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Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients (Spartacus)

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ClinicalTrials.gov Identifier: NCT01649427
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Pharmacokinetics Study in de Novo Kidney Transplantation
Interventions Drug: Prograf
Drug: Tacrolimus Hexal
Enrollment 73
Recruitment Details 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
Pre-assignment Details

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

Arm/Group Title Tacrolimus Hexal® Prograf®
Hide Arm/Group Description 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® 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®
Period Title: Overall Study
Started 35 38
Completed 24 26
Not Completed 11 12
Reason Not Completed
Adverse Event             1             1
Withdrawal by Subject             8             7
Lost to Follow-up             0             1
Graft loss             0             1
Surgical problems during nephrectomy             2             2
Arm/Group Title Tacrolimus Hexal® Prograf® Total
Hide Arm/Group Description 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® 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® Total of all reporting groups
Overall Number of Baseline Participants 35 38 73
Hide Baseline Analysis Population Description
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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 38 participants 73 participants
47.9  (9.9) 47.2  (11.8) 47.5  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 38 participants 73 participants
Female
6
  17.1%
9
  23.7%
15
  20.5%
Male
29
  82.9%
29
  76.3%
58
  79.5%
1.Primary Outcome
Title ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set)
Hide Description

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.

Time Frame baseline to month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Tacrolimus Hexal® Prograf®
Hide Arm/Group Description:
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®
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®
Overall Number of Participants Analyzed 24 27
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mL/min
47.65
(41.70 to 53.60)
38.60
(31.32 to 45.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tacrolimus Hexal®, Prograf®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1
Hide Description 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
Time Frame end of month 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tacrolimus Hexal® Prograf®
Hide Arm/Group Description:
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®
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®
Overall Number of Participants Analyzed 23 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: h/10^3*L
Adjusted, log-transformed Estimates (ANOVA)
2.944
(2.783 to 3.105)
3.020
(2.811 to 3.228)
Adjusted, back-transformed Estimates (ANOVA)
18.991
(16.163 to 22.314)
20.484
(16.630 to 25.231)
3.Secondary Outcome
Title The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set)
Hide Description The key secondary objective was to assess the incidence of individual endpoints BPAR, graft loss and death until month 6 post-transplantation.
Time Frame baseline to month 12
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Tacrolimus Hexal® Prograf®
Hide Arm/Group Description:
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®
