Immunosuppression, Renal Failure
Conditions
Keywords
Everolimus, Zortress, Renal Function, Tacrolimus, Cyclosporine, Myfortic, Mycophenolic Acid, Liver Transplantation
Brief summary
This study will examine the renal sparing impact of implementing a strategy of conversion to everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post liver transplant
Detailed description
Given the increasing proportion of patients having renal failure at the time of transplant, with the nephrotoxic effect of calcineurin inhibitor based immunosuppression associated with its long term negative survival impact, this study proposes to examine the renal sparing impact of conversion to everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post liver transplant. The 3 month time point was chosen to allow for the switch to everolimus to occur at a period of stable post transplant liver function when both technical and rejection risks are lower. The 3 month cut off was also chosen because of data indicating that worsening renal function at 4 weeks, 3 months and 1 year post transplant is an independent risk factor for the development of chronic renal failure and end stage renal disease after orthotopic liver transplantation. 24 patients will be randomized into 2 arms: Arm A: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant. Arm B: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA). Follow up: 2 years.
Interventions
DRUGArm A: Everolimus
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
Sponsors
Novartis Pharmaceuticals
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Ability and willingness to provide written informed consent and adhere to study regimen. * Primary deceased donor liver transplant recipients 18-70 years of age * Functioning allograft at randomization (AST, ALT, Total Bilirubin levels ≤3 times ULN, and AlkP and GGT levels ≤ 5 times ULN). Elevated GGT alone, in combination with AST, ALT, total bilirubin and AlkP within defined range does not exclude patients from randomization. * Recipients on an immunosuppressive regimen of corticosteroids and tacrolimus. * Confirmed recipient HCV status at Screening (either by serology or PCR). * Abbreviated MDRD eGFR ≥ 30 mL/min/1.73m2. Local and central serum creatinine results within 5 days prior to randomization, however no sooner than Day 25 post-transplantation. * Verification of at least one tacrolimus trough level of ≥ 8 ng/mL one week prior to randomization. Target trough levels above 8 ng/mL prior to randomization. * Patients able to take oral medication at time of randomization.
Exclusion criteria
* Recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant. Combined liver kidney transplant recipients. * Living donor or split liver recipients. * History of malignancy of any organ system within past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC. * Hepatocellular carcinoma that does not fulfill Milan criteria (1 nodule ≤ 5 cm, 2-3 nodules all \< 3 cm, per explant histology of recipient liver. * Use of antibody induction therapy. * Patients with known hypersensitivity to the drugs used on study or their class, or to any of the excipients. * Recipients of ABO incompatible transplant grafts. * Recipients of Hepatitis B surface antigen or HIV donor organs. * Surgical or medical condition, which might significantly alter absorption, distribution, metabolism and excretion of study drug. * Women of child-bearing potential (WOCBP): all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS (1) they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/m, or (2) have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy or (3) are using one or more of the following methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), copper coated IUD and double-barrier methods ( any double combination of male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout and for 3 months after study drug discontinuation. * History of coagulopathy or medical condition requiring long-term anticoagulation which would preclude liver biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed). Enrollment Exclusion - Randomization * Severe hypercholesterolemia (\>350 mg/dL; \>9 mmol/L) or hypertriglyceridemia (\>500 mg/dL; \>8.5 mmol/L) within 6 months of transplantation. Controlled hyperlipidemia is acceptable at time of randomization. * Platelet