Spartacus: Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01649427
Collaborator
(none)
73
5
2
34.1
14.6
0.4
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
73 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients
Actual Study Start Date
:
Oct 17, 2012
Actual Primary Completion Date
:
Aug 20, 2015
Actual Study Completion Date
:
Aug 20, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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® |
Drug: Prograf
Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths.
|
| Experimental: Tacroliums 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® |
Drug: Tacrolimus Hexal
Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg,
1 mg and 1.5 mg.
|
Outcome Measures
Primary Outcome Measures
- ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set) [baseline to month 6]
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.
- ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1 [end of 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
Secondary Outcome Measures
- The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set) [baseline to month 12]
The key secondary objective was to assess the incidence of individual endpoints BPAR, graft loss and death until month 6 post-transplantation.
- ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantation [baseline to Month 6]
ANCOVA model for change in CKD-EPI Glomerular Filtration Rate (GFR)[ml/min] without replacement of missing values
- ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing Values [least square (LS) mean change from baseline to Month 6]
MDRD GFR
- ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing Values [least square (LS) mean change from baseline to Month 6]
change in Cockcroft-Gault GFR
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Berlin | Germany | 10098 | |
| 2 | Novartis Investigative Site | Bochum | Germany | 44892 | |
| 3 | Novartis Investigative Site | Duesseldorf | Germany | 40225 | |
| 4 | Novartis Investigative Site | Kaiserslautern | Germany | 67655 | |
| 5 | Novartis Investigative Site | Koeln-Merheim | Germany | 51109 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01649427
Other Study ID Numbers:
- CERL080ADE27
First Posted:
Jul 25, 2012
Last Update Posted:
Jun 17, 2019
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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 Detail | 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® |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Tacrolimus Hexal® | Prograf® | Total |
|---|---|---|---|
| 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 Participants | 35 | 38 | 73 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
47.9
(9.9)
|
47.2
(11.8)
|
47.5
(10.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
17.1%
|
9
23.7%
|
15
20.5%
|
| Male |
29
82.9%
|
29
76.3%
|
58
79.5%
|
Outcome Measures
| Title | ANCOVA Model for Change in Nankivell GFR (mL/Min) at Month 6, Without Replacement of Missing Values (Full Analysis Set) |
|---|---|
| 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 |
Outcome Measure Data
| 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® |
|---|---|---|
| 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® |
| Measure Participants | 24 | 27 |
| Least Squares Mean (95% Confidence Interval) [mL/min] |
47.65
(20.24)
|
38.60
(18.83)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tacrolimus Hexal®, Prograf® |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Non-inferiority | |