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®
Overall Number of Participants Analyzed 35 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Incidences
Biopsy proven acute rejection (BPAR)
2
(0.70 to 19.16)
3
(1.66 to 21.38)
Graft loss
0
(0.00 to 10.00)
1
(0.07 to 13.81)
Death
0
(0.00 to 10.00)
1
(0.07 to 13.81)
Composite: BPAR, graft loss or death
2
(0.70 to 19.16)
4
(2.94 to 24.80)
4.Secondary Outcome
Title ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantation
Hide Description ANCOVA model for change in CKD-EPI Glomerular Filtration Rate (GFR)[ml/min] without replacement of missing values
Time Frame baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Tacrolimus Hexal® Prograf®
Hide Arm/Group Description:
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®
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®
Overall Number of Participants Analyzed 24 27
Least Squares Mean (Standard Error)
Unit of Measure: mL/min
48.33  (3.84) 39.77  (4.61)
5.Secondary Outcome
Title ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing Values
Hide Description MDRD GFR
Time Frame least square (LS) mean change from baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tacrolimus Hexal® Prograf®
Hide Arm/Group Description:
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®
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®
Overall Number of Participants Analyzed 35 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: (ml/min)
46.20
(37.62 to 54.79)
38.52
(28.64 to 48.41)
6.Secondary Outcome
Title ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing Values
Hide Description change in Cockcroft-Gault GFR
Time Frame least square (LS) mean change from baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tacrolimus Hexal® Prograf®
Hide Arm/Group Description:
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®
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®
Overall Number of Participants Analyzed 35 38
Least Squares Mean (95% Confidence Interval)
Unit of Measure: (ml/min)
60.45
(52.48 to 68.41)
46.45
(36.89 to 56.02)
Time Frame [Not Specified]
Adverse Event Reporting Description One patient was randomized to Prograf but didn't receive assigned treatment hence was excluded from efficacy analyses but was kept for safety reporting
 
Arm/Group Title Tacrolimus Hexal Prograf
Hide Arm/Group Description 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® 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®
All-Cause Mortality
Tacrolimus Hexal Prograf
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tacrolimus Hexal Prograf
Affected / at Risk (%) Affected / at Risk (%)
Total   19/35 (54.29%)   17/39 (43.59%) 
Blood and lymphatic system disorders     
LEUKOPENIA  1  1/35 (2.86%)  1/39 (2.56%) 
THROMBOTIC MICROANGIOPATHY  1  0/35 (0.00%)  2/39 (5.13%) 
Cardiac disorders     
ACUTE MYOCARDIAL INFARCTION  1  1/35 (2.86%)  0/39 (0.00%) 
CORONARY ARTERY DISEASE  1  0/35 (0.00%)  1/39 (2.56%) 
Gastrointestinal disorders     
COLITIS  1  1/35 (2.86%)  0/39 (0.00%) 
DIARRHOEA  1  3/35 (8.57%)  0/39 (0.00%) 
ENTERITIS  1  0/35 (0.00%)  1/39 (2.56%) 
LARGE INTESTINE PERFORATION  1  1/35 (2.86%)  0/39 (0.00%) 
PANCREATIC PSEUDOCYST  1  1/35 (2.86%)  0/39 (0.00%) 
PANCREATITIS CHRONIC  1  1/35 (2.86%)  0/39 (0.00%) 
General disorders     
IMPAIRED HEALING  1  1/35 (2.86%)  0/39 (0.00%) 
IMPLANT SITE EXTRAVASATION  1  1/35 (2.86%)  0/39 (0.00%) 
OEDEMA PERIPHERAL  1  1/35 (2.86%)  0/39 (0.00%) 