count \< 50,000/mm3 at randomization. * Absolute neutrophil count \< 1,000/mm³ or white blood cell count \<2,000/mm³ at randomization. * Patients positive for HIV: Negative laboratory results within 6 months before randomization are acceptable. * Clinically significant systemic infection requiring IV antibiotics at randomization. Patients in a critical care setting at randomization requiring life support measures such as mechanical ventilation, dialysis, or vasopressor agents. * Patients on renal replacement therapy within 7 days prior to randomization. * Thrombosis of major hepatic arteries, major hepatic veins, portal vein and inferior vena cava. Results obtained within 5 days prior to randomization are acceptable, however no sooner than Day 25 post-transplantation. * Acute rejection requiring antibody therapy or more than one steroid sensitive episode of acute rejection during the run-in period. Includes patients who have not completed steroid treatment for acute rejection within 7 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Function as Measured by 24 Hour Urine Creatinine Clearance | 6 months, 1 year, and 2 years | Renal Function was assessed by 24 hr urine collection creatinine clearance measured (mL/min). 24 Hr urine collection was assessed at baseline, 6 months, 1 year, and 2 years post transplant. |
| Renal Function as Measured by Serum Creatinine Level | 6 months, 1 year, and 2 years | Serum creatinine levels were assessed at 6 months, 1 year, and 2 years post transplant |
| Renal Function as Measured by Cockcroft Gault Creatinine Clearance | 6 months, 1 year, and 2 years | The Cockcroft-Gault formula for estimating creatinine clearance was determined at 6 months, 1 year, and 2 years post transplant |
| Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) | 6 months, 1 year, and 2 years | Modification of Diet in Renal Disease (MDRD) estimated Glomerular Filtration Rate (eGFR) was assessed at 6 months, 1 year, and 2 years post transplant. |
| Renal Function as Measured by Iothalamate Clearance | 6 months, 1 year, and 2 years | Iothalamate Clearance was assessed at 6 months, 1 year, and 2 years post transplant. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | 2 years | A blood sample was obtained from recipients and donors to measure gene polymorphism effects on metabolism of calcineurin inhibitor and everolimus. The polymorphisms are represented as the number of SNP occurrences for the CYP3A5, ABCB1 (MDR1) gene, and CYP4A4\*22 genes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Calcineurin Inhibitor and Mycophenolic Acid Calcineurin inhibitor immunosuppression with mycophenolic acid
Calcineurin Inhibitor: Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA). | 12 |
| Everolimus and Mycophenolic Acid Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Everolimus: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Total | Everolimus and Mycophenolic Acid | Calcineurin Inhibitor and Mycophenolic Acid |
|---|---|---|---|
| 24 Hour Urine Creatinine Clearance | 61.63 mL/min/1.73m2 | 59.25 mL/min/1.73m2 | 64 mL/min/1.73m2 |
| 24hr Urine Protein | 0.1925 g/24hrs | 0.19 g/24hrs | 0.2 g/24hrs |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 10 Participants | 10 Participants |
| Age, Continuous | 55.79 years | 56.5 years | 55.1 years |
| Cockcroft Gault Creatinine Clearance | 81.63 ml/min | 85.15 ml/min | 78.11 ml/min |
| Iothalamate Clearance | 59.35 ml/min | 58.10 ml/min | 60.60 ml/min |
| Modification of Diet in Renal Disease (MDRD) Clearance | 65.58 mL/min/1.73 m^2 | 69.91 mL/min/1.73 m^2 | 61.24 mL/min/1.73 m^2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 12 Participants | 11 Participants |
| Region of Enrollment United States | 24 participants | 12 participants | 12 participants |
| Serum Creatinine | 1.26 mg/dL | 1.23 mg/dL | 1.3 mg/dL |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 21 Participants | 11 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 12 / 12 | 12 / 12 |
| serious Total, serious adverse events | 0 / 12 | 1 / 12 |
Outcome results
Primary
Renal Function as Measured by 24 Hour Urine Creatinine Clearance
Renal Function was assessed by 24 hr urine collection creatinine clearance measured (mL/min). 24 Hr urine collection was assessed at baseline, 6 months, 1 year, and 2 years post transplant.
