Not provided
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due to low study enrollment
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The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).
Corticosteroids (one specific type is prednisone) have been used in clinical transplantation for more than 30 years. There are many side effects of corticosteroids including significant bone disease, diabetes (elevated blood sugar levels), fluid retention and hypertension (high blood pressure), psychosis, peptic ulcer disease, hyperlipidemia (elevated lipid levels such as cholesterol and triglycerides), obesity (overweight), acne, and susceptibility to infections. It is hoped that the new generation of potent immunosuppressive medications (such as Prograf and CellCept) will permit avoidance or withdrawal of corticosteroids for the majority of patients to avoid both short- and long-term complications of corticosteroid use in kidney transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone Withdrawal | Experimental | Participants randomized to the prednisone withdrawal group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was given intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered to participants an inpatient or outpatient for a total of 3 to 5 doses. Participants also began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued indefinitely. The steroids were initially given in the operating room intravenously at time of transplant as Solu-medrol (methylprednisolone)and were then switched to daily oral prednisone doses. The participant's dose of prednisone was rapidly decreased until it was completely eliminated by day 6 post-transplant. |
|
| Prednisone Maintenance | Active Comparator | Participants randomized to the prednisone maintenance group, received 4 medications to prevent rejection. Thymoglobulin (rabbit antithymocyte globulin) was initiated intravenously in the operating room at the time of transplant. Subsequent intravenous doses were administered an inpatient or outpatient for a total of 3 to 5 doses. Participants began taking Prograf (tacrolimus) and CellCept (mycophenolate mofetil)orally within 24 hours of transplant and continued on them indefinitely. The steroids were initially given intravenously in the operating room at time of transplant as Solu-medrol (methylprednisolone) and were then switched to daily oral prednisone tablets. Participants remained on all drugs according to their doctor's standard of care, and the prednisone was not be eliminated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednisone | Drug | In this group, participants had prednisone rapidly decreased until completely eliminated by day 6 after transplant. Participants began on 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20mg on day 5, none from day 6-on. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Acute Rejection Episodes | Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported. | 6 and 12 months post-transplant |
| The Number of Participants With Graft Survival | The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported. | 6 and 12 months |
| Participant Survival | The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival. | 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Treatment Failures | This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial) | 12 months |
| Length of Hospital Stay After Transplant |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Simin Goral, MD | University of Pennsylvania-Renal Electrolyte and Hypertension Division | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Study was terminated early due to low enrollment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone Withdrawal | Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant. |
| FG001 | Prednisone Maintenance | Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone Withdrawal | Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With Acute Rejection Episodes | Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported. | data not interpretable due to low patient enrollment | Posted | 6 and 12 months post-transplant |
|
up to 24 months post-transplant
Patients and their data were reviewed by the principal investigator at regular follow-up visits, hospital readmissions and study visits.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prednisone Withdrawal | Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gangrene | Vascular disorders | Systematic Assessment | Gangrene of left toe, same patient had gangrene of right toe in past |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| wound drainage | Surgical and medical procedures | Systematic Assessment | no bug identified |
The trial was terminated early due to low enrollment. Therefore no results beyond basic results section are reported due to uninterpretable data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Trofe-Clark, Clinical Transplant Research Pharmacist | Hospital of the University of Pennsylvania | 215-614-4274 | jennifer.trofe-clark@uphs.upenn.edu |
Not provided
| ID | Term |
|---|---|
| D011241 | Prednisone |
| D013256 | Steroids |
| D008775 | Methylprednisolone |
| D000305 | Adrenal Cortex Hormones |
| C512542 | thymoglobulin |
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D000072473 | Fused-Ring Compounds |
Not provided
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Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| rabbit antithymocyte globulin | Drug | Participants in both groups received 3 to 5 doses of an intravenous medication to prevent rejection called Thymoglobulin (rabbit antithymocyte globulin) as per our standard of care. This drug was dosed at 1.5 milligrams/killograms per dose and dosing was then based on body weight. The dose was decreased in half or held if the participant had a low white blood cell count or if the participant a low platelet count. The first dose was given intravenously in the operating room and subsequent intravenous doses were administered either while participants were inpatients or outpatients for a total of 3 to 5 doses for a total of up to 6mg/kg. The number of doses was based on transplant kidney function and risk factors for rejection. |