| Statistical Test of Hypothesis | p-Value | 0.0003 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
| Title | The Incidence of Biopsy-proven Acute Rejection (BPAR), Graft Loss and Death Until Month 12 (Full Analysis Set) (Full Analysis Set) |
|---|---|
| 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 |
Outcome Measure Data
| 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® |
|---|---|---|
| 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® |
| Measure Participants | 35 | 38 |
| Biopsy proven acute rejection (BPAR) |
2
|
3
|
| Graft loss |
0
|
1
|
| Death |
0
|
1
|
| Composite: BPAR, graft loss or death |
2
|
4
|
| Title | ANCOVA Model for Change in CKD-EPI GFR (Chronic Kidney Disease Epidemiology Collaboration Glomerular Filtration Rate) at Month 6 Post-transplantation |
|---|---|
| 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 |
Outcome Measure Data
| 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® |
|---|---|---|
| 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® |
| Measure Participants | 24 | 27 |
| Least Squares Mean (Standard Error) [mL/min] |
48.33
(3.84)
|
39.77
(4.61)
|
| Title | ANOVA for Dose-normalized Tacrolimus 12-h-AUC (h/103*L) at Month 1 |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tacrolimus Hexal® | Prograf® |
|---|---|---|
| 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® |
| Measure Participants | 23 | 20 |
| Adjusted, log-transformed Estimates (ANOVA) |
2.944
|
3.020
|
| Adjusted, back-transformed Estimates (ANOVA) |
18.991
|
20.484
|
| Title | ANCOVA Model for Change in MDRD GFR (ml/Min) at Month 6, Without Replacement of Missing Values |
|---|---|
| Description | MDRD GFR |
| Time Frame | least square (LS) mean change from baseline to Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tacrolimus Hexal® | Prograf® |
|---|---|---|
| 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® |
| Measure Participants | 35 | 38 |
| Least Squares Mean (95% Confidence Interval) [(ml/min)] |
46.20
|
38.52
|
| Title | ANCOVA Model for Change in Cockcroft-Gault GFR (ml/Min) at Month 6, Without Replacement of Missing Values |
|---|---|
| Description | change in Cockcroft-Gault GFR |
| Time Frame | least square (LS) mean change from baseline to Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Tacrolimus Hexal® | Prograf® |
|---|---|---|
| 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® |
| Measure Participants | 35 | 38 |
| Least Squares Mean (95% Confidence Interval) [(ml/min)] |
60.45
|
46.45
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Tacrolimus Hexal | Prograf | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/35 (54.3%) | 17/39 (43.6%) | ||
| Blood and lymphatic system disorders | ||||
| LEUKOPENIA | 1/35 (2.9%) | 1/39 (2.6%) | ||
| THROMBOTIC MICROANGIOPATHY | 0/35 (0%) | 2/39 (5.1%) | ||
| Cardiac disorders | ||||
| ACUTE MYOCARDIAL INFARCTION | 1/35 (2.9%) | 0/39 (0%) | ||
| CORONARY ARTERY DISEASE | 0/35 (0%) | 1/39 (2.6%) | ||
| Gastrointestinal disorders | ||||
| COLITIS | 1/35 (2.9%) | 0/39 (0%) | ||
| DIARRHOEA | 3/35 (8.6%) | 0/39 (0%) | ||
| ENTERITIS | 0/35 (0%) | 1/39 (2.6%) | ||
| LARGE INTESTINE PERFORATION | 1/35 (2.9%) | 0/39 (0%) | ||
| PANCREATIC PSEUDOCYST | 1/35 (2.9%) | 0/39 (0%) | ||
| PANCREATITIS CHRONIC | 1/35 (2.9%) | 0/39 (0%) | ||
| General disorders | ||||
| IMPAIRED HEALING | 1/35 (2.9%) | 0/39 (0%) | ||
| IMPLANT SITE EXTRAVASATION | 1/35 (2.9%) | 0/39 (0%) | ||
| OEDEMA PERIPHERAL | 1/35 (2.9%) | 0/39 (0%) | ||
| PYREXIA | 0/35 (0%) | 1/39 (2.6%) | ||
| Immune system disorders | ||||
