NCT01962922

Brief Summary

Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

3 active sites

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

October 8, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 14, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 15, 2016

Completed
Last Updated

June 6, 2018

Status Verified

May 1, 2018

Enrollment Period

1.7 years

First QC Date

October 8, 2013

Results QC Date

February 23, 2016

Last Update Submit

May 2, 2018

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (9)

  • Evaluation of AUC(0-24) for Envarsus XR and IR-Tac

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.

    Day 7

  • Evaluation of C(Max) for Envarsus XR and IR-Tac

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.

    Day 7

  • Evaluation of C(Min) for Envarsus XR and IR-Tac

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.

    Day 7

  • Evaluation of AUC(0-24) for Envarsus XR and IR-Tac

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.

    Day 14

  • Evaluation of C(Max) for Envarsus XR and IR-Tac

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.

    Day 14

  • Evaluation of C(Min) for Envarsus XR and IR-Tac

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours

    Day 14

  • Evaluation of AUC(0-24) for Envarsus XR and IR-Tac

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.

    Day 21

  • Evaluation of C(Max) for Envarsus XR and IR-Tac

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate C(max). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.

    Day 21

  • Evaluation of C(Min) for Envarsus XR and IR-Tac

    Tacrolimus whole blood concentrations obtained from the central lab was used for PK analysis. Actual sampling time was used to calculate AUC(0-24). Arithmetic mean and standard deviation is given below. Nominal time points used were: Pre-dose (C0) and then 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 13, 14, 16, 18 and 24 hours.

    Day 21

Study Arms (2)

LCP-Tacro

ACTIVE COMPARATOR

Envarsus XR

Drug: LCP-Tacro

Tacrolimus - IR

ACTIVE COMPARATOR

Tacrolimus

Drug: Tacrolimus -IR

Interventions

LCP-TacroDRUG

once-daily extended release tablet

Also known as: Envarsus XR
LCP-Tacro
Tacrolimus -IRDRUG

twice daily capsules

Also known as: Prograf, Generic Tacrolimus
Tacrolimus - IR

Eligibility Criteria

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

You may qualify if:

  • Age ≥18-80 old, male or female
  • African Americans
  • Willing to give written informed consent and to comply with study visits and restrictions, including being able to speak, write and understand English
  • Pt who have received a primary or secondary transplant
  • Pt least 6 (six) mth post-transplant and on a stable dose of tacrolimus
  • BMI ≥19
  • Pt who are sero-positive for Hepatitis B or C positive may also be enrolled
  • Pt maintained on concurrent immunosuppression with stable doses during screening
  • Pt on a proton PPI remain on the same PPI formulation and dose during the PK portion of the study.
  • During PK phase Only: Pt taking any medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food supplements (including grapefruit, and pomegranate products), or medications must continue the same dose and are willing to continue the same dose/routine
  • During PK phase Only: the patient is not scheduled to begin any new medication that could interfere with tacrolimus blood levels, including prescription and over-the-counter medications, herbal or food

You may not qualify if:

  • Evidence of acute rejection episode within the past three months
  • Pt not Africa-American
  • Recipients of organ transplants other than kidney
  • Known to be HIV positive at transplant
  • Pt with recurrent focal segmental glomerulosclerosis (FSGS)
  • Pt with any severe medical condition (including infection) requiring acute or chronic treatment
  • Pt with a positive DSA
  • Pt with a positive BK virus results
  • GFR \< 25 ml/min measured by MDRD4 as SOC within last 30 days
  • Patients with AST, ALT, total bilirubin \> 2.5 x ULN or evidence of severe liver disease
  • Pt with WBC \< to 2000/mm3 or ANC \< to 1500 mm3 with PLT \< 75,000/mm3 or HGB \< 8 g/dl
  • Pt with mental or physical conditions or known non-adherence
  • Presence of intractable immunosuppressant complications of side effects resulting in dose adjustment of tacrolimus
  • Exposed to investigational therapy within 30 days prior to enrollment
  • No anticipated changes in the immunosuppressive regimen, other than those specified by the study protocol
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Illinois, Chicago

Chicago, Illinois, 60612, United States

Location

Washingto University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Trofe-Clark J, Brennan DC, West-Thielke P, Milone MC, Lim MA, Neubauer R, Nigro V, Bloom RD. Results of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-Release Versus Extended-Release Tacrolimus in African American Kidney Transplant Recipients. Am J Kidney Dis. 2018 Mar;71(3):315-326. doi: 10.1053/j.ajkd.2017.07.018. Epub 2017 Nov 20.

    PMID: 29162334DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Leslie Callahan
Organization
Veloxis Pharmaceutical
lca@veloxis.com
732-321-3221

Study Officials

  • Leslie Callahan, RN

    Veloxis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 14, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

June 6, 2018

Results First Posted

August 15, 2016

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)