NCT02444143

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

November 7, 2018

Completed
Last Updated

November 7, 2018

Status Verified

November 1, 2018

Enrollment Period

1.8 years

First QC Date

November 20, 2014

Results QC Date

May 18, 2018

Last Update Submit

November 6, 2018

Conditions

Kidney Transplantation

Keywords

KidneyImmunosuppressionTransplant

Outcome Measures

Primary Outcomes (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

    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

    Days 1-14

Secondary Outcomes (1)

  • Difference in Time to Therapeutic Level

    Days 1 to 7

Study Arms (2)

IBW

ACTIVE COMPARATOR

tacrolimus extended release 0.15 mg/kg/day based on Ideal Body Weight (IBW)

Drug: tacrolimus extended release

ABW

EXPERIMENTAL

tacrolimus extended release 0.15 mg/kg/day based on adjusted Body Weight (aBW)

Drug: tacrolimus extended release

Interventions

tacrolimus extended releaseDRUG
Also known as: Astagraf XL
ABWIBW

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

  • Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.

    PMID: 33782940DERIVED

  • Jasiak-Panek NM, Wenzler E, Patel S, Thielke JJ, Progar K, Patel S, Brandt S, Huang YJ, Benedetti E, West-Thielke PM. A randomized, open-label pharmacokinetic trial of tacrolimus extended-release dosing in obese de novo kidney transplant recipients. Clin Transplant. 2019 Aug;33(8):e13640. doi: 10.1111/ctr.13640. Epub 2019 Jul 1.

    PMID: 31206808DERIVED

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Dr. Patricia West-Thielke
Organization
University of Illinois at Chicago
pwest@uic.edu
312-996-5695

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research

Study Record Dates

First Submitted

November 20, 2014

First Posted

May 14, 2015

Study Start

May 1, 2015

Primary Completion

February 28, 2017

Study Completion

June 9, 2017

Last Updated

November 7, 2018

Results First Posted

November 7, 2018

Record last verified: 2018-11

Locations

US(1)