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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

Brief Summary:
Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day dosing regimen. This formulation has the potential to improve compliance. Current dosing recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day administered once daily in the morning. There are no specifications on appropriate dosing in obese patients or on whether to use actual, ideal or and adjusted weight. It will be advantageous to understand the pharmacokinetics of this medication in the obese to determine the appropriate dosing regimen. In this study, obese patients will be randomized to receive tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or adjusted body weight (aBW).

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: tacrolimus extended release Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients
Study Start Date : May 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : June 9, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: IBW
tacrolimus extended release 0.15 mg/kg/day based on Ideal Body Weight (IBW)
Drug: tacrolimus extended release
Other Name: Astagraf XL

Experimental: ABW
tacrolimus extended release 0.15 mg/kg/day based on adjusted Body Weight (aBW)
Drug: tacrolimus extended release
Other Name: Astagraf XL




Primary Outcome Measures :
  1. 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 [ Time Frame: Days 1-14 ]
    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


Secondary Outcome Measures :
  1. Difference in Time to Therapeutic Level [ Time Frame: Days 1 to 7 ]
    Difference in the time to a therapeutic tacrolimus trough level in the aBW group compared to the IBW group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject is a recipient of a living donor or deceased donor kidney only transplant
  2. Subject is > 18 years of age
  3. BMI≥30 on POD 0

Exclusion Criteria:

  1. Multi-organ transplant
  2. Subjects taking tacrolimus pre-transplant (i.e. positive crossmatch transplants or re-transplants)
  3. Patients undergoing simultaneous sleeve gastrectomy at the time of transplant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444143


Locations
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United States, Illinois
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Astellas Pharma US, Inc.
  Study Documents (Full-Text)

Documents provided by Patricia West-Thielke, University of Illinois at Chicago:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patricia West-Thielke, Director of Clinical Research, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02444143    
Other Study ID Numbers: 2014-XXXX
First Posted: May 14, 2015    Key Record Dates
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018
Last Verified: November 2018
Keywords provided by Patricia West-Thielke, University of Illinois at Chicago:
Kidney
Immunosuppression
Transplant
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action