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Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240994
Recruitment Status : Completed
First Posted : October 18, 2005
Results First Posted : October 25, 2012
Last Update Posted : January 2, 2017
Sponsor:
Collaborator:
Cooperative Clinical Trials in Pediatric Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Kidney Failure, Chronic
Kidney Transplantation
Immunosuppression
Interventions Drug: Alemtuzumab
Drug: Tacrolimus
Drug: Mycophenolate mofetil
Drug: Sirolimus
Enrollment 35
Recruitment Details Four centers in the United States recruited 35 subjects between January 2005 and October 2007 who were less than 21 years of age and first time living-donor kidney allograft recipients.
Pre-assignment Details At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form.
Arm/Group Title Alemtuzumab (Campath)
Hide Arm/Group Description In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
Period Title: Overall Study
Started 35
Completed 32
Not Completed 3
Reason Not Completed
Lost to Follow-up             1
Protocol Violation             1
Graft failure             1
Arm/Group Title Alemtuzumab (Campath)
Hide Arm/Group Description In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
Final status: Completed (N=22) 13.1  (5.0)
Final status: Discontinued Therapy (N=10) 9.8  (6.2)
Final status: Discontinued Study (N=3) 17.7  (2.4)
All Participants (N=35) 12.6  (5.5)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
20
  57.1%
Male
15
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants
35
1.Primary Outcome
Title The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation
Hide Description Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.
Time Frame Up to one year post kidney transplantation procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Alemtuzumab (Campath)
Hide Arm/Group Description:
In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: Proportion of participants
0.057
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alemtuzumab (Campath)
Comments The proportion of participants with graft loss or death within 12 months post kidney transplantation is descriptively summarized with a 95% confidence interval using an exact binomial method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% Confidence Interval
Comments 95% CI using an exact binomial method
Method of Estimation Estimation Parameter Proportion with graft loss or death
Estimated Value .057
Confidence Interval (2-Sided) 95%
0.007 to 0.192
Estimation Comments [Not Specified]
Time Frame From beginning of study to end of study
Adverse Event Reporting Description This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
 
Arm/Group Title Alemtuzumab (Campath)
Hide Arm/Group Description In this open-label, single-arm trial , participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
All-Cause Mortality
Alemtuzumab (Campath)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Alemtuzumab (Campath)
Affected / at Risk (%) # Events
Total   25/35 (71.43%)    
Blood and lymphatic system disorders   
Anaemia  1  1/35 (2.86%)  1
Leukopenia  1  1/35 (2.86%)  1
Neutropenia  1  4/35 (11.43%)  4
Thrombotic microangiopathy  1  1/35 (2.86%)  1
Gastrointestinal disorders   
Abdominal compartment syndrome  1  1/35 (2.86%)  1
Abdominal pain  1  1/35 (2.86%)  1
Ascites  1  1/35 (2.86%)  2
Diarrhoea  1  4/35 (11.43%)  4
Mouth ulceration  1  1/35 (2.86%)  1
General disorders   
Adverse drug reaction  1  1/35 (2.86%)  1
Oedema  1  1/35 (2.86%)  1
Pyrexia  1  5/35 (14.29%)  5
Immune system disorders   
Graft loss  1  2/35 (5.71%)  2
Hypersensitivity  1  1/35 (2.86%)  1
Kidney transplant rejection  1  2/35 (5.71%)  2
Transplant rejection  1  3/35 (8.57%)  4
Infections and infestations   
Adenovirus infection  1  1/35 (2.86%)  1
Arthritis bacterial  1  1/35 (2.86%)  1
Bacterial pyelonephritis  1  1/35 (2.86%)  1
Catheter site cellulitis  1  1/35 (2.86%)  1
Cellulitis  1  1/35 (2.86%)  1
Central line infection  1  1/35 (2.86%)  1
Gastroenteritis  1  3/35 (8.57%)  4
Herpes simplex  1  1/35 (2.86%)  2
Influenza  1  1/35 (2.86%)  1
Klebsiella infection  1  1/35 (2.86%)  1
Lobar pneumonia  1  1/35 (2.86%)  1
Pneumonia  1  2/35 (5.71%)  2
Pyelonephritis  1  2/35 (5.71%)  3
Rhinovirus infection  1  1/35 (2.86%)  1
Urinary tract infection  1  1/35 (2.86%)  2
Injury, poisoning and procedural complications   
Arteriovenous fistula occlusion  1  1/35 (2.86%)  1
Arteriovenous fistula thrombosis  1  1/35 (2.86%)  1
Post procedural haemorrhage  1  1/35 (2.86%)  1
Investigations   
Blood creatinine increased  1  4/35 (11.43%)  6
Blood culture positive  1  1/35 (2.86%)  1
Metabolism and nutrition disorders   
Dehydration  1  2/35 (5.71%)  2
Hypervolaemia  1  1/35 (2.86%)  1
Musculoskeletal and connective tissue disorders   
