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A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients (Tacrolimus ER)

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: NCT02444143
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Patricia West-Thielke, University of Illinois at Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Transplantation
Intervention Drug: tacrolimus extended release
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ideal Body Weight- Tacrolimus Extended Release Adjusted Body Weight-Tacrolimus Extended Release
Hide Arm/Group Description tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on Ideal Body Weight (IBW) tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on adjusted Body Weight (aBW)
Period Title: Overall Study
Started 10 10
Completed 10 9 [1]
Not Completed 0 1
[1]
1 patient withdrawal
Arm/Group Title Ideal Body Weight- Tacrolimus Extended Release Adjusted Body Weight-Tacrolimus Extended Release Total
Hide Arm/Group Description tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on Ideal Body Weight (IBW) tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on adjusted Body Weight (aBW) Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
60.3  (8.6) 47.7  (14.3) 54  (11.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
3
  30.0%
1
  10.0%
4
  20.0%
Male
7
  70.0%
9
  90.0%
16
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Hispanic or Latino
0
   0.0%
3
  30.0%
3
  15.0%
Not Hispanic or Latino
10
 100.0%
7
  70.0%
17
  85.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  30.0%
5
  50.0%
8
  40.0%
White
7
  70.0%
2
  20.0%
9
  45.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
3
  30.0%
3
  15.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
Body Mass Index greater than or equal to 30 on Post Operative Day 0  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
10
 100.0%
10
 100.0%
20
 100.0%
Donor Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Deceased
2
  20.0%
3
  30.0%
5
  25.0%
Living-unrelated
2
  20.0%
5
  50.0%
7
  35.0%
Living-related
6
  60.0%
2
  20.0%
8
  40.0%
Duration of Pre-transplant dialysis  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 10 participants 10 participants 20 participants
45.8  (36.6) 55.8  (46.8) 50.8  (41.7)
Cause of End Stage Renal Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
hypertension (HTN)
3
  30.0%
4
  40.0%
7
  35.0%
diabetes mellitus (DM)
2
  20.0%
0
   0.0%
2
  10.0%
DM + HTN
4
  40.0%
3
  30.0%
7
  35.0%
Other
1
  10.0%
3
  30.0%
4
  20.0%
Hospital stay in days  
Median (Full Range)
Unit of measure:  Days
Number Analyzed 10 participants 10 participants 20 participants
7
(6 to 21)
6.5
(5 to 17)
6.75
(5.5 to 19)
Body Mass Index at Transplant  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 10 participants 10 participants 20 participants
38.2  (5.2) 43.4  (6.8) 40.8  (6)
Weight at Transplant  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 10 participants 10 participants 20 participants
116.8  (30.2) 136.4  (30.5) 126.6  (30.35)
Ideal Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 10 participants 10 participants 20 participants
68  (13.3) 71.5  (11.8) 69.75  (12.55)
Adjusted Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 10 participants 10 participants 20 participants
86.7  (19.5) 97.5  (17.9) 92.1  (18.7)
1.Primary Outcome
Title Difference in Tacrolimus Exposure (AUC-0-24)) in Obese Patients Who Received an Initial TAC -ER Dose of 0.15 mg/kg Using aBW Versus IBW
Hide Description Difference in tacrolimus exposure (area under the concentration-time curve from time 0 to 24 hours (AUC-0-24)) in obese patients who received an initial TAC -ER dose of 0.15 mg/kg using aBW versus IBW
Time Frame Days 1-14
Hide Outcome Measure Data
Hide Analysis Population Description
This study randomized de novo kidney transplant recipients who were at least 18 years of age and obese as evidenced by a BMI ≥ 30 on the day of transplantation.
Arm/Group Title Ideal Body Weight- Tacrolimus Extended Release Adjusted Body Weight-Tacrolimus Extended Release
Hide Arm/Group Description:
tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on Ideal Body Weight (IBW)
tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on adjusted Body Weight (aBW)
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: ng•h/mL
day 1 AUC 0-24 115.2  (51.3) 90.0  (51.2)
day 7 AUC 0-24 268.3  (59.9) 269.3  (101.1)
day 14 AUC 0-24 355.0  (75.4) 267.3  (101.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ideal Body Weight- Tacrolimus Extended Release, Adjusted Body Weight-Tacrolimus Extended Release
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Difference in Time to Therapeutic Level
Hide Description Difference in the time to a therapeutic tacrolimus trough level in the aBW group compared to the IBW group.
