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Trial record 89 of 102 for:    Valcyte

Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation

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ClinicalTrials.gov Identifier: NCT00141037
Recruitment Status : Completed
First Posted : September 1, 2005
Results First Posted : July 11, 2013
Last Update Posted : November 29, 2016
Sponsor:
Collaborators:
Astellas Pharma Inc
Hoffmann-La Roche
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kidney Diseases
Kidney Transplantation
Kidney Transplant
Renal Transplantation
Renal Transplant
Interventions Drug: Daclizumab
Drug: Mycophenolate mofetil (MMF)
Drug: Prednisone
Drug: Tacrolimus
Drug: Ganciclovir
Drug: Valganciclovir
Drug: Trimethoprim and sulfamethoxazole
Enrollment 130
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Steroid-Free Immunosuppression Steroid-Based Immunosuppression
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 60 70
Completed 50 [1] 52 [2]
Not Completed 10 18
Reason Not Completed
Physician Decision             1             2
Lost to Follow-up             3             1
Protocol Violation             0             2
Withdrawal by Subject             2             1
Other             0             1
Moved from area             1             7
Graft Failure             3             4
[1]
16 subjects had reduced follow-up
[2]
8 subjects had reduced follow-up
Arm/Group Title Steroid-Free Immunosuppression Steroid-Based Immunosuppression Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 60 70 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 70 participants 130 participants
11.8  (5.4) 11.9  (6.1) 11.9  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 70 participants 130 participants
Female
20
  33.3%
28
  40.0%
48
  36.9%
Male
40
  66.7%
42
  60.0%
82
  63.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 70 participants 130 participants
60 70 130
1.Primary Outcome
Title The Difference in Linear Growth by Treatment Assignment at 1 Year Post Kidney Transplantation
Hide Description 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
Time Frame One year post kidney transplantation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All Enrolled Subjects
Arm/Group Title Steroid-Free Immunosuppression Steroid-Based Immunosuppression
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 60 70
Mean (Standard Deviation)
Unit of Measure: Standard Deviation Score (SDS)
0.37  (0.76) 0.35  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Steroid-Free Immunosuppression, Steroid-Based Immunosuppression
Comments The endpoint is assessed using a Wilcoxon nonparametric test and missing values are imputed using the last observation carried forward.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Wilcoxon Nonparametric Test
Comments [Not Specified]
2.Primary Outcome
Title Comparison by Treatment Assignment in the Number of Biopsy-Proven Acute Rejections Within 12 Months Post Kidney Transplantation
Hide Description

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
Time Frame Up to one year post kidney transplantation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
All Enrolled Subjects
Arm/Group Title Steroid-Free Immunosuppression Steroid-Based Immunosuppression
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 60 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Rejection Events
18
(17.85 to 43.21)
19
(17.20 to 39.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Steroid-Free Immunosuppression, Steroid-Based Immunosuppression
Comments The difference was analyzed using a Fisher’s exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Renal (Kidney) transplantation through end of study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Steroid-Based Immunosuppression Steroid-Free Immunosuppression
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Steroid-Based Immunosuppression Steroid-Free Immunosuppression
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Steroid-Based Immunosuppression Steroid-Free Immunosuppression
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/70 (85.71%)      52/60 (86.67%)    
Blood and lymphatic system disorders     
Anaemia  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Febrile neutropenia  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Leukocytosis  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Neutropenia  1  2/70 (2.86%)  2 0/60 (0.00%)  0
Cardiac disorders     
Atrioventricular block  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Cardiac disorder  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Pericardial effusion  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Pericarditis  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Congenital, familial and genetic disorders     
Congenital nephrotic syndrome  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Aphthous stomatitis  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Ascites  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Colitis  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Constipation  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Diarrhoea  1  3/70 (4.29%)  3 3/60 (5.00%)  4
Faecaloma  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Gastric outlet obstruction  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Gastro-intestinal fistula  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Gastrointestinal necrosis  1  1/70 (1.43%)  2 0/60 (0.00%)  0
Intestinal obstruction  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Mouth ulceration  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Peritoneal haemorrhage  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Peritonitis  1  2/70 (2.86%)  3 0/60 (0.00%)  0
