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Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation (OPTIMAL)

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: NCT02533180
Recruitment Status : Active, not recruiting
First Posted : August 26, 2015
Results First Posted : March 5, 2021
Last Update Posted : June 11, 2021
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
PPD
Rho Federal Systems Division, Inc.
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: Treatment
Conditions Liver Transplant
Liver Transplantation
Intervention Biological: Immunosuppression withdrawal
Enrollment 100
Recruitment Details 100 participants were enrolled from 7 sites in the US between December 2015 and November 2018. 61 of the enrolled participants were eligible to initiate immunosuppression withdrawal and the remaining 39 participants were terminated (e.g., ineligible to initiate immunosuppression withdrawal) based on biopsy findings or other pre-specified criteria.
Pre-assignment Details Informed consent was obtained from potentially eligible individuals who then underwent a study-mandated biopsy to determine if they were allowed to initiate immunosuppression withdrawal based on pre-specified histological criteria.
Arm/Group Title Enrolled, Did Not Initiate Immunosuppression Withdrawal Initiated Immunosuppression Withdrawal
Hide Arm/Group Description Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol. These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
Period Title: Overall Study
Started 39 61
Completed 0 14
Not Completed 39 47
Reason Not Completed
Death             0             1
Lost to Follow-up             0             1
Physician Decision             0             1
Withdrawal by Subject             2             4
Screen Failure             37             0
Protocol Deviation             0             1
On Study             0             39
Arm/Group Title Enrolled, Did Not Initiate Immunosuppression Withdrawal Initiated Immunosuppression Withdrawal Total
Hide Arm/Group Description Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol. These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal. Total of all reporting groups
Overall Number of Baseline Participants 39 61 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 61 participants 100 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
  79.5%
37
  60.7%
68
  68.0%
>=65 years
8
  20.5%
24
  39.3%
32
  32.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 61 participants 100 participants
51.0  (15.88) 60.3  (12.07) 56.7  (14.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 61 participants 100 participants
Female
15
  38.5%
18
  29.5%
33
  33.0%
Male
24
  61.5%
43
  70.5%
67
  67.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 61 participants 100 participants
Hispanic or Latino
2
   5.1%
4
   6.6%
6
   6.0%
Not Hispanic or Latino
36
  92.3%
49
  80.3%
85
  85.0%
Unknown or Not Reported
1
   2.6%
8
  13.1%
9
   9.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 61 participants 100 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.6%
6
   9.8%
7
   7.0%
Native Hawaiian or Other Pacific Islander
1
   2.6%
1
   1.6%
2
   2.0%
Black or African American
2
   5.1%
0
   0.0%
2
   2.0%
White
33
  84.6%
50
  82.0%
83
  83.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   5.1%
4
   6.6%
6
   6.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 39 participants 61 participants 100 participants
39
 100.0%
61
 100.0%
100
 100.0%
Alanine Transaminase (ALT)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 0 participants 61 participants 61 participants
23.8  (10.7) 23.8  (10.7)
[1]
Measure Description:

The average of two ALT results taken at screening and 7 (+/- 2 days) before initiation of immunosuppression withdrawal. Only participants that initiated immunosuppression withdrawal will have both measurements.

Reference: A liver function test -Normal Value: 7- 41 U/L.

[2]
Measure Analysis Population Description: Only participants that initiated immunosuppression withdrawal will have both measurements.
Gamma-glutamyl Transferase (GGT)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 0 participants 61 participants 61 participants
34.2  (24.58) 34.2  (24.58)
[1]
Measure Description:

The average of two GGT results taken at screening and 7 (+/- 2 days) before initiation of immunosuppression withdrawal. Only participants that initiated immunosuppression withdrawal will have both measurements.