Time Frame Days 1 to 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ideal Body Weight Adjusted Body Weight
Hide Arm/Group Description:
Astagraf 0.15 mg/kg/day based on ideal body weight (IBW)
Astagraf 0.15 mg/kg/day based on adjusted body weight (aBW)
Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: days
4.9  (3.1) 5.1  (4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ideal Body Weight, Adjusted Body Weight
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 1 year 6 months
Adverse Event Reporting Description The definition of adverse event and/or serious adverse event, used to collect adverse event information is the same from clinicaltrials.gov.
 
Arm/Group Title Ideal Body Weight- Tacrolimus Extended Release Adjusted Body Weight-Tacrolimus Extended Release
Hide Arm/Group Description tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on Ideal Body Weight (IBW) tacrolimus extended release (Astagraf) 0.15 mg/kg/day based on adjusted Body Weight (aBW)
All-Cause Mortality
Ideal Body Weight- Tacrolimus Extended Release Adjusted Body Weight-Tacrolimus Extended Release
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
Ideal Body Weight- Tacrolimus Extended Release Adjusted Body Weight-Tacrolimus Extended Release
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ideal Body Weight- Tacrolimus Extended Release Adjusted Body Weight-Tacrolimus Extended Release
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      10/10 (100.00%)    
Cardiac disorders     
Edema   2/10 (20.00%)  2 2/10 (20.00%)  2
Hypertension   1/10 (10.00%)  1 0/10 (0.00%)  0
Hypotension   2/10 (20.00%)  2 1/10 (10.00%)  1
Endocrine disorders     
Hyperglycemia   2/10 (20.00%)  2 0/10 (0.00%)  0
Gastrointestinal disorders     
Gastroparesis   0/10 (0.00%)  0 3/10 (30.00%)  3
Vomiting   2/10 (20.00%)  2 1/10 (10.00%)  1
Diarrhea   4/10 (40.00%)  4 4/10 (40.00%)  4
Nausea   3/10 (30.00%)  3 3/10 (30.00%)  3
Constipation   1/10 (10.00%)  1 0/10 (0.00%)  0
Metabolism and nutrition disorders     
Hypophosphatemia   5/10 (50.00%)  5 5/10 (50.00%)  5
Hypomagnesemia   6/10 (60.00%)  6 6/10 (60.00%)  6
Hyperkalemia   1/10 (10.00%)  1 6/10 (60.00%)  6
Hyperphosphatemia   0/10 (0.00%)  0 2/10 (20.00%)  2
Hypokalemia   1/10 (10.00%)  1 2/10 (20.00%)  2
Acidosis   1/10 (10.00%)  1 2/10 (20.00%)  2
Musculoskeletal and connective tissue disorders     
Bladder spasm   1/10 (10.00%)  1 1/10 (10.00%)  1
Tremor   0/10 (0.00%)  0 1/10 (10.00%)  1
Renal and urinary disorders     
Microalbuminuria   0/10 (0.00%)  0 1/10 (10.00%)  1
Hematuria   2/10 (20.00%)  2 1/10 (10.00%)  1
Urinary retention   1/10 (10.00%)  1 1/10 (10.00%)  1
Acute kidney injury   0/10 (0.00%)  0 1/10 (10.00%)  1
Delayed graft function   2/10 (20.00%)  2 1/10 (10.00%)  1
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: Dr. Patricia West-Thielke
Organization: University of Illinois at Chicago
Phone: 312-996-5695
EMail: pwest@uic.edu
Layout table for additonal information
Responsible Party: Patricia West-Thielke, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02444143    
Other Study ID Numbers: 2014-XXXX
First Submitted: November 20, 2014
First Posted: May 14, 2015
Results First Submitted: May 18, 2018
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018