Small intestinal obstruction  1  1/70 (1.43%)  1 1/60 (1.67%)  1
General disorders     
Adverse drug reaction  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Difficulty in walking  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Pyrexia  1  6/70 (8.57%)  6 12/60 (20.00%)  17
Immune system disorders     
Graft loss  1  3/70 (4.29%)  3 0/60 (0.00%)  0
Kidney transplant rejection  1  26/70 (37.14%)  39 18/60 (30.00%)  32
Transplant rejection  1  9/70 (12.86%)  12 6/60 (10.00%)  6
Infections and infestations     
Abdominal abscess  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Adenovirus infection  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Application site abscess  1  0/70 (0.00%)  0 1/60 (1.67%)  1
BK virus infection  1  2/70 (2.86%)  4 0/60 (0.00%)  0
Bacteraemia  1  1/70 (1.43%)  1 1/60 (1.67%)  1
Bacterial pyelonephritis  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Bronchiolitis  1  1/70 (1.43%)  2 0/60 (0.00%)  0
Bronchitis  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Cellulitis  1  1/70 (1.43%)  1 2/60 (3.33%)  2
Central line infection  1  0/70 (0.00%)  0 1/60 (1.67%)  3
Clostridial infection  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Clostridium colitis  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Cytomegalovirus hepatitis  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Cytomegalovirus infection  1  3/70 (4.29%)  3 1/60 (1.67%)  1
Cytomegalovirus viraemia  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Empyema  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Encephalitis viral  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Epstein-Barr virus infection  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Febrile infection  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Fungaemia  1  2/70 (2.86%)  3 0/60 (0.00%)  0
Gastroenteritis  1  8/70 (11.43%)  8 3/60 (5.00%)  3
Gastroenteritis rotavirus  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Herpes simplex  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Herpes zoster  1  2/70 (2.86%)  2 1/60 (1.67%)  1
Infectious mononucleosis  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Influenza  1  1/70 (1.43%)  1 1/60 (1.67%)  1
Kidney infection  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Pharyngitis  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Pneumonia  1  4/70 (5.71%)  6 3/60 (5.00%)  4
Pneumonia mycoplasmal  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Pneumonia primary atypical  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Pseudomonal bacteraemia  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Pyelonephritis  1  8/70 (11.43%)  11 7/60 (11.67%)  10
Pyelonephritis acute  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Sepsis  1  0/70 (0.00%)  0 2/60 (3.33%)  2
Upper respiratory tract infection  1  3/70 (4.29%)  3 2/60 (3.33%)  2
Urinary tract infection  1  7/70 (10.00%)  11 7/60 (11.67%)  7
Urosepsis  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Viral infection  1  1/70 (1.43%)  1 3/60 (5.00%)  3
Injury, poisoning and procedural complications     
Ankle fracture  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Collapse of lung  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Complications of transplanted kidney  1  3/70 (4.29%)  3 3/60 (5.00%)  3
Graft dysfunction  1  0/70 (0.00%)  0 2/60 (3.33%)  3
Post procedural complication  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Post procedural haemorrhage  1  2/70 (2.86%)  3 1/60 (1.67%)  1
Postoperative ileus  1  0/70 (0.00%)  0 2/60 (3.33%)  2
Procedural complication  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Procedural hypotension  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Road traffic accident  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Treatment noncompliance  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Investigations     
Activated partial thromboplastin time prolonged  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Blood creatinine increased  1  14/70 (20.00%)  23 20/60 (33.33%)  41
Blood potassium increased  1  2/70 (2.86%)  2 0/60 (0.00%)  0
Blood pressure increased  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Cytomegalovirus antibody positive  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Cytomegalovirus test positive  1  2/70 (2.86%)  2 1/60 (1.67%)  1
Drug level below therapeutic  1  2/70 (2.86%)  2 1/60 (1.67%)  1
Urine output decreased  1  2/70 (2.86%)  3 0/60 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Dehydration  1  7/70 (10.00%)  7 3/60 (5.00%)  4
Diabetes mellitus  1  3/70 (4.29%)  3 0/60 (0.00%)  0
Fluid overload  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Hypercalcaemia  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Hyperkalaemia  1  2/70 (2.86%)  2 3/60 (5.00%)  3
Musculoskeletal and connective tissue disorders     
Neck mass  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Lymphoproliferative disorder  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Nervous system disorders     
Convulsion  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Encephalitis  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Headache  1  1/70 (1.43%)  1 2/60 (3.33%)  2
Psychiatric disorders     
Schizophrenia  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Renal and urinary disorders     