| KIDNEY TRANSPLANT REJECTION | 2/35 (5.7%) | 2/39 (5.1%) | ||
| Infections and infestations | ||||
| BACTERIAL SEPSIS | 0/35 (0%) | 1/39 (2.6%) | ||
| BRONCHITIS | 0/35 (0%) | 1/39 (2.6%) | ||
| CAMPYLOBACTER GASTROENTERITIS | 1/35 (2.9%) | 0/39 (0%) | ||
| CYTOMEGALOVIRUS INFECTION | 0/35 (0%) | 1/39 (2.6%) | ||
| DIVERTICULITIS | 1/35 (2.9%) | 0/39 (0%) | ||
| ENTEROCOCCAL INFECTION | 0/35 (0%) | 1/39 (2.6%) | ||
| HUMAN POLYOMAVIRUS INFECTION | 0/35 (0%) | 1/39 (2.6%) | ||
| INFECTION | 0/35 (0%) | 1/39 (2.6%) | ||
| LUNG INFECTION | 1/35 (2.9%) | 1/39 (2.6%) | ||
| PERITONITIS | 1/35 (2.9%) | 0/39 (0%) | ||
| POLYOMAVIRUS-ASSOCIATED NEPHROPATHY | 1/35 (2.9%) | 0/39 (0%) | ||
| SINUSITIS | 0/35 (0%) | 1/39 (2.6%) | ||
| URINARY TRACT INFECTION | 4/35 (11.4%) | 4/39 (10.3%) | ||
| UROSEPSIS | 2/35 (5.7%) | 0/39 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| ABDOMINAL WOUND DEHISCENCE | 1/35 (2.9%) | 1/39 (2.6%) | ||
| COMPLICATIONS OF TRANSPLANTED KIDNEY | 4/35 (11.4%) | 3/39 (7.7%) | ||
| DELAYED GRAFT FUNCTION | 1/35 (2.9%) | 0/39 (0%) | ||
| HUMERUS FRACTURE | 0/35 (0%) | 1/39 (2.6%) | ||
| INCISIONAL HERNIA | 2/35 (5.7%) | 0/39 (0%) | ||
| TOXICITY TO VARIOUS AGENTS | 1/35 (2.9%) | 0/39 (0%) | ||
| TRAUMATIC HAEMOTHORAX | 1/35 (2.9%) | 0/39 (0%) | ||
| Investigations | ||||
| BLOOD CREATININE INCREASED | 4/35 (11.4%) | 1/39 (2.6%) | ||
| Metabolism and nutrition disorders | ||||
| DEHYDRATION | 1/35 (2.9%) | 0/39 (0%) | ||
| HYPERKALAEMIA | 0/35 (0%) | 1/39 (2.6%) | ||
| HYPOGLYCAEMIA | 0/35 (0%) | 1/39 (2.6%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| PROSTATE CANCER | 0/35 (0%) | 1/39 (2.6%) | ||
| Renal and urinary disorders | ||||
| ACUTE KIDNEY INJURY | 3/35 (8.6%) | 0/39 (0%) | ||
| DYSURIA | 1/35 (2.9%) | 0/39 (0%) | ||
| FOCAL SEGMENTAL GLOMERULOSCLEROSIS | 2/35 (5.7%) | 0/39 (0%) | ||
| PROTEINURIA | 3/35 (8.6%) | 0/39 (0%) | ||
| RENAL FAILURE | 0/35 (0%) | 1/39 (2.6%) | ||
| RENAL IMPAIRMENT | 2/35 (5.7%) | 1/39 (2.6%) | ||
| URETERAL NECROSIS | 0/35 (0%) | 1/39 (2.6%) | ||
| URETERIC STENOSIS | 1/35 (2.9%) | 1/39 (2.6%) | ||
| URINARY INCONTINENCE | 0/35 (0%) | 1/39 (2.6%) | ||
| URINARY RETENTION | 1/35 (2.9%) | 0/39 (0%) | ||
| URINARY TRACT DISORDER | 1/35 (2.9%) | 0/39 (0%) | ||
| URINARY TRACT OBSTRUCTION | 0/35 (0%) | 1/39 (2.6%) | ||
| URINOMA | 1/35 (2.9%) | 0/39 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| PULMONARY EMBOLISM | 1/35 (2.9%) | 0/39 (0%) | ||
| SLEEP APNOEA SYNDROME | 1/35 (2.9%) | 0/39 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| SKIN ULCER | 1/35 (2.9%) | 0/39 (0%) | ||
| Vascular disorders | ||||
| VARICOSE VEIN | 0/35 (0%) | 1/39 (2.6%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Tacrolimus Hexal | Prograf | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/35 (97.1%) | 38/39 (97.4%) | ||
| Blood and lymphatic system disorders | ||||
| ANAEMIA | 4/35 (11.4%) | 7/39 (17.9%) | ||
| LEUKOCYTOSIS | 0/35 (0%) | 2/39 (5.1%) | ||
| LEUKOPENIA | 3/35 (8.6%) | 7/39 (17.9%) | ||
| NEPHROGENIC ANAEMIA | 5/35 (14.3%) | 2/39 (5.1%) | ||
| Cardiac disorders | ||||
| SINUS TACHYCARDIA | 1/35 (2.9%) | 2/39 (5.1%) | ||
| Gastrointestinal disorders | ||||
| ABDOMINAL PAIN | 0/35 (0%) | 2/39 (5.1%) | ||
| ABDOMINAL PAIN UPPER | 0/35 (0%) | 2/39 (5.1%) | ||
| CONSTIPATION | 2/35 (5.7%) | 6/39 (15.4%) | ||
| DIARRHOEA | 5/35 (14.3%) | 5/39 (12.8%) | ||
| FLATULENCE | 3/35 (8.6%) | 4/39 (10.3%) | ||
| HIATUS HERNIA | 1/35 (2.9%) | 3/39 (7.7%) | ||
| NAUSEA | 2/35 (5.7%) | 5/39 (12.8%) | ||
| VOMITING | 1/35 (2.9%) | 3/39 (7.7%) | ||
