Trial Outcomes & Findings for Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation (NCT NCT00141037)
NCT ID: NCT00141037
Last Updated: 2016-11-29
Results Overview
Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
130 participants
Primary outcome timeframe
One year post kidney transplantation procedure
Results posted on
2016-11-29
Participant Flow
Twelve pediatric kidney transplantation centers in the United States enrolled 130 subjects (less than 21 years of age) who received a primary kidney transplant from a deceased or living donor. Subject enrollment occurred between March 2004 and July 2006.
Participant milestones
| Measure |
Steroid-Free Immunosuppression
Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
Steroid-Based Immunosuppression
Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing \<40kg and 1.5 mg/kg/day in subjects weighing \>40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
70
|
|
Overall Study
COMPLETED
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
10
|
18
|
Reasons for withdrawal
| Measure |
Steroid-Free Immunosuppression
Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
Steroid-Based Immunosuppression
Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing \<40kg and 1.5 mg/kg/day in subjects weighing \>40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Other
|
0
|
1
|
|
Overall Study
Moved from area
|
1
|
7
|
|
Overall Study
Graft Failure
|
3
|
4
|
Baseline Characteristics
Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation
Baseline characteristics by cohort
| Measure |
Steroid-Free Immunosuppression
n=60 Participants
Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
Steroid-Based Immunosuppression
n=70 Participants
Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing \<40kg and 1.5 mg/kg/day in subjects weighing \>40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.8 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
11.9 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
11.9 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
70 participants
n=7 Participants
|
130 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One year post kidney transplantation procedurePopulation: All Enrolled Subjects
Standardized Z-scores were computed following a formula using an age- and gender-specific calculation provided by the NHANES III 2000 Growth Data set. The Z-score system expresses anthropometric values of height as several standard deviations (SDs) below (e.g., a negative value) or above (a positive value) the reference mean or median value. In this study the measure was used to test whether there is a difference in the change in height between the treatment groups: Steroid-Based versus Steroid-Free
Outcome measures
| Measure |
Steroid-Free Immunosuppression
n=60 Participants
Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
Steroid-Based Immunosuppression
n=70 Participants
Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing \<40kg and 1.5 mg/kg/day in subjects weighing \>40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
|---|---|---|
|
The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation
|
0.37 Standard Deviation Score (SDS)
Standard Deviation 0.76
|
0.35 Standard Deviation Score (SDS)
Standard Deviation 0.82
|
PRIMARY outcome
Timeframe: Up to one year post kidney transplantation procedurePopulation: All Enrolled Subjects
Biopsy-proven acute renal (kidney) rejection \[1, 2\]. 1. Diagnosis of acute rejection was made by renal biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection\[2\] 2. Ref: Racusen LC et al. The Banff 97 working classification of renal allograft pathology. Kidney Int, 55: 713-723, 1999
Outcome measures
| Measure |
Steroid-Free Immunosuppression
n=60 Participants
Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
Steroid-Based Immunosuppression
n=70 Participants
Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing \<40kg and 1.5 mg/kg/day in subjects weighing \>40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
|---|---|---|
|
Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation
|
18 Rejection Events
Interval 17.85 to 43.21
|
19 Rejection Events
Interval 17.2 to 39.1
|
Adverse Events
Steroid-Based Immunosuppression
Serious events: 60 serious events
Other events: 64 other events
Deaths: 0 deaths
Steroid-Free Immunosuppression
Serious events: 52 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Steroid-Based Immunosuppression
n=70 participants at risk
Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing \<40kg and 1.5 mg/kg/day in subjects weighing \>40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
Steroid-Free Immunosuppression
n=60 participants at risk
Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Cardiac disorders
Atrioventricular block
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Cardiac disorders
Cardiac disorder
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Cardiac disorders
Pericarditis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Congenital, familial and genetic disorders
Congenital nephrotic syndrome
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
3/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
5.0%
3/60 • Number of events 4 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Faecaloma
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Gastric outlet obstruction
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Gastro-intestinal fistula
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
1.4%
1/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Peritonitis
|
2.9%
2/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
General disorders
Adverse drug reaction
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
General disorders
Difficulty in walking
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
General disorders
Pyrexia
|
8.6%
6/70 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
20.0%
12/60 • Number of events 17 • Renal (Kidney) transplantation through end of study
|
|
Immune system disorders
Graft loss
|
4.3%
3/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Immune system disorders
Kidney transplant rejection
|
37.1%
26/70 • Number of events 39 • Renal (Kidney) transplantation through end of study
|
30.0%
18/60 • Number of events 32 • Renal (Kidney) transplantation through end of study
|
|
