NCT03760263

Brief Summary

Evaluation Dose Adjustments in Kidney Transplant Patients on Immediate Release and Extended Release Tacrolimus

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2020

Longer than P75 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 3, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

November 30, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 16, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

November 3, 2018

Last Update Submit

February 28, 2024

Conditions

Transplant;Failure,Kidney

Outcome Measures

Primary Outcomes (1)

  • I. Percentage of tacrolimus levels in range after transplantation

    Labs will be drawn at weekly clinic visits for the first month, every other week for the second month, then a minimum of monthly through 6 months post transplant. Labs drawn will include tacrolimus level to determine if trough levels are within target ranges according to the site's center specific tacrolimus protocol.

    6 Months

Secondary Outcomes (1)

  • II. Time in therapeutic range for tacrolimus trough levels during intervals after transplantation based on the Rosendaal Method

    6 Months

Study Arms (2)

Envarsus

ACTIVE COMPARATOR

Once-daily extended-release tacrolimus

Drug: Tacrolimus

Prograf

ACTIVE COMPARATOR

twice-daily tacrolimus

Drug: Tacrolimus

Interventions

TacrolimusDRUG

Immunosuppressive drug that can prevent organ rejection after transplant in its oral form.

Also known as: Envarsus
EnvarsusPrograf

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70
  • Receiving a kidney transplant at Sentara Norfolk General Hospital
  • Able to give informed consent

You may not qualify if:

  • Multi-organ transplant
  • Previous functioning transplant
  • Prior surgery to the gastrointestinal tract that alters the normal anatomy with the exception of cholecystectomy
  • Women of childbearing potential who cannot or are unwilling to maintain adequate contraception during the course of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Thomas McCune, MD

    Sentara Norfolk General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2018

First Posted

November 30, 2018

Study Start

January 16, 2020

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

US(1)