Time frame: 6 months, 1 year, and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by 24 Hour Urine Creatinine Clearance | 24hr Urine Creatinine Clearance at 6 months | 68.09 mL/min | Standard Deviation 30.08 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by 24 Hour Urine Creatinine Clearance | 24hr Urine Creatinine Clearance at 1 year | 68.09 mL/min | Standard Deviation 28.91 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by 24 Hour Urine Creatinine Clearance | 24hr Urine Creatinine Clearance at 2 years | 61.54 mL/min | Standard Deviation 27.5 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by 24 Hour Urine Creatinine Clearance | 24hr Urine Creatinine Clearance at 6 months | 70.75 mL/min | Standard Deviation 29.03 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by 24 Hour Urine Creatinine Clearance | 24hr Urine Creatinine Clearance at 1 year | 86.8 mL/min | Standard Deviation 29.34 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by 24 Hour Urine Creatinine Clearance | 24hr Urine Creatinine Clearance at 2 years | 90.63 mL/min | Standard Deviation 30.05 |
Primary
Renal Function as Measured by Cockcroft Gault Creatinine Clearance
The Cockcroft-Gault formula for estimating creatinine clearance was determined at 6 months, 1 year, and 2 years post transplant
Time frame: 6 months, 1 year, and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Cockcroft Gault Creatinine Clearance | Cockcroft Gault Creatinine Clearance at 6 months | 79.84 mL/min/1.73m2 | Standard Deviation 29.29 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Cockcroft Gault Creatinine Clearance | Cockcroft Gault Creatinine Clearance at 1 year | 86.84 mL/min/1.73m2 | Standard Deviation 37.17 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Cockcroft Gault Creatinine Clearance | Cockcroft Gault Creatinine Clearance at 2 years | 80.85 mL/min/1.73m2 | Standard Deviation 28.57 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Cockcroft Gault Creatinine Clearance | Cockcroft Gault Creatinine Clearance at 6 months | 100.17 mL/min/1.73m2 | Standard Deviation 45.39 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Cockcroft Gault Creatinine Clearance | Cockcroft Gault Creatinine Clearance at 1 year | 113.47 mL/min/1.73m2 | Standard Deviation 60.76 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Cockcroft Gault Creatinine Clearance | Cockcroft Gault Creatinine Clearance at 2 years | 108.16 mL/min/1.73m2 | Standard Deviation 60.1 |
Comparison: Statistical analysis was performed on the Cockcroft Gault Creatinine clearance 2 year data.p-value: 0.28395% CI: [-16.17, 70.8]Wilcoxon (Mann-Whitney)
Primary
Renal Function as Measured by Iothalamate Clearance
Iothalamate Clearance was assessed at 6 months, 1 year, and 2 years post transplant.
Time frame: 6 months, 1 year, and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Iothalamate Clearance | Iothalamate Clearance at 6 months | 67.99 mL/min/1.73m2 | Standard Deviation 39.23 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Iothalamate Clearance | Iothalamate Clearance at 1 year | 66.65 mL/min/1.73m2 | Standard Deviation 32.69 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Iothalamate Clearance | Iothalamate Clearance at 2 years | 57.19 mL/min/1.73m2 | Standard Deviation 24.75 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Iothalamate Clearance | Iothalamate Clearance at 6 months | 74.23 mL/min/1.73m2 | Standard Deviation 31.3 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Iothalamate Clearance | Iothalamate Clearance at 1 year | 104.01 mL/min/1.73m2 | Standard Deviation 43 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Iothalamate Clearance | Iothalamate Clearance at 2 years | 79.41 mL/min/1.73m2 | Standard Deviation 27.71 |
Comparison: Statistical analysis was performed on the Iothalamate Clearance 2 year data.p-value: 0.09995% CI: [-3.28, 47.72]Wilcoxon (Mann-Whitney)
Comparison: Power and sample size. The assumption was made that eGFR would improve from 34 mL/min/1.73 m2 to 43 mL/min/1.73 m2. It was determined that a sample size of 12 in each group would have 80% power to detect a difference in means of -9.0 (the difference between a group 1 mean of 34.0 and a group 2 mean of 43.0) assuming that the common standard deviation was 7.5 using a two group t-test with a 0.05 two-sided significance level.~Data from the 2 year time point was used for analysis.p-value: 0.03295% CI: [1.04, 57.1]Wilcoxon (Mann-Whitney)
Comparison: Statistical analysis was performed on 2 year data time point.p-value: 0.01595% CI: [-1.11, -0.003]Wilcoxon (Mann-Whitney)
Primary
Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR)
Modification of Diet in Renal Disease (MDRD) estimated Glomerular Filtration Rate (eGFR) was assessed at 6 months, 1 year, and 2 years post transplant.
