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The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal function.
In Phase II of this study there was a high patient drop-out rate and an associated long recruitment timespan. Eighty-one patients were recruited to Phase I and only 45 of the required 54 patients were available for PK analysis. To complete Phase II, 245 (in addition to 81) patients were to be required to achieve calculated sample size. Therefore the protocol was amended to stop recruitment and analyze Phase I patient data of CERL080ADE27 (PK-Phase I). Patients that were still ongoing were scheduled for an end of study (EOS) visit. During this visit patients were informed by the investigator about the end of study and advised about further treatment course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prograf | Experimental | Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® |
|
| Tacroliums Hexal | Experimental | Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prograf | Drug | Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set) | Change in Nankivell glomerular filtration rate (GFR) from baseline to 6 months Glomerular Filtration Rate (GFR): The GFR is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. Several studies have shown that in patients with progressive renal disease, GFR declines or reciprocal serum creatinine levels elevate linearly over time in a predictable manner. With the help of the serum creatinine values, the GFR was calculated via Nankivell formula. | baseline to month 6 |
| ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1 | Compares the PK of Tacrolimus Hexal® assessed by the ratio of the AUC0-12h over one month period post transplantation vs. Prograf® in renal transplant patients | end of month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set) | The key secondary objective was to assess the incidence of individual endpoints BPAR, graft loss and death until month 6 post-transplantation. | baseline to month 12 |
| ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantation |
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Inclusion:
primary or sec. kidney transplanted patiens, written consent, cold ischemia < 24 h
Exclusion:
multi organ, immunological risc pts., PRA >20%, Antibodys against HLA-type of donor organ, hypersensitivity against Tacro or MMF,
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Berlin | 10098 | Germany | |||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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This is a 2-phase study:
PHASE I:
In 1st phase of study, PK parameters were evaluated in total of 60 evaluable patients (30 patients per treatment group)
Phase II was not conducted
81 patients were randomized, but only 73 were assigned drug. 1 patient who was excluded from efficacy analyses, was randomized to Prograf but did not receive treatment but kept for safety reporting. 74 patients were used for safety analysis while only 73 were available for efficacy analysis
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| ID | Title | Description |
|---|---|---|
| FG000 | Tacrolimus Hexal® | Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® |
| FG001 | Prograf® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tacrolimus Hexal | Drug | Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg, 1 mg and 1.5 mg. |
|
ANCOVA model for change in CKD-EPI Glomerular Filtration Rate (GFR)[ml/min] without replacement of missing values |
| baseline to Month 6 |
| ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing Values | MDRD GFR | least square (LS) mean change from baseline to Month 6 |
| ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing Values | change in Cockcroft-Gault GFR | least square (LS) mean change from baseline to Month 6 |
| Bochum |
| 44892 |
| Germany |
| Novartis Investigative Site | Düsseldorf | 40225 | Germany |
| Novartis Investigative Site | Kaiserslautern | 67655 | Germany |
| Novartis Investigative Site | Koeln-Merheim | 51109 | Germany |
Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization
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| ID | Title | Description |
|---|---|---|
| BG000 | Tacrolimus Hexal® | Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® |
| BG001 | Prograf® | Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set) | Change in Nankivell glomerular filtration rate (GFR) from baseline to 6 months Glomerular Filtration Rate (GFR): The GFR is the best clinical estimate of renal function in health and disease, and correlates well with the clinical severity of renal function disturbances. Several studies have shown that in patients with progressive renal disease, GFR declines or reciprocal serum creatinine levels elevate linearly over time in a predictable manner. With the help of the serum creatinine values, the GFR was calculated via Nankivell formula. | The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Least Squares Mean | 95% Confidence Interval | mL/min | baseline to month 6 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set) | The key secondary objective was to assess the incidence of individual endpoints BPAR, graft loss and death until month 6 post-transplantation. | The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Number | 95% Confidence Interval | Incidences | baseline to month 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantation | ANCOVA model for change in CKD-EPI Glomerular Filtration Rate (GFR)[ml/min] without replacement of missing values | The Full Analysis Set (FAS) consisted of all patients in whom study treatment was assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization | Posted | Least Squares Mean | Standard Error | mL/min | baseline to Month 6 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1 | Compares the PK of Tacrolimus Hexal® assessed by the ratio of the AUC0-12h over one month period post transplantation vs. Prograf® in renal transplant patients | Posted | Least Squares Mean | 90% Confidence Interval | h/10^3*L | end of month 1 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing Values | MDRD GFR | Posted | Least Squares Mean | 95% Confidence Interval | (ml/min) | least square (LS) mean change from baseline to Month 6 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing Values | change in Cockcroft-Gault GFR | Posted | Least Squares Mean | 95% Confidence Interval | (ml/min) | least square (LS) mean change from baseline to Month 6 |
|
|
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One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tacrolimus Hexal | Investigational therapy: one capsule containing 0.5mg, 1mg or 5mg Tacrolimus Hexal®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® | 19 | 35 | 34 | 35 | ||
| EG001 | Prograf | Control therapy: one capsule containing 0.5 mg, 1mg or 5mg Prograf®, one tablet containing 180mg or 360mg Myfortic®, corticosteroids and one vial containing 20mg lyophilisate Simulect® | 17 | 39 | 38 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| THROMBOTIC MICROANGIOPATHY | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PANCREATIC PSEUDOCYST | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PANCREATITIS CHRONIC | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| IMPAIRED HEALING | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| IMPLANT SITE EXTRAVASATION | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| KIDNEY TRANSPLANT REJECTION | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| BACTERIAL SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| CAMPYLOBACTER GASTROENTERITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| ENTEROCOCCAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| HUMAN POLYOMAVIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| POLYOMAVIRUS-ASSOCIATED NEPHROPATHY | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| ABDOMINAL WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| COMPLICATIONS OF TRANSPLANTED KIDNEY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| DELAYED GRAFT FUNCTION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| TRAUMATIC HAEMOTHORAX | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| FOCAL SEGMENTAL GLOMERULOSCLEROSIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PROTEINURIA | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| URETERAL NECROSIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| URETERIC STENOSIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| URINARY TRACT DISORDER | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| URINOMA | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VARICOSE VEIN | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| NEPHROGENIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| FLATULENCE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HIATUS HERNIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| IMPAIRED HEALING | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| KIDNEY TRANSPLANT REJECTION | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS VIRAEMIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| WOUND INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| COMPLICATIONS OF TRANSPLANTED KIDNEY | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| POST PROCEDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| RENAL LYMPHOCELE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| WOUND COMPLICATION | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| HEPATIC ENZYME INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| ACIDOSIS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| RESTLESSNESS | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SLEEP DISORDER | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| BLADDER PAIN | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| BLADDER SPASM | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| OLIGURIA | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| RENAL HYPERTENSION | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| SCAR PAIN | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
1 patient was randomized to Prograf but didn't get treatment and was excluded from efficacy analyses but kept for safety reporting. Phase 2 was not started due to high drop-out rate. 73 enrolled; 43 of the planned 54 were available for PK analysis
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | (862) 778-8300 |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
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