Immune system disorders
Transplant rejection
|
12.9%
9/70 • Number of events 12 • Renal (Kidney) transplantation through end of study
|
10.0%
6/60 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Abdominal abscess
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Application site abscess
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
BK virus infection
|
2.9%
2/70 • Number of events 4 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Bacteraemia
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Bronchiolitis
|
1.4%
1/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Bronchitis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Cellulitis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Central line infection
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Clostridial infection
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Clostridium colitis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Cytomegalovirus infection
|
4.3%
3/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Cytomegalovirus viraemia
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Empyema
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Febrile infection
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Fungaemia
|
2.9%
2/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Gastroenteritis
|
11.4%
8/70 • Number of events 8 • Renal (Kidney) transplantation through end of study
|
5.0%
3/60 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Gastroenteritis rotavirus
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Herpes zoster
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Infectious mononucleosis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Influenza
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Kidney infection
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Pneumonia
|
5.7%
4/70 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
5.0%
3/60 • Number of events 4 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Pneumonia mycoplasmal
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Pseudomonal bacteraemia
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Pyelonephritis
|
11.4%
8/70 • Number of events 11 • Renal (Kidney) transplantation through end of study
|
11.7%
7/60 • Number of events 10 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Sepsis
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
3/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Urinary tract infection
|
10.0%
7/70 • Number of events 11 • Renal (Kidney) transplantation through end of study
|
11.7%
7/60 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Urosepsis
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Viral infection
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
5.0%
3/60 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Collapse of lung
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
4.3%
3/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
5.0%
3/60 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Graft dysfunction
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.9%
2/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Treatment noncompliance
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Activated partial thromboplastin time prolonged
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Blood creatinine increased
|
20.0%
14/70 • Number of events 23 • Renal (Kidney) transplantation through end of study
|
33.3%
20/60 • Number of events 41 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Blood potassium increased
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Blood pressure increased
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Cytomegalovirus antibody positive
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Cytomegalovirus test positive
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Drug level below therapeutic
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Urine output decreased
|
2.9%
2/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
7/70 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
5.0%
3/60 • Number of events 4 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.3%
3/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Fluid overload
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
5.0%
3/60 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Nervous system disorders
Convulsion
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Nervous system disorders
Encephalitis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Nervous system disorders
Headache
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Psychiatric disorders
Schizophrenia
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Glomerulonephritis focal
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Glomerulonephritis membranoproliferative
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Haematuria
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Hydronephrosis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 4 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Obstructive uropathy
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Renal artery stenosis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Renal failure acute
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Renal tubular necrosis
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Ureteric obstruction
|
1.4%
1/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Ureteric stenosis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Urethral obstruction
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.4%
1/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Social circumstances
Exposure to communicable disease
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Social circumstances
Social problem
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Surgical and medical procedures
Stent removal
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Vascular disorders
Air embolism
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Vascular disorders
Arteriovenous fistula
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
|
Vascular disorders
Hypertension
|
4.3%
3/70 • Number of events 5 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Vascular disorders
Hypotension
|
0.00%
0/70 • Renal (Kidney) transplantation through end of study
|
