.71 mmˆ3/year | Standard Deviation 44.734 |
| Tacrolimus With Mycophenolate/Prednisone | Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant | Month 24 post-transplant (n=11,14) | 9.10 mmˆ3/year | Standard Deviation 39.707 |
| Tacrolimus With Mycophenolate/Prednisone | Annual Rate of Change in TPV From Pre-conversion Baseline to 18, 24 and 36 Months Post Transplant | Month 36 post-transplant (n=7,11) | 8.98 mmˆ3/year | Standard Deviation 25.505 |
Comparison: 18 months post-transplantp-value: 0.271895% CI: [-50.7, 14.7]ANCOVA
Comparison: 24 months post-transplantp-value: 0.272995% CI: [-41.6, 12.1]ANCOVA
Comparison: 36 months post-transplantp-value: 0.290295% CI: [-23.8, 7.3]ANCOVA
Secondary
Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant
Adiponectin is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates less risk. Change = month x post-transplant values - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,33) | 5.352 microgram per milliliter (µg/mL) | Standard Deviation 5.8935 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,31) | 2.244 microgram per milliliter (µg/mL) | Standard Deviation 7.3628 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | 1.487 microgram per milliliter (µg/mL) | Standard Deviation 6.0933 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,33) | -2.205 microgram per milliliter (µg/mL) | Standard Deviation 8.2503 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,31) | -0.267 microgram per milliliter (µg/mL) | Standard Deviation 6.6144 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Adiponectin at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | -1.413 microgram per milliliter (µg/mL) | Standard Deviation 8.8053 |
Comparison: 12 months post-transplantp-value: 0.001695% CI: [2.2, 8.93]ANCOVA
Comparison: 24 months post-transplantp-value: 0.009195% CI: [1.01, 6.8]ANCOVA
Comparison: 36 months post-transplantp-value: 0.246895% CI: [-1.6, 6.1]ANCOVA
Secondary
Change From Pre-conversion Baseline in Carotid Plaque Roughness at 12 and 24 Months Post-transplant
Carotid plaque roughness as determined by ultrasound. Change equals (=) value at post-transplant month x minus (-) pre-conversion baseline.
Time frame: Pre-conversion baseline, 12, and 24 months post-transplant
Population: Evaluation of carotid plaque roughness at pre-conversion baseline, and at 12 and 24 months post-transplant was planned in the study design, however during the study conduct, it was removed as a cardiovascular endpoint since it was not validated.
Secondary
Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant
Endothelin-1 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=22,30) | 0.294 pg/mL | Standard Deviation 0.4975 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,30) | 0.426 pg/mL | Standard Deviation 0.5376 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=14,22) | 0.411 pg/mL | Standard Deviation 0.7316 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=22,30) | 0.028 pg/mL | Standard Deviation 0.402 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,30) | 0.138 pg/mL | Standard Deviation 0.8367 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Endothelin-1 at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=14,22) | -0.104 pg/mL | Standard Deviation 0.7767 |
Comparison: 12 months post-transplantp-value: 0.02895% CI: [0.03, 0.48]ANCOVA
Comparison: 24 months post-transplantp-value: 0.01995% CI: [0.04, 0.48]ANCOVA
Comparison: 36 months post-transplantp-value: 0.118295% CI: [-0.07, 0.6]ANCOVA
Secondary
Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant
Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL) and Triglyceride (Tg) blood concentrations. Higher levels of TC, LDL and Tg are less desirable. Lower levels of HDL are less desirable. Change for each parameter = value at 12, 18, 24 and 36 months post-transplant - value at pre-conversion baseline.