PYREXIA  1  0/35 (0.00%)  1/39 (2.56%) 
Immune system disorders     
KIDNEY TRANSPLANT REJECTION  1  2/35 (5.71%)  2/39 (5.13%) 
Infections and infestations     
BACTERIAL SEPSIS  1  0/35 (0.00%)  1/39 (2.56%) 
BRONCHITIS  1  0/35 (0.00%)  1/39 (2.56%) 
CAMPYLOBACTER GASTROENTERITIS  1  1/35 (2.86%)  0/39 (0.00%) 
CYTOMEGALOVIRUS INFECTION  1  0/35 (0.00%)  1/39 (2.56%) 
DIVERTICULITIS  1  1/35 (2.86%)  0/39 (0.00%) 
ENTEROCOCCAL INFECTION  1  0/35 (0.00%)  1/39 (2.56%) 
HUMAN POLYOMAVIRUS INFECTION  1  0/35 (0.00%)  1/39 (2.56%) 
INFECTION  1  0/35 (0.00%)  1/39 (2.56%) 
LUNG INFECTION  1  1/35 (2.86%)  1/39 (2.56%) 
PERITONITIS  1  1/35 (2.86%)  0/39 (0.00%) 
POLYOMAVIRUS-ASSOCIATED NEPHROPATHY  1  1/35 (2.86%)  0/39 (0.00%) 
SINUSITIS  1  0/35 (0.00%)  1/39 (2.56%) 
URINARY TRACT INFECTION  1  4/35 (11.43%)  4/39 (10.26%) 
UROSEPSIS  1  2/35 (5.71%)  0/39 (0.00%) 
Injury, poisoning and procedural complications     
ABDOMINAL WOUND DEHISCENCE  1  1/35 (2.86%)  1/39 (2.56%) 
COMPLICATIONS OF TRANSPLANTED KIDNEY  1  4/35 (11.43%)  3/39 (7.69%) 
DELAYED GRAFT FUNCTION  1  1/35 (2.86%)  0/39 (0.00%) 
HUMERUS FRACTURE  1  0/35 (0.00%)  1/39 (2.56%) 
INCISIONAL HERNIA  1  2/35 (5.71%)  0/39 (0.00%) 
TOXICITY TO VARIOUS AGENTS  1  1/35 (2.86%)  0/39 (0.00%) 
TRAUMATIC HAEMOTHORAX  1  1/35 (2.86%)  0/39 (0.00%) 
Investigations     
BLOOD CREATININE INCREASED  1  4/35 (11.43%)  1/39 (2.56%) 
Metabolism and nutrition disorders     
DEHYDRATION  1  1/35 (2.86%)  0/39 (0.00%) 
HYPERKALAEMIA  1  0/35 (0.00%)  1/39 (2.56%) 
HYPOGLYCAEMIA  1  0/35 (0.00%)  1/39 (2.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
PROSTATE CANCER  1  0/35 (0.00%)  1/39 (2.56%) 
Renal and urinary disorders     
ACUTE KIDNEY INJURY  1  3/35 (8.57%)  0/39 (0.00%) 
DYSURIA  1  1/35 (2.86%)  0/39 (0.00%) 
FOCAL SEGMENTAL GLOMERULOSCLEROSIS  1  2/35 (5.71%)  0/39 (0.00%) 
PROTEINURIA  1  3/35 (8.57%)  0/39 (0.00%) 
RENAL FAILURE  1  0/35 (0.00%)  1/39 (2.56%) 
RENAL IMPAIRMENT  1  2/35 (5.71%)  1/39 (2.56%) 
URETERAL NECROSIS  1  0/35 (0.00%)  1/39 (2.56%) 
URETERIC STENOSIS  1  1/35 (2.86%)  1/39 (2.56%) 
URINARY INCONTINENCE  1  0/35 (0.00%)  1/39 (2.56%) 
URINARY RETENTION  1  1/35 (2.86%)  0/39 (0.00%) 
URINARY TRACT DISORDER  1  1/35 (2.86%)  0/39 (0.00%) 
URINARY TRACT OBSTRUCTION  1  0/35 (0.00%)  1/39 (2.56%) 
URINOMA  1  1/35 (2.86%)  0/39 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
PULMONARY EMBOLISM  1  1/35 (2.86%)  0/39 (0.00%) 
SLEEP APNOEA SYNDROME  1  1/35 (2.86%)  0/39 (0.00%) 
Skin and subcutaneous tissue disorders     
SKIN ULCER  1  1/35 (2.86%)  0/39 (0.00%) 
Vascular disorders     
VARICOSE VEIN  1  0/35 (0.00%)  1/39 (2.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tacrolimus Hexal Prograf
Affected / at Risk (%) Affected / at Risk (%)
Total   34/35 (97.14%)   38/39 (97.44%) 
Blood and lymphatic system disorders     
ANAEMIA  1  4/35 (11.43%)  7/39 (17.95%) 
LEUKOCYTOSIS  1  0/35 (0.00%)  2/39 (5.13%) 
LEUKOPENIA  1  3/35 (8.57%)  7/39 (17.95%) 
NEPHROGENIC ANAEMIA  1  5/35 (14.29%)  2/39 (5.13%) 
Cardiac disorders     
SINUS TACHYCARDIA  1  1/35 (2.86%)  2/39 (5.13%) 
Gastrointestinal disorders     
ABDOMINAL PAIN  1  0/35 (0.00%)  2/39 (5.13%) 
ABDOMINAL PAIN UPPER  1  0/35 (0.00%)  2/39 (5.13%) 
CONSTIPATION  1  2/35 (5.71%)  6/39 (15.38%) 
DIARRHOEA  1  5/35 (14.29%)  5/39 (12.82%) 
FLATULENCE  1  3/35 (8.57%)  4/39 (10.26%) 
HIATUS HERNIA  1  1/35 (2.86%)  3/39 (7.69%) 
NAUSEA  1  2/35 (5.71%)  5/39 (12.82%) 