| General disorders | ||||
| IMPAIRED HEALING | 1/35 (2.9%) | 2/39 (5.1%) | ||
| OEDEMA PERIPHERAL | 3/35 (8.6%) | 7/39 (17.9%) | ||
| PYREXIA | 1/35 (2.9%) | 3/39 (7.7%) | ||
| Immune system disorders | ||||
| KIDNEY TRANSPLANT REJECTION | 1/35 (2.9%) | 4/39 (10.3%) | ||
| Infections and infestations | ||||
| CYTOMEGALOVIRUS INFECTION | 1/35 (2.9%) | 4/39 (10.3%) | ||
| CYTOMEGALOVIRUS VIRAEMIA | 2/35 (5.7%) | 0/39 (0%) | ||
| NASOPHARYNGITIS | 2/35 (5.7%) | 3/39 (7.7%) | ||
| PNEUMONIA | 0/35 (0%) | 2/39 (5.1%) | ||
| SEPSIS | 0/35 (0%) | 2/39 (5.1%) | ||
| UPPER RESPIRATORY TRACT INFECTION | 2/35 (5.7%) | 1/39 (2.6%) | ||
| URINARY TRACT INFECTION | 6/35 (17.1%) | 16/39 (41%) | ||
| WOUND INFECTION | 0/35 (0%) | 2/39 (5.1%) | ||
| Injury, poisoning and procedural complications | ||||
| COMPLICATIONS OF TRANSPLANTED KIDNEY | 5/35 (14.3%) | 11/39 (28.2%) | ||
| POST PROCEDURAL HAEMATOMA | 2/35 (5.7%) | 3/39 (7.7%) | ||
| PROCEDURAL PAIN | 2/35 (5.7%) | 1/39 (2.6%) | ||
| RENAL LYMPHOCELE | 4/35 (11.4%) | 3/39 (7.7%) | ||
| WOUND COMPLICATION | 16/35 (45.7%) | 19/39 (48.7%) | ||
| WOUND DEHISCENCE | 2/35 (5.7%) | 1/39 (2.6%) | ||
| Investigations | ||||
| BLOOD CREATININE INCREASED | 2/35 (5.7%) | 6/39 (15.4%) | ||
| C-REACTIVE PROTEIN INCREASED | 0/35 (0%) | 2/39 (5.1%) | ||
| HEPATIC ENZYME INCREASED | 0/35 (0%) | 3/39 (7.7%) | ||
| Metabolism and nutrition disorders | ||||
| ACIDOSIS | 0/35 (0%) | 2/39 (5.1%) | ||
| DIABETES MELLITUS | 3/35 (8.6%) | 2/39 (5.1%) | ||
| HYPERCALCAEMIA | 1/35 (2.9%) | 2/39 (5.1%) | ||
| HYPERCHOLESTEROLAEMIA | 2/35 (5.7%) | 1/39 (2.6%) | ||
| HYPERKALAEMIA | 9/35 (25.7%) | 9/39 (23.1%) | ||
| HYPERLIPIDAEMIA | 3/35 (8.6%) | 1/39 (2.6%) | ||
| HYPERPHOSPHATAEMIA | 1/35 (2.9%) | 2/39 (5.1%) | ||
| HYPERURICAEMIA | 3/35 (8.6%) | 9/39 (23.1%) | ||
| HYPOCALCAEMIA | 5/35 (14.3%) | 4/39 (10.3%) | ||
| HYPOKALAEMIA | 5/35 (14.3%) | 4/39 (10.3%) | ||
| HYPOMAGNESAEMIA | 5/35 (14.3%) | 7/39 (17.9%) | ||
| HYPOPHOSPHATAEMIA | 3/35 (8.6%) | 2/39 (5.1%) | ||
| IRON DEFICIENCY | 0/35 (0%) | 2/39 (5.1%) | ||
| METABOLIC ACIDOSIS | 2/35 (5.7%) | 3/39 (7.7%) | ||
| VITAMIN D DEFICIENCY | 2/35 (5.7%) | 6/39 (15.4%) | ||
| Nervous system disorders | ||||
| HEADACHE | 4/35 (11.4%) | 1/39 (2.6%) | ||
| TREMOR | 3/35 (8.6%) | 2/39 (5.1%) | ||
| Psychiatric disorders | ||||
| INSOMNIA | 4/35 (11.4%) | 6/39 (15.4%) | ||
| RESTLESSNESS | 0/35 (0%) | 2/39 (5.1%) | ||
| SLEEP DISORDER | 3/35 (8.6%) | 1/39 (2.6%) | ||
| Renal and urinary disorders | ||||
| ACUTE KIDNEY INJURY | 0/35 (0%) | 2/39 (5.1%) | ||
| BLADDER PAIN | 5/35 (14.3%) | 3/39 (7.7%) | ||
| BLADDER SPASM | 0/35 (0%) | 3/39 (7.7%) | ||
| OLIGURIA | 0/35 (0%) | 2/39 (5.1%) | ||
| RENAL FAILURE | 0/35 (0%) | 2/39 (5.1%) | ||
| RENAL HYPERTENSION | 0/35 (0%) | 4/39 (10.3%) | ||
| URINARY RETENTION | 2/35 (5.7%) | 1/39 (2.6%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| DYSPNOEA | 0/35 (0%) | 2/39 (5.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| ACNE | 2/35 (5.7%) | 0/39 (0%) | ||
| ALOPECIA | 0/35 (0%) | 2/39 (5.1%) | ||
| SCAR PAIN | 0/35 (0%) | 2/39 (5.1%) | ||
| Vascular disorders | ||||
| HYPERTENSION | 12/35 (34.3%) | 20/39 (51.3%) | ||
Limitations/Caveats
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
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceuticals |
| Phone | (862) 778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01649427
Other Study ID Numbers:
- CERL080ADE27
First Posted:
Jul 25, 2012
Last Update Posted:
Jun 17, 2019
Last Verified:
Nov 1, 2017