|
|
| Tacrolimus | Drug | Participants in both groups received tacrolimus per our standard of care. This medication helped to prevent rejection and was initially dosed at 0.1-0.2 milligrams/killograms/day in two divided doses, given orally, based on participant's body weight. We then looked at the trough levels of this medication(the lowest level before the next dose), and aimed to keep the trough level between 5-10 nanograms/milliliter throughout the study. |
|
|
| Prednisone | Drug | Participants in this group continued on prednisone indefinitely. Participants began with 500mg of intravenous methylprednisolone on the day of transplant, followed by the following doses of oral prednisone: 160mg on day 1, 120mg on day 2, 80mg on day 3, 40mg on day 4, 20 mg days 5-9, 15 mg day 10-19, 10 mg day 20-24, 7.5 mg day 25-29, and 5mg from day 30-on indefinitely. |
|
|
| Mycophenolate mofetil | Drug | Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone withdrawal group was 1000mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea. |
|
|
| Mycophenolate mofetil | Drug | Participants in both groups received mycophenolate mofetil by mouth twice daily indefinitely. Dosing for patients in the Prednisone maintenance group was 500 mg orally twice daily. The dose was decreased or held at the discretion of the physician, for side effects such as low white blood cell count, or low platelet count, or if the participant experienced stomach side effects such as heartburn, nausea, vomiting or diarrhea. |
|
|
The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge.
| 12 months |
| The Number of Participants With Hospital Readmissions | The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions. | 12 months |
| The Length of Stay Associated With Hospital Readmissions | The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant. | 12 months |
| Participant Renal Function as Measured by MDRD Formula | The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant. | 3, 6 and 12 months |
| Participant Renal Function as Measured by 24 Hour Urine Collection | Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function. | 3 and 12 months post-transplant |
| The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes. | The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician. | 12 months |
| The Number of Participants With Leukopenia | All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL). | 12 months |
| The Number of Participants With Infections | Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant. | 12 months |
| The Number of Participants With Malignancy | Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator. | 12 months |
| The Number of Participants With Hypertension | The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study. | 12 months |
| The Number of Participants With Hyperlipidemia | Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines. | 12 months |
| The Number of Participants With Bone Disease | Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months. | baseline (within 1 month post-transplant), 3, 6, 12 and 24 months |
| The Number of Participants With Post Transplant Diabetes Mellitus | Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months. Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants. | pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months |
| The Number of Participants With Weight Gain | Height, weight will be used to calculate change in BMI for all participants. | 12 months |
| BG001 | Prednisone Maintenance | Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Prednisone Maintenance | Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated. |
|
| Secondary | The Number of Participants With Treatment Failures | This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial) | Unable to interpret data due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | Length of Hospital Stay After Transplant | The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge. | unable to interpret results due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | The Number of Participants With Hospital Readmissions | The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions. | Unable to interpret data due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | The Length of Stay Associated With Hospital Readmissions | The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant. | Unable to interpret data due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | Participant Renal Function as Measured by MDRD Formula | The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant. | Unable to interpret data due to low number of patients enrolled. | Posted | 3, 6 and 12 months |
|
|
| Secondary | Participant Renal Function as Measured by 24 Hour Urine Collection | Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function. | Unable to interpret data due to low number of patients enrolled. | Posted | 3 and 12 months post-transplant |
|
|
| Primary | The Number of Participants With Graft Survival | The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported. | data not interpretable due to low patient enrollment | Posted | 6 and 12 months |
|
|
| Primary | Participant Survival | The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival. | data not interpretable due to low patient enrollment | Posted | 6 and 12 months |
|
|