VOMITING  1  1/35 (2.86%)  3/39 (7.69%) 
General disorders     
IMPAIRED HEALING  1  1/35 (2.86%)  2/39 (5.13%) 
OEDEMA PERIPHERAL  1  3/35 (8.57%)  7/39 (17.95%) 
PYREXIA  1  1/35 (2.86%)  3/39 (7.69%) 
Immune system disorders     
KIDNEY TRANSPLANT REJECTION  1  1/35 (2.86%)  4/39 (10.26%) 
Infections and infestations     
CYTOMEGALOVIRUS INFECTION  1  1/35 (2.86%)  4/39 (10.26%) 
CYTOMEGALOVIRUS VIRAEMIA  1  2/35 (5.71%)  0/39 (0.00%) 
NASOPHARYNGITIS  1  2/35 (5.71%)  3/39 (7.69%) 
PNEUMONIA  1  0/35 (0.00%)  2/39 (5.13%) 
SEPSIS  1  0/35 (0.00%)  2/39 (5.13%) 
UPPER RESPIRATORY TRACT INFECTION  1  2/35 (5.71%)  1/39 (2.56%) 
URINARY TRACT INFECTION  1  6/35 (17.14%)  16/39 (41.03%) 
WOUND INFECTION  1  0/35 (0.00%)  2/39 (5.13%) 
Injury, poisoning and procedural complications     
COMPLICATIONS OF TRANSPLANTED KIDNEY  1  5/35 (14.29%)  11/39 (28.21%) 
POST PROCEDURAL HAEMATOMA  1  2/35 (5.71%)  3/39 (7.69%) 
PROCEDURAL PAIN  1  2/35 (5.71%)  1/39 (2.56%) 
RENAL LYMPHOCELE  1  4/35 (11.43%)  3/39 (7.69%) 
WOUND COMPLICATION  1  16/35 (45.71%)  19/39 (48.72%) 
WOUND DEHISCENCE  1  2/35 (5.71%)  1/39 (2.56%) 
Investigations     
BLOOD CREATININE INCREASED  1  2/35 (5.71%)  6/39 (15.38%) 
C-REACTIVE PROTEIN INCREASED  1  0/35 (0.00%)  2/39 (5.13%) 
HEPATIC ENZYME INCREASED  1  0/35 (0.00%)  3/39 (7.69%) 
Metabolism and nutrition disorders     
ACIDOSIS  1  0/35 (0.00%)  2/39 (5.13%) 
DIABETES MELLITUS  1  3/35 (8.57%)  2/39 (5.13%) 
HYPERCALCAEMIA  1  1/35 (2.86%)  2/39 (5.13%) 
HYPERCHOLESTEROLAEMIA  1  2/35 (5.71%)  1/39 (2.56%) 
HYPERKALAEMIA  1  9/35 (25.71%)  9/39 (23.08%) 
HYPERLIPIDAEMIA  1  3/35 (8.57%)  1/39 (2.56%) 
HYPERPHOSPHATAEMIA  1  1/35 (2.86%)  2/39 (5.13%) 
HYPERURICAEMIA  1  3/35 (8.57%)  9/39 (23.08%) 
HYPOCALCAEMIA  1  5/35 (14.29%)  4/39 (10.26%) 
HYPOKALAEMIA  1  5/35 (14.29%)  4/39 (10.26%) 
HYPOMAGNESAEMIA  1  5/35 (14.29%)  7/39 (17.95%) 
HYPOPHOSPHATAEMIA  1  3/35 (8.57%)  2/39 (5.13%) 
IRON DEFICIENCY  1  0/35 (0.00%)  2/39 (5.13%) 
METABOLIC ACIDOSIS  1  2/35 (5.71%)  3/39 (7.69%) 
VITAMIN D DEFICIENCY  1  2/35 (5.71%)  6/39 (15.38%) 
Nervous system disorders     
HEADACHE  1  4/35 (11.43%)  1/39 (2.56%) 
TREMOR  1  3/35 (8.57%)  2/39 (5.13%) 
Psychiatric disorders     
INSOMNIA  1  4/35 (11.43%)  6/39 (15.38%) 
RESTLESSNESS  1  0/35 (0.00%)  2/39 (5.13%) 
SLEEP DISORDER  1  3/35 (8.57%)  1/39 (2.56%) 
Renal and urinary disorders     
ACUTE KIDNEY INJURY  1  0/35 (0.00%)  2/39 (5.13%) 
BLADDER PAIN  1  5/35 (14.29%)  3/39 (7.69%) 
BLADDER SPASM  1  0/35 (0.00%)  3/39 (7.69%) 
OLIGURIA  1  0/35 (0.00%)  2/39 (5.13%) 
RENAL FAILURE  1  0/35 (0.00%)  2/39 (5.13%) 
RENAL HYPERTENSION  1  0/35 (0.00%)  4/39 (10.26%) 
URINARY RETENTION  1  2/35 (5.71%)  1/39 (2.56%) 
Respiratory, thoracic and mediastinal disorders     
DYSPNOEA  1  0/35 (0.00%)  2/39 (5.13%) 
Skin and subcutaneous tissue disorders     
ACNE  1  2/35 (5.71%)  0/39 (0.00%) 
ALOPECIA  1  0/35 (0.00%)  2/39 (5.13%) 
SCAR PAIN  1  0/35 (0.00%)  2/39 (5.13%) 
Vascular disorders     
HYPERTENSION  1  12/35 (34.29%)  20/39 (51.28%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: (862) 778-8300
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Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01649427     History of Changes
Other Study ID Numbers: CERL080ADE27
First Submitted: July 20, 2012
First Posted: July 25, 2012
Results First Submitted: August 19, 2016
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019