Reference: A liver function test- Normal Value: 9 - 58 U/L

[2]
Measure Analysis Population Description: Only participants that initiated immunosuppression withdrawal will have both measurements.
Time from transplant (years)   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 61 participants 100 participants
11.5  (7.99) 9.1  (5.65) 10.0  (6.73)
[1]
Measure Description: The time from transplant to study enrollment in years.
1.Primary Outcome
Title The Percent of Participants Who Achieve Operational Tolerance 52 Weeks After Completion of Immunosuppression Withdrawal.
Hide Description Participants are considered as successfully withdrawn from immunosuppression if they remain off immunosuppression for at least 52 weeks without evidence of rejection since enrollment and have a liver biopsy at 52 weeks following completion of immunosuppression withdrawal demonstrating histological stability and the absence of rejection per Banff global assessment criteria. This biopsy is assessed by the central pathologist. All participants who fail to complete immunosuppression withdrawal, regardless of reason, or fail to have a biopsy 52 weeks after completion of immunosuppression withdrawal will be considered to have failed.
Time Frame From initiation of immunosuppression withdrawal through 52 weeks after stopping all immunosuppression
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who initiated immunosuppression withdrawal
Arm/Group Title Immunosuppression Withdrawal (ISW)
Hide Arm/Group Description:
These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
Overall Number of Participants Analyzed 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of Participants
16.4
(8.15 to 28.1)
2.Secondary Outcome
Title Proportion of Participants Who Develop Donor-Specific AlloAbs (DSA) or de Novo Anti-human Leukocyte Antigen Human Leukocyte Antigen (HLA) Antibodies
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
3.Secondary Outcome
Title The Incidence of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
4.Secondary Outcome
Title The Severity of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
5.Secondary Outcome
Title The Timing of Acute Rejection, Steroid Resistant Rejection, and Chronic Rejection
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
6.Secondary Outcome
Title The Incidence of Graft Fibrosis in Tolerant Versus Non- Tolerant Patients.
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
7.Secondary Outcome
Title The Progression of Graft Fibrosis in Tolerant Versus Non- Tolerant Patients
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
8.Secondary Outcome
Title The Incidence of Graft Loss
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
9.Secondary Outcome
Title The Incidence of All-Cause Mortality
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
10.Secondary Outcome
Title The Incidence of Study-related SAEs
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Proportion of Operationally Tolerant Subjects Who Remain Free of Rejection.
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Changes in Renal Function in Tolerant Versus Non-tolerant Participants
Hide Description Changes in renal function defined as estimated GFR calculated by CKD-EPI: http://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr.
Time Frame Baseline, 1, 2 and 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Changes in Quality of Life in Tolerant Versus Non-tolerant Participants and in All Participants
Hide Description Changes in Quality of Life as measured by the NIDDK Liver Transplantation Database Quality of Life Form
Time Frame Baseline and 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Changes in SF-36 in Tolerant Versus Non-tolerant Participants and in All Participants
Hide Description [Not Specified]
Time Frame Baseline and 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Predictive Value of Time Post-transplant With Regard to Operational Tolerance
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Correlative Value of Time Post-transplant With Regard to Operational Tolerance
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Predictive Value of Recipient Age With Regard to Operational Tolerance
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Correlative Value of Recipient Age With Regard to Operational Tolerance
Hide Description [Not Specified]
Time Frame 3 years after completing immunosuppression withdrawal
Outcome Measure Data Not Reported
Time Frame Up to 156 weeks
Adverse Event Reporting Description Prior to initiating immunosuppression withdrawal, only adverse events and serious adverse events associated with protocol-mandated blood draws or the screening biopsy will be collected from study enrollment until initiation of immunosuppression withdrawal.
 