Time frame: Pre-conversion baseline, and 12, 18, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in TC 12 Months post-transplant (n=23,30) | 0.510 millimole/liter (mmol/L) | Standard Deviation 1.0743 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in LDL 12 Months post-transplant (n=21,30) | 0.277 millimole/liter (mmol/L) | Standard Deviation 0.8282 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in HDL 12 Months post-transplant (n=23,30) | 0.059 millimole/liter (mmol/L) | Standard Deviation 0.3009 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in Tg 12 Months post-transplant (n=23,30) | 0.617 millimole/liter (mmol/L) | Standard Deviation 1.1135 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in TC 18 Months post-transplant (n=21,29) | 0.361 millimole/liter (mmol/L) | Standard Deviation 1.0704 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in LDL 18 Months post-transplant (n=20,29) | 0.222 millimole/liter (mmol/L) | Standard Deviation 0.9283 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in HDL 18 Months post-transplant (n=21,29) | 0.106 millimole/liter (mmol/L) | Standard Deviation 0.2824 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in Tg 18 Months post-transplant (n=21,29) | 0.359 millimole/liter (mmol/L) | Standard Deviation 0.9941 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in TC 24 Months post-transplant (n=19,27) | 0.240 millimole/liter (mmol/L) | Standard Deviation 1.1375 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in LDL 24 Months post-transplant (n=16,27) | 0.067 millimole/liter (mmol/L) | Standard Deviation 0.9493 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in HDL 24 Months post-transplant (n=19,27) | 0.067 millimole/liter (mmol/L) | Standard Deviation 0.2485 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in Tg 24 Months post-transplant (n=19,27) | 0.547 millimole/liter (mmol/L) | Standard Deviation 1.4083 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in TC 36 Months post-transplant (n=15,21) | 0.386 millimole/liter (mmol/L) | Standard Deviation 0.4841 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in LDL 36 Months post-transplant (n=13,21) | 0.027 millimole/liter (mmol/L) | Standard Deviation 0.5619 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in HDL 36 Months post-transplant (n=15,21) | 0.098 millimole/liter (mmol/L) | Standard Deviation 0.2141 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in Tg 36 Months post-transplant (n=15,21) | 0.527 millimole/liter (mmol/L) | Standard Deviation 0.9968 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in Tg 36 Months post-transplant (n=15,21) | -0.385 millimole/liter (mmol/L) | Standard Deviation 0.7824 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in TC 12 Months post-transplant (n=23,30) | -0.164 millimole/liter (mmol/L) | Standard Deviation 0.8271 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in TC 24 Months post-transplant (n=19,27) | -0.008 millimole/liter (mmol/L) | Standard Deviation 1.0813 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in LDL 12 Months post-transplant (n=21,30) | -0.056 millimole/liter (mmol/L) | Standard Deviation 0.5612 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in TC 36 Months post-transplant (n=15,21) | -0.323 millimole/liter (mmol/L) | Standard Deviation 1.0652 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in HDL 12 Months post-transplant (n=23,30) | -0.053 millimole/liter (mmol/L) | Standard Deviation 0.4417 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in LDL 24 Months post-transplant (n=16,27) | 0.054 millimole/liter (mmol/L) | Standard Deviation 0.825 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in Tg 12 Months post-transplant (n=23,30) | -0.117 millimole/liter (mmol/L) | Standard Deviation 0.6088 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in HDL 36 Months post-transplant (n=15,21) | 0.111 millimole/liter (mmol/L) | Standard Deviation 0.3042 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in TC 18 Months post-transplant (n=21,29) | 0.082 millimole/liter (mmol/L) | Standard Deviation 1.1427 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in HDL 24 Months post-transplant (n=19,27) | -0.019 millimole/liter (mmol/L) | Standard Deviation 0.3552 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in LDL 18 Months post-transplant (n=20,29) | 0.138 millimole/liter (mmol/L) | Standard Deviation 0.86 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in LDL 36 Months post-transplant (n=13,21) | -0.257 millimole/liter (mmol/L) | Standard Deviation 0.8248 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in HDL 18 Months post-transplant (n=21,29) | -0.030 millimole/liter (mmol/L) | Standard Deviation 0.3601 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in Tg 24 Months post-transplant (n=19,27) | -0.088 millimole/liter (mmol/L) | Standard Deviation 0.8131 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fasting Lipid Parameters at 12, 18, 24 and 36 Months Post-transplant | Change in Tg 18 Months post-transplant (n=21,29) | -0.057 millimole/liter (mmol/L) | Standard Deviation 0.8699 |
Comparison: LDL 24 Months Post-transplantp-value: 0.084595% CI: [-0.04, 0.6]ANCOVA