Time frame: 6 months, 1 year, and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) | MDRD eGFR at 6 months | 62.18 mL/min/1.73 m2 | Standard Deviation 22.51 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) | MDRD eGFR at 1 year | 60.63 mL/min/1.73 m2 | Standard Deviation 19.68 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) | MDRD eGFR at 2 years | 53.29 mL/min/1.73 m2 | Standard Deviation 17.58 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) | MDRD eGFR at 6 months | 81.27 mL/min/1.73 m2 | Standard Deviation 31.3 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) | MDRD eGFR at 1 year | 88.01 mL/min/1.73 m2 | Standard Deviation 34.08 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) | MDRD eGFR at 2 years | 87.37 mL/min/1.73 m2 | Standard Deviation 32.09 |
Comparison: Statistical analysis was performed on the MDRD Clearance 2 year data row data.p-value: 0.01395% CI: [9.95, 58.21]Wilcoxon (Mann-Whitney)
Primary
Renal Function as Measured by Serum Creatinine Level
Serum creatinine levels were assessed at 6 months, 1 year, and 2 years post transplant
Time frame: 6 months, 1 year, and 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Serum Creatinine Level | Serum Creatinine at 6 months | 1.29 mg/dL | Standard Deviation 0.43 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Serum Creatinine Level | Serum Creatinine at 1 year | 1.29 mg/dL | Standard Deviation 0.38 |
| Calcineurin Inhibitor With Mycophenolic Acid | Renal Function as Measured by Serum Creatinine Level | Serum Creatinine at 2 years | 1.51 mg/dL | Standard Deviation 0.69 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Serum Creatinine Level | Serum Creatinine at 6 months | 1.02 mg/dL | Standard Deviation 0.24 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Serum Creatinine Level | Serum Creatinine at 1 year | 0.95 mg/dL | Standard Deviation 0.25 |
| Everolimus With Mycophenolic Acid | Renal Function as Measured by Serum Creatinine Level | Serum Creatinine at 2 years | 0.95 mg/dL | Standard Deviation 0.3 |
Other Pre-specified
Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes
A blood sample was obtained from recipients and donors to measure gene polymorphism effects on metabolism of calcineurin inhibitor and everolimus. The polymorphisms are represented as the number of SNP occurrences for the CYP3A5, ABCB1 (MDR1) gene, and CYP4A4\*22 genes.
Time frame: 2 years
Population: SNP source: rs776746 = CYP3A5 gene; rs1045642, rs1128503 and rs2032582 = ABCB1 (MDR1) gene, and rs35599367=Cyp4A4\*22 gene.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs776746 (CYP3A5 gene) | 11 Participants |
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs1045642 (ABCB1 gene) | 6 Participants |
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs1128503 (ABCB1 gene) | 7 Participants |
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs2032582 (ABCB1 gene) | 1 Participants |
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs35599367 (CYP4A4*22 gene) | 1 Participants |
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs776746 (CYP3A5 gene) | 3 Participants |
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs1045642 (ABCB1 gene) | 1 Participants |
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs1128503 (ABCB1 gene) | 0 Participants |
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs2032582 (ABCB1 gene) | 0 Participants |
| Calcineurin Inhibitor With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs35599367 (Cyp4A4*22) | 0 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs1128503 (ABCB1 gene) | 0 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs776746 (CYP3A5 gene) | 11 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs776746 (CYP3A5 gene) | 0 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs1045642 (ABCB1 gene) | 6 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs35599367 (Cyp4A4*22) | 1 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs1128503 (ABCB1 gene) | 8 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs1045642 (ABCB1 gene) | 5 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs2032582 (ABCB1 gene) | 0 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Donor Genotypes : rs2032582 (ABCB1 gene) | 0 Participants |
| Everolimus With Mycophenolic Acid | Recipient and Donor Genotyping for Selected Variants of CYP3A5, ABCB1 (MDR1), and CYP4A Genes | Recipient Genotypes : rs35599367 (CYP4A4*22 gene) | 1 Participants |