Arm/Group Title Enrolled, Did Not Initiate Immunosuppression Withdrawal Initiated Immunosuppression Withdrawal
Hide Arm/Group Description Theses participants were consented and enrolled into the study, but did not initiate immunosuppression withdrawal as specified by the protocol. These participants were enrolled into the study and initiated immunosuppression withdrawal per protocol. Participants could initiate withdrawal from calcineurin inhibitor (CNI) monotherapy or combination therapy with CNI and prednisone or CNI and a mycophenolate compound. Immunosuppression withdrawal followed a pre-specified process with the goal of achieving complete discontinuation of all immunosuppressive medication between 24 and 45 weeks after initiation of withdrawal.
All-Cause Mortality
Enrolled, Did Not Initiate Immunosuppression Withdrawal Initiated Immunosuppression Withdrawal
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      1/61 (1.64%)    
Hide Serious Adverse Events
Enrolled, Did Not Initiate Immunosuppression Withdrawal Initiated Immunosuppression Withdrawal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/39 (0.00%)      25/61 (40.98%)    
Blood and lymphatic system disorders     
Anaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Haemolytic anaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Iron deficiency anaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Normochromic normocytic anaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Cardiac disorders     
Arrhythmia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Atrial fibrillation  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Atrioventricular block  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Atrioventricular block complete  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Cardiac failure acute  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Ear and labyrinth disorders     
Vertigo  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Endocrine disorders     
Hyperthyroidism  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Eye disorders     
Diplopia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Abdominal hernia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Abdominal pain  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Abdominal pain upper  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Diarrhoea  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Gastrointestinal haemorrhage  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Intestinal ischaemia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Large intestine perforation  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Nausea  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Parotid gland enlargement  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Small intestinal obstruction  1  0/39 (0.00%)  0 3/61 (4.92%)  7
Umbilical hernia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Vomiting  1  0/39 (0.00%)  0 0/61 (0.00%)  0
General disorders     
Gait disturbance  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Incarcerated hernia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Oedema peripheral  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hepatobiliary disorders     
Bile duct stenosis  1  0/39 (0.00%)  0 1/61 (1.64%)  2
Cholelithiasis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Haemobilia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Hepatic artery stenosis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hepatic function abnormal  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Intrahepatic portal hepatic venous fistula  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Immune system disorders     
Transplant rejection  1  0/39 (0.00%)  0 5/61 (8.20%)  6
Infections and infestations     
Abdominal wall abscess  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Acute sinusitis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Bronchitis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Cellulitis  1  0/39 (0.00%)  0 2/61 (3.28%)  2
Chlamydial infection  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Conjunctivitis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Diverticulitis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Gastroenteritis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Gastroenteritis norovirus  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Gingivitis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hand-foot-and-mouth disease  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hepatitis B  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Herpes virus infection  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Herpes zoster  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Influenza  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Lyme disease  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Medical device site joint infection  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Nasopharyngitis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Pharyngitis streptococcal  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Pneumonia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Post procedural cellulitis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Pyelonephritis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Respiratory tract infection  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Rhinovirus infection  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Sinusitis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Tooth infection  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Upper respiratory tract infection  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Urinary tract infection  1  0/39 (0.00%)  0 2/61 (3.28%)  3
Viral infection  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Viral upper respiratory tract infection  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Vulvovaginal mycotic infection  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Injury, poisoning and procedural complications     
Ankle fracture  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Arthropod bite  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Concussion  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Exposure to toxic agent  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Fall  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Hand fracture  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Incisional hernia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Meniscus injury  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Post procedural discomfort  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Procedural nausea  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Procedural pain  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Rib fracture  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Synovial rupture  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Transplant dysfunction  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Aspartate aminotransferase increased  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Blood glucose increased  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Cardiac murmur  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Gamma-glutamyltransferase increased  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hepatic enzyme increased  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Laboratory test abnormal  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Liver function test abnormal  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/39 (0.00%)  0 1/61 (1.64%)  2
Fluid overload  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Gout  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hyperglycaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hyperkalaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hypoglycaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hypomagnesaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Type 2 diabetes mellitus  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Back pain  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Joint effusion  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Joint swelling  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Myalgia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Neck pain  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Osteoarthritis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Prostate cancer  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Squamous cell carcinoma  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Nervous system disorders     
Aphasia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Autonomic nervous system imbalance  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Cerebrovascular accident  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Dizziness  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Lumbar radiculopathy  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Migraine  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Presyncope  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Syncope  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Psychiatric disorders     
Mental status changes  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Renal and urinary disorders     
Chronic kidney disease  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Nephrolithiasis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Urinary retention  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Reproductive system and breast disorders     
Prostatitis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Cough  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Dyspnoea  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Sleep apnoea syndrome  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Pruritus  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Vascular disorders     