Comparison: TC 12 Months Post-transplantp-value: <0.000195% CI: [0.39, 1.09]ANCOVA
Comparison: LDL 12 Months Post-transplantp-value: 0.002295% CI: [0.15, 0.67]ANCOVA
Comparison: HDL 12 Months Post-transplantp-value: 0.161295% CI: [-0.03, 0.19]ANCOVA
Comparison: Tg 12 Months Post-transplantp-value: 0.000595% CI: [0.26, 0.86]ANCOVA
Comparison: TC 18 Months Post-transplantp-value: 0.000695% CI: [0.3, 1.02]ANCOVA
Comparison: LDL 18 Months Post-transplantp-value: 0.012695% CI: [0.08, 0.61]ANCOVA
Comparison: HDL 18 Months Post-transplantp-value: 0.23895% CI: [-0.04, 0.17]ANCOVA
Comparison: Tg 18 Months Post-transplantp-value: 0.000395% CI: [0.27, 0.88]ANCOVA
Comparison: TC 24 Months Post-transplantp-value: 0.006595% CI: [0.17, 1]ANCOVA
Comparison: HDL 24 Months Post-transplantp-value: 0.374295% CI: [-0.06, 0.16]ANCOVA
Comparison: Tg 24 Months Post-transplantp-value: 0.000695% CI: [0.27, 0.92]ANCOVA
Comparison: TC 36 Months Post-transplantp-value: 0.148895% CI: [-0.16, 1.03]ANCOVA
Comparison: LDL 36 Months Post-transplantp-value: 0.54695% CI: [-0.33, 0.62]ANCOVA
Comparison: HDL 36 Months Post-transplantp-value: 0.751195% CI: [-0.12, 0.16]ANCOVA
Comparison: Tg 36 Months Post-transplantp-value: 0.004895% CI: [0.2, 1.06]ANCOVA
Secondary
Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant
Fibrinogen is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=22,31) | 0.62 gram per liter (g/L) | Standard Deviation 0.778 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,29) | 0.45 gram per liter (g/L) | Standard Deviation 0.777 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=14,20) | 0.40 gram per liter (g/L) | Standard Deviation 0.557 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=22,31) | 0.20 gram per liter (g/L) | Standard Deviation 0.769 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,29) | 0.33 gram per liter (g/L) | Standard Deviation 0.741 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Fibrinogen at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=14,20) | 0.21 gram per liter (g/L) | Standard Deviation 0.74 |
Comparison: 12 months post-transplantp-value: 0.04195% CI: [0, 0.8]ANCOVA
Comparison: 24 months post-transplantp-value: 0.027595% CI: [0, 0.6]ANCOVA
Comparison: 36 months post-transplantp-value: 0.184195% CI: [-0.1, 0.6]ANCOVA
Secondary
Change From Pre-conversion Baseline in Folate at 12, 24 and 36 Months Post-transplant
Folate is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: Two types of folate tests were used: serum folate and red blood cell (RBC) folate. The tests were not consistent across sites. Therefore, the evaluation was not analyzed.
Secondary
Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant
Fasting plasma glucose. Change = value at month x post-transplant - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,33) | 0.606 mmol/L | Standard Deviation 2.9461 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,31) | 0.832 mmol/L | Standard Deviation 2.2068 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=14,22) | 0.686 mmol/L | Standard Deviation 2.3559 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,33) | -0.083 mmol/L | Standard Deviation 1.7377 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,31) | -0.076 mmol/L | Standard Deviation 2.3982 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glucose at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=14,22) | -0.214 mmol/L | Standard Deviation 1.8239 |
Comparison: 12 months post-transplantp-value: 0.175795% CI: [-0.36, 1.91]ANCOVA
Comparison: 24 months post-transplantp-value: 0.050995% CI: [0, 1.89]ANCOVA
Comparison: 36 months post-transplantp-value: 0.068395% CI: [-0.09, 2.31]ANCOVA
Secondary
Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant
HbA1C, change = value at month x post-transplant - pre-conversion baseline.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at the specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant | Change at 12 Months post-transplant (n=23,26) | 0.008 percentage of glucose | Standard Deviation 0.0176 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant | Change at 24 Months post-transplant (n=17,25) | 0.009 percentage of glucose | Standard Deviation 0.0161 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant | Change at 36 Months post-transplant (n=14,16) | 0.012 percentage of glucose | Standard Deviation 0.0208 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant | Change at 12 Months post-transplant (n=23,26) | 0.001 percentage of glucose | Standard Deviation 0.0175 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant | Change at 24 Months post-transplant (n=17,25) | 0.006 percentage of glucose | Standard Deviation 0.02 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Glycosylated Hemoglobin(HbA1C) at Months 12, 24, and 36 Post-transplant | Change at 36 Months post-transplant (n=14,16) | -0.001 percentage of glucose | Standard Deviation 0.0232 |
Comparison: 12 months post-transplantp-value: 0.489295% CI: [-0.005, 0.011]ANCOVA
Comparison: 24 months post-transplantp-value: 0.051495% CI: [0, 0.012]ANCOVA
Comparison: 36 months post-transplantp-value: 0.11895% CI: [-0.002, 0.02]ANCOVA
Secondary
Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant.