Epiphyseal disorder  1  1/35 (2.86%)  1
Tenosynovitis  1  1/35 (2.86%)  1
Nervous system disorders   
Grand mal convulsion  1  1/35 (2.86%)  1
Psychiatric disorders   
Depressed mood  1  1/35 (2.86%)  1
Renal and urinary disorders   
Anuria  1  1/35 (2.86%)  1
Glomerulonephritis focal  1  1/35 (2.86%)  1
Pelvi-ureteric obstruction  1  1/35 (2.86%)  1
Proteinuria  1  1/35 (2.86%)  1
Renal failure  1  1/35 (2.86%)  1
Urinoma  1  1/35 (2.86%)  1
Reproductive system and breast disorders   
Epididymitis  1  1/35 (2.86%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma  1  1/35 (2.86%)  2
Pneumothorax  1  1/35 (2.86%)  1
Respiratory distress  1  1/35 (2.86%)  1
Skin and subcutaneous tissue disorders   
Skin disorder  1  1/35 (2.86%)  2
Skin lesion  1  1/35 (2.86%)  1
Urticaria  1  1/35 (2.86%)  1
Surgical and medical procedures   
Gastrostomy closure  1  1/35 (2.86%)  1
Suture removal  1  1/35 (2.86%)  1
Vascular disorders   
Hypotension  1  1/35 (2.86%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alemtuzumab (Campath)
Affected / at Risk (%) # Events
Total   34/35 (97.14%)    
Blood and lymphatic system disorders   
Anaemia  1  20/35 (57.14%)  35
Leukopenia  1  23/35 (65.71%)  70
Lymphopenia  1  4/35 (11.43%)  6
Neutropenia  1  14/35 (40.00%)  26
Gastrointestinal disorders   
Abdominal pain  1  4/35 (11.43%)  4
Anal ulcer  1  2/35 (5.71%)  3
Diarrhoea  1  12/35 (34.29%)  15
Mouth ulceration  1  5/35 (14.29%)  11
Nausea  1  3/35 (8.57%)  4
Stomatitis  1  2/35 (5.71%)  2
Vomiting  1  3/35 (8.57%)  3
General disorders   
Fatigue  1  2/35 (5.71%)  2
Infusion related reaction  1  4/35 (11.43%)  4
Oedema peripheral  1  3/35 (8.57%)  4
Pain  1  2/35 (5.71%)  2
Pyrexia  1  7/35 (20.00%)  9
Immune system disorders   
Cytokine release syndrome  1  3/35 (8.57%)  3
Transplant rejection  1  2/35 (5.71%)  3
Infections and infestations   
Bronchitis  1  2/35 (5.71%)  2
Bronchitis acute  1  2/35 (5.71%)  2
Cellulitis  1  2/35 (5.71%)  2
Chronic sinusitis  1  2/35 (5.71%)  2
Cystitis klebsiella  1  4/35 (11.43%)  8
Ear infection  1  2/35 (5.71%)  3
Gastroenteritis  1  2/35 (5.71%)  2
Impetigo  1  2/35 (5.71%)  2
Nasopharyngitis  1  2/35 (5.71%)  2
Otitis media  1  2/35 (5.71%)  2
Sinusitis  1  7/35 (20.00%)  10
Upper respiratory tract infection  1  3/35 (8.57%)  3
Urinary tract infection  1  5/35 (14.29%)  8
Urinary tract infection enterococcal  1  3/35 (8.57%)  6
Viraemia  1  3/35 (8.57%)  4
Injury, poisoning and procedural complications   
Anaemia postoperative  1  2/35 (5.71%)  2
Post procedural pain  1  2/35 (5.71%)  2
Investigations   
Blood cholesterol increased  1  2/35 (5.71%)  2
Blood creatine phosphokinase increased  1  3/35 (8.57%)  3
Blood creatinine increased  1  5/35 (14.29%)  7
Blood parathyroid hormone increased  1  3/35 (8.57%)  3
Blood pressure increased  1  2/35 (5.71%)  2
Epstein-Barr virus antibody positive  1  3/35 (8.57%)  3
Haematocrit decreased  1  2/35 (5.71%)  2
Haemoglobin decreased  1  5/35 (14.29%)  9
Neutrophil count decreased  1  2/35 (5.71%)  3
Transferrin saturation decreased  1  2/35 (5.71%)  2
Weight increased  1  3/35 (8.57%)  3
Metabolism and nutrition disorders   
Dehydration  1  3/35 (8.57%)  3
Food intolerance  1  2/35 (5.71%)  2
Hypercalcaemia  1  3/35 (8.57%)  3
Hypercholesterolaemia  1  2/35 (5.71%)  2
Hyperglycaemia  1  4/35 (11.43%)  5
Hyperkalaemia  1  6/35 (17.14%)  7
Hyperlipidaemia  1  8/35 (22.86%)  8
Hypertriglyceridaemia  1  3/35 (8.57%)  3
Hypoalbuminaemia  1  6/35 (17.14%)  7
Hypocalcaemia  1  3/35 (8.57%)  3
Hypokalaemia  1  5/35 (14.29%)  8
Hypomagnesaemia  1  3/35 (8.57%)  3
Hypophosphataemia  1  9/35 (25.71%)  11
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/35 (5.71%)  2
Pain in extremity  1  3/35 (8.57%)  4
Nervous system disorders   
Headache  1  2/35 (5.71%)  2
Migraine  1  2/35 (5.71%)  2
Psychiatric disorders   
Anxiety  1  3/35 (8.57%)  4
Depression  1  3/35 (8.57%)  3
Insomnia  1  2/35 (5.71%)  2
Panic attack  1  2/35 (5.71%)  2
Renal and urinary disorders   
Haematuria  1  4/35 (11.43%)  4
Hydronephrosis  1  3/35 (8.57%)  3
Hypercalciuria  1  2/35 (5.71%)  2
Proteinuria  1  5/35 (14.29%)  7
Respiratory, thoracic and mediastinal disorders   
Pharyngolaryngeal pain  1  4/35 (11.43%)  5
Skin and subcutaneous tissue disorders   
Pruritus  1  2/35 (5.71%)  2
Rash  1  2/35 (5.71%)  3
Vascular disorders   
Hypertension  1  16/35 (45.71%)  18
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
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
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Research Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00240994    
Other Study ID Numbers: DAIT PC01
First Submitted: October 14, 2005
First Posted: October 18, 2005
Results First Submitted: September 13, 2012
Results First Posted: October 25, 2012
Last Update Posted: January 2, 2017