Aortic stenosis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Hypertension  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Orthostatic hypotension  1  0/39 (0.00%)  0 1/61 (1.64%)  1
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enrolled, Did Not Initiate Immunosuppression Withdrawal Initiated Immunosuppression Withdrawal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/39 (7.69%)      53/61 (86.89%)    
Blood and lymphatic system disorders     
Anaemia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Haemolytic anaemia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Iron deficiency anaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Normochromic normocytic anaemia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Cardiac disorders     
Arrhythmia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Atrial fibrillation  1  0/39 (0.00%)  0 2/61 (3.28%)  2
Atrioventricular block  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Atrioventricular block complete  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Cardiac failure acute  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Endocrine disorders     
Hyperthyroidism  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Eye disorders     
Diplopia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Gastrointestinal disorders     
Abdominal distension  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Abdominal hernia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Abdominal pain  1  1/39 (2.56%)  1 1/61 (1.64%)  1
Abdominal pain upper  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Diarrhoea  1  0/39 (0.00%)  0 3/61 (4.92%)  3
Gastrointestinal haemorrhage  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Intestinal ischaemia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Large intestine perforation  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Nausea  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Parotid gland enlargement  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Small intestinal obstruction  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Umbilical hernia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Vomiting  1  0/39 (0.00%)  0 1/61 (1.64%)  1
General disorders     
Gait disturbance  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Incarcerated hernia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Oedema peripheral  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hepatobiliary disorders     
Bile duct stenosis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Cholelithiasis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Haemobilia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hepatic artery stenosis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Hepatic function abnormal  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Intrahepatic portal hepatic venous fistula  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Immune system disorders     
Transplant rejection  1  0/39 (0.00%)  0 28/61 (45.90%)  28
Infections and infestations     
Abdominal wall abscess  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Acute sinusitis  1  0/39 (0.00%)  0 2/61 (3.28%)  2
Bronchitis  1  0/39 (0.00%)  0 3/61 (4.92%)  3
Cellulitis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Chlamydial infection  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Conjunctivitis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Diverticulitis  1  0/39 (0.00%)  0 3/61 (4.92%)  3
Gastroenteritis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Gastroenteritis norovirus  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Gingivitis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Hand-foot-and-mouth disease  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Hepatitis B  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Herpes virus infection  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Herpes zoster  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Influenza  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Lyme disease  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Medical device site joint infection  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Nasopharyngitis  1  0/39 (0.00%)  0 2/61 (3.28%)  2
Pharyngitis streptococcal  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Pneumonia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Post procedural cellulitis  1  1/39 (2.56%)  1 0/61 (0.00%)  0
Pyelonephritis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Respiratory tract infection  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Rhinovirus infection  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Sinusitis  1  0/39 (0.00%)  0 4/61 (6.56%)  4
Tooth infection  1  0/39 (0.00%)  0 3/61 (4.92%)  3
Upper respiratory tract infection  1  0/39 (0.00%)  0 6/61 (9.84%)  6
Urinary tract infection  1  0/39 (0.00%)  0 5/61 (8.20%)  6
Viral infection  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Viral upper respiratory tract infection  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Vulvovaginal mycotic infection  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Arthropod bite  1  0/39 (0.00%)  0 2/61 (3.28%)  2
Concussion  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Exposure to toxic agent  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Fall  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Hand fracture  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Incisional hernia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Meniscus injury  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Post procedural discomfort  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Procedural nausea  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Procedural pain  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Rib fracture  1  0/39 (0.00%)  0 3/61 (4.92%)  3
Synovial rupture  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Transplant dysfunction  1  0/39 (0.00%)  0 5/61 (8.20%)  6
Investigations     
Alanine aminotransferase increased  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Aspartate aminotransferase increased  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Blood glucose increased  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Cardiac murmur  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Gamma-glutamyltransferase increased  1  1/39 (2.56%)  1 5/61 (8.20%)  5
Hepatic enzyme increased  1  0/39 (0.00%)  0 2/61 (3.28%)  2
Laboratory test abnormal  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Liver function test abnormal  1  0/39 (0.00%)  0 5/61 (8.20%)  5
Metabolism and nutrition disorders     
Dehydration  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Fluid overload  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Gout  1  0/39 (0.00%)  0 2/61 (3.28%)  3
Hyperglycaemia  1  1/39 (2.56%)  1 2/61 (3.28%)  2
Hyperkalaemia  1  0/39 (0.00%)  0 1/61 (1.64%)  3
Hypoglycaemia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Hypomagnesaemia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Type 2 diabetes mellitus  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/39 (0.00%)  0 3/61 (4.92%)  3
Back pain  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Joint effusion  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Joint swelling  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Myalgia  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Neck pain  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Osteoarthritis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Prostate cancer  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Squamous cell carcinoma  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Nervous system disorders     
Aphasia  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Autonomic nervous system imbalance  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Cerebrovascular accident  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Dizziness  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Lumbar radiculopathy  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Migraine  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Presyncope  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Syncope  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Psychiatric disorders     
Mental status changes  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Renal and urinary disorders     
Chronic kidney disease  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Nephrolithiasis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Urinary retention  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Reproductive system and breast disorders     
Prostatitis  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Cough  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Dyspnoea  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Sleep apnoea syndrome  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Skin and subcutaneous tissue disorders     
Dermatitis atopic  1  0/39 (0.00%)  0 1/61 (1.64%)  2
Pruritus  1  0/39 (0.00%)  0 1/61 (1.64%)  1
Vascular disorders     
Aortic stenosis  1  0/39 (0.00%)  0 0/61 (0.00%)  0
Hypertension  1  0/39 (0.00%)  0 2/61 (3.28%)  2
Orthostatic hypotension  1  0/39 (0.00%)  0 0/61 (0.00%)  0
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
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: Director, Clinical Research Operations 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: NCT02533180    
Other Study ID Numbers: DAIT ITN056ST
First Submitted: August 21, 2015
First Posted: August 26, 2015
Results First Submitted: February 10, 2021
Results First Posted: March 5, 2021
Last Update Posted: June 11, 2021