hsCRP is a biomarker of cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. | Change at 12 Months post-transplant (n=23,33) | 1.611 mg/L | Standard Deviation 9.7219 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. | Change at 24 Months post-transplant (n=18,31) | -0.563 mg/L | Standard Deviation 4.8347 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. | Change at 36 Months post-transplant (n=15,22) | 0.336 mg/L | Standard Deviation 11.3537 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. | Change at 12 Months post-transplant (n=23,33) | 1.379 mg/L | Standard Deviation 6.768 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. | Change at 24 Months post-transplant (n=18,31) | 1.723 mg/L | Standard Deviation 7.6259 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Months 12, 24 and 36 Post-transplant. | Change at 36 Months post-transplant (n=15,22) | 3.164 mg/L | Standard Deviation 12.566 |
Comparison: 12 months post-transplantp-value: 0.528295% CI: [-2.05, 3.94]ANCOVA
Comparison: 24 months post-transplantp-value: 0.505795% CI: [-2.53, 5.07]ANCOVA
Comparison: 36 months post-transplantp-value: 0.570195% CI: [-4, 7.18]ANCOVA
Secondary
Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant
Homocysteine is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,33) | 1.278 micromole/liter (µmol/L) | Standard Deviation 3.5572 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,31) | 1.316 micromole/liter (µmol/L) | Standard Deviation 4.5373 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | 1.087 micromole/liter (µmol/L) | Standard Deviation 4.6641 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,33) | 0.530 micromole/liter (µmol/L) | Standard Deviation 4.6244 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,31) | 2.158 micromole/liter (µmol/L) | Standard Deviation 5.8978 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Homocysteine at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | 2.459 micromole/liter (µmol/L) | Standard Deviation 5.3116 |
Comparison: 12 months post-transplantp-value: 0.590295% CI: [-1.63, 2.84]ANCOVA
Comparison: 24 months post-transplantp-value: 0.753695% CI: [-2.68, 1.95]ANCOVA
Comparison: 36 months post-transplantp-value: 0.406695% CI: [-4.53, 1.86]ANCOVA
Secondary
Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant
Fasting insulin. Change = value at month x post-transplant - pre-conversion baseline.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant | Change at 12 Months post-transplant (n=16,23) | -4.549 picomole/liter (pmol/L) | Standard Deviation 69.2139 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant | Change at 24 Months post-transplant (n=13,23) | -6.120 picomole/liter (pmol/L) | Standard Deviation 124.55 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant | Change at 36 Months post-transplant (n=10,14) | -22.759 picomole/liter (pmol/L) | Standard Deviation 79.8717 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant | Change at 12 Months post-transplant (n=16,23) | 17.953 picomole/liter (pmol/L) | Standard Deviation 151.0513 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant | Change at 24 Months post-transplant (n=13,23) | 32.180 picomole/liter (pmol/L) | Standard Deviation 168.4674 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Insulin at Months 12, 24, and 36 Post-transplant | Change at 36 Months post-transplant (n=10,14) | -2.731 picomole/liter (pmol/L) | Standard Deviation 37.6576 |
Comparison: 12 months post-transplantp-value: 0.274195% CI: [-105.79, 30.85]ANCOVA
Comparison: 24 months post-transplantp-value: 0.486595% CI: [-77.48, 37.53]ANCOVA
Comparison: 36 months post-transplantp-value: 0.933995% CI: [-62.54, 57.59]ANCOVA
Secondary
Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant
IL-6 is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,32) | -0.239 pg/mL | Standard Deviation 3.682 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,29) | 0.128 pg/mL | Standard Deviation 6.9315 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | -0.800 pg/mL | Standard Deviation 3.827 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,29) | 0.783 pg/mL | Standard Deviation 4.7295 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,32) | 0.463 pg/mL | Standard Deviation 3.81 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Interleukin-6 (IL-6) at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | 0.164 pg/mL | Standard Deviation 6.4529 |
Comparison: 12 months post-transplantp-value: 0.736195% CI: [-2.09, 1.49]ANCOVA
Comparison: 24 months post-transplantp-value: 0.554995% CI: [-2.32, 1.26]ANCOVA
Comparison: 36 months post-transplantp-value: 0.605895% CI: [-3.69, 2.17]ANCOVA