Calculus urinary  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Glomerulonephritis focal  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Glomerulonephritis membranoproliferative  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Haematuria  1  2/70 (2.86%)  2 2/60 (3.33%)  2
Hydronephrosis  1  1/70 (1.43%)  1 2/60 (3.33%)  4
Neurogenic bladder  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Obstructive uropathy  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Oliguria  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Pelvi-ureteric obstruction  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Renal artery stenosis  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Renal failure acute  1  1/70 (1.43%)  1 1/60 (1.67%)  1
Renal impairment  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Renal tubular necrosis  1  2/70 (2.86%)  2 1/60 (1.67%)  1
Ureteric obstruction  1  1/70 (1.43%)  2 1/60 (1.67%)  3
Ureteric stenosis  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Urethral obstruction  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Urinary bladder haemorrhage  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Vesicoureteric reflux  1  2/70 (2.86%)  2 1/60 (1.67%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  1  1/70 (1.43%)  2 0/60 (0.00%)  0
Pleural effusion  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Pneumonia aspiration  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Pneumothorax  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Pulmonary oedema  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Respiratory disorder  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Respiratory distress  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Sleep apnoea syndrome  1  1/70 (1.43%)  1 2/60 (3.33%)  2
Stridor  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Tonsillar hypertrophy  1  1/70 (1.43%)  1 2/60 (3.33%)  2
Skin and subcutaneous tissue disorders     
Rash  1  1/70 (1.43%)  1 1/60 (1.67%)  1
Social circumstances     
Exposure to communicable disease  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Social problem  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Surgical and medical procedures     
Stent removal  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Vascular disorders     
Air embolism  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Arterial thrombosis  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Arteriovenous fistula  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Deep vein thrombosis  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Hypertension  1  3/70 (4.29%)  5 1/60 (1.67%)  1
Hypertensive emergency  1  0/70 (0.00%)  0 1/60 (1.67%)  2
Hypotension  1  0/70 (0.00%)  0 1/60 (1.67%)  1
Lymphocele  1  1/70 (1.43%)  1 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Steroid-Based Immunosuppression Steroid-Free Immunosuppression
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   64/70 (91.43%)      56/60 (93.33%)    
Blood and lymphatic system disorders     
Anaemia  1  21/70 (30.00%)  21 25/60 (41.67%)  31
Leukopenia  1  12/70 (17.14%)  22 14/60 (23.33%)  31
Neutropenia  1  21/70 (30.00%)  27 24/60 (40.00%)  38
Gastrointestinal disorders     
Diarrhoea  1  19/70 (27.14%)  31 18/60 (30.00%)  26
Nausea  1  5/70 (7.14%)  6 6/60 (10.00%)  6
Vomiting  1  8/70 (11.43%)  12 11/60 (18.33%)  16
General disorders     
Pyrexia  1  8/70 (11.43%)  14 13/60 (21.67%)  17
Infections and infestations     
BK virus infection  1  3/70 (4.29%)  4 4/60 (6.67%)  6
Cytomegalovirus infection  1  6/70 (8.57%)  7 8/60 (13.33%)  8
Ear infection  1  4/70 (5.71%)  8 6/60 (10.00%)  7
Epstein-Barr virus infection  1  4/70 (5.71%)  5 6/60 (10.00%)  7
Gastroenteritis  1  5/70 (7.14%)  5 5/60 (8.33%)  6
Otitis media  1  8/70 (11.43%)  9 9/60 (15.00%)  16
Sinusitis  1  8/70 (11.43%)  14 5/60 (8.33%)  8
Upper respiratory tract infection  1  10/70 (14.29%)  19 20/60 (33.33%)  28
Urinary tract infection  1  20/70 (28.57%)  32 14/60 (23.33%)  20
Injury, poisoning and procedural complications     
Incision site complication  1  5/70 (7.14%)  5 2/60 (3.33%)  2
Investigations     
Blood bicarbonate decreased  1  4/70 (5.71%)  6 3/60 (5.00%)  3
Blood creatinine increased  1  6/70 (8.57%)  10 11/60 (18.33%)  16
Blood pressure increased  1  2/70 (2.86%)  2 6/60 (10.00%)  7
Metabolism and nutrition disorders     
Hyperkalaemia  1  10/70 (14.29%)  20 12/60 (20.00%)  19
Hypomagnesaemia  1  6/70 (8.57%)  7 6/60 (10.00%)  6
Hyponatraemia  1  3/70 (4.29%)  3 4/60 (6.67%)  6
Hypophosphataemia  1  12/70 (17.14%)  12 10/60 (16.67%)  11
Metabolic acidosis  1  3/70 (4.29%)  3 5/60 (8.33%)  5
Nervous system disorders     
Headache  1  7/70 (10.00%)  8 5/60 (8.33%)  7
Respiratory, thoracic and mediastinal disorders     
Cough  1  9/70 (12.86%)  10 9/60 (15.00%)  10
Nasal congestion  1  2/70 (2.86%)  2 6/60 (10.00%)  7
Pharyngolaryngeal pain  1  5/70 (7.14%)  8 4/60 (6.67%)  4
Rhinorrhoea  1  6/70 (8.57%)  7 3/60 (5.00%)  3
Vascular disorders     
Hypertension  1  19/70 (27.14%)  20 14/60 (23.33%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
  1. The results cannot be generalized and daclizumab has since been withdrawn from the United States market (business-related, not due to any safety issues).
  2. The study was not powered to definitively evaluate small differences in rejection rate.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Director, Clinical Research Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00141037     History of Changes
Other Study ID Numbers: DAIT SNS01
First Submitted: August 1, 2005
First Posted: September 1, 2005
Results First Submitted: May 21, 2013
Results First Posted: July 11, 2013
Last Update Posted: November 29, 2016