1.7%
1/60 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
|
Vascular disorders
Lymphocele
|
1.4%
1/70 • Number of events 1 • Renal (Kidney) transplantation through end of study
|
0.00%
0/60 • Renal (Kidney) transplantation through end of study
|
Other adverse events
| Measure |
Steroid-Based Immunosuppression
n=70 participants at risk
Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing \<40kg and 1.5 mg/kg/day in subjects weighing \>40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
Steroid-Free Immunosuppression
n=60 participants at risk
Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
21/70 • Number of events 21 • Renal (Kidney) transplantation through end of study
|
41.7%
25/60 • Number of events 31 • Renal (Kidney) transplantation through end of study
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.1%
12/70 • Number of events 22 • Renal (Kidney) transplantation through end of study
|
23.3%
14/60 • Number of events 31 • Renal (Kidney) transplantation through end of study
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
21/70 • Number of events 27 • Renal (Kidney) transplantation through end of study
|
40.0%
24/60 • Number of events 38 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Diarrhoea
|
27.1%
19/70 • Number of events 31 • Renal (Kidney) transplantation through end of study
|
30.0%
18/60 • Number of events 26 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Nausea
|
7.1%
5/70 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
10.0%
6/60 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
8/70 • Number of events 12 • Renal (Kidney) transplantation through end of study
|
18.3%
11/60 • Number of events 16 • Renal (Kidney) transplantation through end of study
|
|
General disorders
Pyrexia
|
11.4%
8/70 • Number of events 14 • Renal (Kidney) transplantation through end of study
|
21.7%
13/60 • Number of events 17 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
BK virus infection
|
4.3%
3/70 • Number of events 4 • Renal (Kidney) transplantation through end of study
|
6.7%
4/60 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Cytomegalovirus infection
|
8.6%
6/70 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
13.3%
8/60 • Number of events 8 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Ear infection
|
5.7%
4/70 • Number of events 8 • Renal (Kidney) transplantation through end of study
|
10.0%
6/60 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Epstein-Barr virus infection
|
5.7%
4/70 • Number of events 5 • Renal (Kidney) transplantation through end of study
|
10.0%
6/60 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Gastroenteritis
|
7.1%
5/70 • Number of events 5 • Renal (Kidney) transplantation through end of study
|
8.3%
5/60 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Otitis media
|
11.4%
8/70 • Number of events 9 • Renal (Kidney) transplantation through end of study
|
15.0%
9/60 • Number of events 16 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Sinusitis
|
11.4%
8/70 • Number of events 14 • Renal (Kidney) transplantation through end of study
|
8.3%
5/60 • Number of events 8 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
10/70 • Number of events 19 • Renal (Kidney) transplantation through end of study
|
33.3%
20/60 • Number of events 28 • Renal (Kidney) transplantation through end of study
|
|
Infections and infestations
Urinary tract infection
|
28.6%
20/70 • Number of events 32 • Renal (Kidney) transplantation through end of study
|
23.3%
14/60 • Number of events 20 • Renal (Kidney) transplantation through end of study
|
|
Injury, poisoning and procedural complications
Incision site complication
|
7.1%
5/70 • Number of events 5 • Renal (Kidney) transplantation through end of study
|
3.3%
2/60 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Blood bicarbonate decreased
|
5.7%
4/70 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
5.0%
3/60 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Blood creatinine increased
|
8.6%
6/70 • Number of events 10 • Renal (Kidney) transplantation through end of study
|
18.3%
11/60 • Number of events 16 • Renal (Kidney) transplantation through end of study
|
|
Investigations
Blood pressure increased
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
10.0%
6/60 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
10/70 • Number of events 20 • Renal (Kidney) transplantation through end of study
|
20.0%
12/60 • Number of events 19 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.6%
6/70 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
10.0%
6/60 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.3%
3/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
6.7%
4/60 • Number of events 6 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
17.1%
12/70 • Number of events 12 • Renal (Kidney) transplantation through end of study
|
16.7%
10/60 • Number of events 11 • Renal (Kidney) transplantation through end of study
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
4.3%
3/70 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
8.3%
5/60 • Number of events 5 • Renal (Kidney) transplantation through end of study
|
|
Nervous system disorders
Headache
|
10.0%
7/70 • Number of events 8 • Renal (Kidney) transplantation through end of study
|
8.3%
5/60 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
9/70 • Number of events 10 • Renal (Kidney) transplantation through end of study
|
15.0%
9/60 • Number of events 10 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.9%
2/70 • Number of events 2 • Renal (Kidney) transplantation through end of study
|
10.0%
6/60 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
7.1%
5/70 • Number of events 8 • Renal (Kidney) transplantation through end of study
|
6.7%
4/60 • Number of events 4 • Renal (Kidney) transplantation through end of study
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.6%
6/70 • Number of events 7 • Renal (Kidney) transplantation through end of study
|
5.0%
3/60 • Number of events 3 • Renal (Kidney) transplantation through end of study
|
|
Vascular disorders
Hypertension
|
27.1%
19/70 • Number of events 20 • Renal (Kidney) transplantation through end of study
|
23.3%
14/60 • Number of events 15 • Renal (Kidney) transplantation through end of study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place