Secondary
Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant
Lipoprotein(a) is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,30) | 13.496 milligram per deciliter (mg/dL) | Standard Deviation 23.3557 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,26) | 12.517 milligram per deciliter (mg/dL) | Standard Deviation 36.8868 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=13,17) | 11.885 milligram per deciliter (mg/dL) | Standard Deviation 49.4868 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,30) | -11.680 milligram per deciliter (mg/dL) | Standard Deviation 77.1386 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,26) | 6.073 milligram per deciliter (mg/dL) | Standard Deviation 31.5608 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Lipoprotein(a) at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=13,17) | 6.547 milligram per deciliter (mg/dL) | Standard Deviation 22.0615 |
Comparison: 12 months post-transplantp-value: 0.367895% CI: [-11.46, 30.4]ANCOVA
Comparison: 24 months post-transplantp-value: 0.217995% CI: [-6.53, 27.97]ANCOVA
Comparison: 36 months post-transplantp-value: 0.366395% CI: [-14.39, 38.32]ANCOVA
Secondary
Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant
TNF-alpha is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,32) | 0.991 pg/mL | Standard Deviation 6.3462 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,30) | -0.367 pg/mL | Standard Deviation 1.558 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | -0.441 pg/mL | Standard Deviation 1.7067 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,32) | 0.000 pg/mL | Standard Deviation 0 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=18,30) | 1.894 pg/mL | Standard Deviation 10.372 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Tumor Necrosis Factor Alpha (TNF-alpha) at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | 0.000 pg/mL | Standard Deviation 0 |
Secondary
Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant
Uric Acid is a biomarker for cardiovascular disease and atherosclerosis risk. A higher level indicates a greater risk. Change = month x post-transplant values - pre-conversion baseline values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,33) | -51.53 µmol/L | Standard Deviation 68.987 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,31) | -29.02 µmol/L | Standard Deviation 93.35 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | -19.03 µmol/L | Standard Deviation 83.162 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=23,33) | 11.10 µmol/L | Standard Deviation 89.871 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,31) | 3.89 µmol/L | Standard Deviation 85.439 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Uric Acid at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=15,22) | -0.58 µmol/L | Standard Deviation 99.831 |
Comparison: 12 months post-transplantp-value: 0.000295% CI: [-108.6, -36.9]ANCOVA
Comparison: 24 months post-transplantp-value: 0.001795% CI: [-108.5, -26.6]ANCOVA
Comparison: 36 months post-transplantp-value: 0.029395% CI: [-118.2, -6.5]ANCOVA
Secondary
Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant
Vitamin B12 is a biomarker for cardiovascular disease and atherosclerosis risk. A lower level indicates a greater risk. Change = month x post-transplant values - pre-conversion values.
Time frame: Pre-conversion baseline, 12, 24 and 36 months post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable participants at specific time points
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=21,33) | -10.21 pmol/L | Standard Deviation 161.662 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,29) | -36.23 pmol/L | Standard Deviation 88.91 |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=14,21) | -40.00 pmol/L | Standard Deviation 135.353 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant | Change at 12 Months post-transplant (n=21,33) | -11.38 pmol/L | Standard Deviation 146.53 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant | Change at 24 Months post-transplant (n=19,29) | -27.46 pmol/L | Standard Deviation 134.595 |
| Tacrolimus With Mycophenolate/Prednisone | Change From Pre-conversion Baseline in Vitamin B12 at Months 12, 24 and 36 Post-transplant | Change at 36 Months post-transplant (n=14,21) | -46.39 pmol/L | Standard Deviation 183.283 |
Comparison: 12 months post-transplantp-value: 0.079795% CI: [-108.9, 6.3]ANCOVA
Comparison: 24 months post-transplantp-value: 0.234195% CI: [-88.7, 22.2]ANCOVA
Comparison: 36 months post-transplantp-value: 0.685495% CI: [-90.3, 59.8]ANCOVA
Secondary
CIMT at Pre-conversion Baseline
Mean CIMT=average of left CIMT and right CIMT.
Time frame: Pre-conversion baseline
Population: On-Therapy Population; N=number of evaluable participants for the outcome measure at pre-conversion Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | CIMT at Pre-conversion Baseline | 0.735 mm | Standard Deviation 0.1502 |
| Tacrolimus With Mycophenolate/Prednisone | CIMT at Pre-conversion Baseline | 0.773 mm | Standard Deviation 0.1391 |
Secondary
Number of Participants Who Used Anti-hypertensive Medications
Participants who reported yes for taking anti-hypertensive medications as concomitant medication.
Time frame: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Number of Participants Who Used Anti-hypertensive Medications | From consent to conversion | 19 participants |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Number of Participants Who Used Anti-hypertensive Medications | From conversion to Month 12 | 21 participants |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Number of Participants Who Used Anti-hypertensive Medications | From Months 12 to Month 24 | 21 participants |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Number of Participants Who Used Anti-hypertensive Medications | From Months 24 to Month 36 | 18 participants |
| Tacrolimus With Mycophenolate/Prednisone | Number of Participants Who Used Anti-hypertensive Medications | From Months 24 to Month 36 | 28 participants |
| Tacrolimus With Mycophenolate/Prednisone | Number of Participants Who Used Anti-hypertensive Medications | From consent to conversion | 30 participants |
| Tacrolimus With Mycophenolate/Prednisone | Number of Participants Who Used Anti-hypertensive Medications | From Months 12 to Month 24 | 30 participants |
| Tacrolimus With Mycophenolate/Prednisone | Number of Participants Who Used Anti-hypertensive Medications | From conversion to Month 12 | 30 participants |
Comparison: Use Anti-hypertension From Consent to Conversionp-value: 0.4286Fisher Exact
Comparison: Use Anti-hypertension From Conversion to Month 12p-value: 1Fisher Exact
Comparison: Use Anti-hypertension From Month 12 to Month 24p-value: 1Fisher Exact
Comparison: Use Anti-hypertension From Month 24 to Month 36p-value: 1Fisher Exact
Secondary
Number of Participants Who Used Lipid Lowering Therapies
Participants who reported yes for taking lipid lowering therapies as concomitant medication.
Time frame: From consent to conversion, from conversion to Month 12, from Months 12 to 24, and from Months 24 to 36 post-transplant
Population: On-Therapy Population; N=number of evaluable participants; n=number of evaluable at the specific time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Number of Participants Who Used Lipid Lowering Therapies | From consent to conversion | 13 participants |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Number of Participants Who Used Lipid Lowering Therapies | From conversion to Month 12 | 22 participants |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Number of Participants Who Used Lipid Lowering Therapies | From Months 12 to Month 24 | 23 participants |
| Tacrolimus Then Sirolimus With Mycophenolate/Prednisone | Number of Participants Who Used Lipid Lowering Therapies | From Months 24 to Month 36 | 18 participants |
| Tacrolimus With Mycophenolate/Prednisone | Number of Participants Who Used Lipid Lowering Therapies | From Months 24 to Month 36 | 27 participants |
| Tacrolimus With Mycophenolate/Prednisone | Number of Participants Who Used Lipid Lowering Therapies | From consent to conversion | 24 participants |
| Tacrolimus With Mycophenolate/Prednisone | Number of Participants Who Used Lipid Lowering Therapies | From Months 12 to Month 24 | 28 participants |
| Tacrolimus With Mycophenolate/Prednisone | Number of Participants Who Used Lipid Lowering Therapies | From conversion to Month 12 | 29 participants |
Comparison: Use Lipid-Lowering From Consent to Conversionp-value: 0.2573Fisher Exact
Comparison: Use Lipid-Lowering From Conversion to Month 12p-value: 0.6386Fisher Exact
Comparison: Use Lipid-Lowering From Month 12 to Month 24p-value: 0.0709Fisher Exact
Comparison: Use Lipid-Lowering From Month 24 to Month 36p-value: 1Fisher Exact