| Secondary | The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes. | The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician. | unable to interpret results due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | The Number of Participants With Leukopenia | All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL). | unable to interpret results due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | The Number of Participants With Infections | Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant. | Unable to interpret data due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | The Number of Participants With Malignancy | Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator. | Unable to interpret data due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | The Number of Participants With Hypertension | The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study. | unable to interpret results due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | The Number of Participants With Hyperlipidemia | Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines. | Unable to interpret data due to low number of patients enrolled. | Posted | 12 months |
|
|
| Secondary | The Number of Participants With Bone Disease | Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months. | unable to interpret results due to low number of patients enrolled. | Posted | baseline (within 1 month post-transplant), 3, 6, 12 and 24 months |
|
|
| Secondary | The Number of Participants With Post Transplant Diabetes Mellitus | Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months. Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants. | unable to interpret results due to low number of patients enrolled. | Posted | pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months |
|
|
| Secondary | The Number of Participants With Weight Gain | Height, weight will be used to calculate change in BMI for all participants. | unable to interpret results due to low number of patients enrolled. | Posted | 12 months |
|
|
| 0 |
| 9 |
| 4 |
| 9 |
| 8 |
| 9 |
| EG001 | Prednisone Maintenance | Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated. | 0 | 9 | 4 | 9 | 8 | 9 |
|
| lower extremity edema | Renal and urinary disorders | Systematic Assessment |
|
| shortness of breath | Cardiac disorders | Systematic Assessment |
|
| hyperkalemia | Renal and urinary disorders | Systematic Assessment |
|
| cytomegalovirus | Infections and infestations | Systematic Assessment |
|
| post transplant lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | was Epstein Barr positive, involved tongue and brain lesions, was ongoing at end of follow-up |
|
| lymphocele | Injury, poisoning and procedural complications | Systematic Assessment | Both events occurred post kidney transplant |
|
| perinephric fluid collection | Surgical and medical procedures | Systematic Assessment | This subject also had a prior lymphocele |
|
| fever | General disorders | Systematic Assessment | One patient had fever with perinephric fluid collection. Gram negative rods reported from fluid but not further identified. Other patient with fever was thought to have urinary tract infection, though no bug was identified. |
|
| hyperglycemia | Endocrine disorders | Systematic Assessment | Neither patient was noted to be diabetic pre-transplant. |
|
| acute cellular rejection | Immune system disorders | Systematic Assessment |
|
| basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| seizure | Nervous system disorders | Systematic Assessment |
|
| 3 Vessel CABG | Cardiac disorders | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | Systematic Assessment | bug identified as serratia marcescens |
|
| fungal infection of toes | Infections and infestations | Systematic Assessment |
|
| lower extremity edema | Renal and urinary disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| shortness of breath | Cardiac disorders | Systematic Assessment |
|
| lightheadedness | Cardiac disorders | Systematic Assessment | same patient also had shortness of breath |
|
| hypertension | Renal and urinary disorders | Systematic Assessment |
|
| pain in right calf | General disorders | Systematic Assessment |
|
| depression | Psychiatric disorders | Systematic Assessment | patient lost to follow-up |
|
| hyperkalemia | Renal and urinary disorders | Systematic Assessment |
|
| increased serum creatinine | Renal and urinary disorders | Systematic Assessment |
|
| leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| recurrence of gout | Metabolism and nutrition disorders | Systematic Assessment |
|
| increased tacrolimus trough level | Injury, poisoning and procedural complications | Systematic Assessment |
|
| hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| hypophosphatemia | Renal and urinary disorders | Systematic Assessment |
|
| hand tremors related to tacrolimus therapy | Injury, poisoning and procedural complications | Systematic Assessment |
|
| lymphocele | Blood and lymphatic system disorders | Systematic Assessment | hospitalization was not required for any of these cases |
|
| reaccumulation of peritransplant fluid collection | Injury, poisoning and procedural complications | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment | one patient also presented with concurrent vomiting |
|
| seasonal allergies | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| anemia | Renal and urinary disorders | Systematic Assessment |
|
| osteopenia | Metabolism and nutrition disorders | Systematic Assessment | One patient presented with concurrent osteoporosis of femoral region |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment | patient presented with concurrent diarrhea |
|
| osteoporosis | Metabolism and nutrition disorders | Systematic Assessment | patient presented with concurrent osteopenia of lumbar area |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| increased hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| bronchitis | Infections and infestations | Systematic Assessment |
|
| blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| hypokalemia | Renal and urinary disorders | Systematic Assessment |
|
| hypercalcemia | Renal and urinary disorders | Systematic Assessment |
|
| hypocalcemia | Renal and urinary disorders | Systematic Assessment |
|
| leg cramps | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| headache every morning | General disorders | Systematic Assessment |
|
| nocturia | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| D011083 |
| Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |