Renal FailurePhase 3NCT01962922

Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.

A Phase 3 study testing LCP-Tacro and Tacrolimus -IR in people with Renal Failure, run by Veloxis Pharmaceuticals at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Renal Failure
What is being tested?: LCP-Tacro and Tacrolimus -IR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 3 sitesUnited States
Study dates: Nov 2013to Aug 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

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

Show all 19Show fewer

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
Pt with severe diabetic gastroparesis or other severe GI disturbances
Pt who have underwent gastric banding or gastric bypass at any time pre or post-transplant
Pregnant or nursing (lactating) women, or planning to become pregnant
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant who are unwilling to use a defined SOC of method

Trial locations and contacts

3 sites in 1 country.

United States3 sites

University of Illinois, Chicago
Chicago, Illinois, 60612
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washingto University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.

Read the detailed description

This is open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of once daily dosing of LCP-Tacro tablets to tacrolimus capsules administered twice daily in stable African American kidney transplant patients.

Approximately 72 male and female African American renal transplant patients on table immunosuppression regimens will be randomly assigned in a 1:1 ratio to one of two sequences:

Sequence 1: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will continue on generic tacrolimus capsules on days 1-7 (24 hours PK profile on day 7) then patients are switched to LCP-Tacro tablets (at 15% lower dose of twice daily generic tacrolimus) on day 8.

Sequence 2: (n=36) 18 patients requiring less than 0.15 mg/kg/day and 18 patients requiring equal to or greater than 0.15 mg/kg/day. Patients will receive LCP-Tacro tablets (at 15% lower dose than generic tacrolimus twice daily formulation) on days 1-7 (24 hour PK profile on day 7) patients are switched back to twice daily generic tacrolimus treatment beginning on day 8.

Conditions: Renal Failure
Being tested: LCP-Tacro, Tacrolimus -IR
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LCP-TacroDrug
Also called Envarsus XR
once-daily extended release tablet
Tacrolimus -IRDrug
Also called Prograf, Generic Tacrolimus
twice daily capsules

Study groups in NCT01962922
Study group	Role	What they receive
LCP-Tacro	Active comparator	Envarsus XR Receives: Drug: LCP-Tacro
Tacrolimus - IR	Active comparator	Tacrolimus Receives: Drug: Tacrolimus -IR

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2013Aug 2015

First posted14 Oct 2013 (estimated)
Study startNov 2013
Primary completionJul 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Renal FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01962922
Sponsor's protocol ID: LCP-Tacro 3004
Status last verified: May 2018
First submitted: 8 Oct 2013
Last updated: 6 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 29162334

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.
ClinicalTrials.gov ID: NCT01962922
Acronym / sponsor ID: LCP-Tacro 3004
Conditions: Renal Failure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Veloxis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Jul 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 14 Oct 2013 (estimated)
Results: Posted 15 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 72 male and female African American renal transplant patients on table immunosuppression regimens will be randomly assigned in a 1:1 ratio to one of two sequences:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LCP-Tacro	Active comparator	Drug: LCP-TacroEnvarsus XR
Tacrolimus - IR	Active comparator	Drug: Tacrolimus -IRTacrolimus

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (19 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LCP-TacroAlso: Envarsus XRonce-daily extended release tablet	Drug	LCP-Tacro
Tacrolimus -IRAlso: Prograf, Generic Tacrolimustwice daily capsules	Drug	Tacrolimus - IR

Primary outcome

Evaluation of AUC(0-24) for Envarsus XR and IR-Tac
Time frame: Day 7
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.
Evaluation of C(Max) for Envarsus XR and IR-Tac
Time frame: Day 7
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.
Evaluation of C(Min) for Envarsus XR and IR-Tac
Time frame: Day 7
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.
Evaluation of AUC(0-24) for Envarsus XR and IR-Tac
Time frame: Day 14
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.
Evaluation of C(Max) for Envarsus XR and IR-Tac
Time frame: Day 14
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.
Evaluation of C(Min) for Envarsus XR and IR-Tac
Time frame: Day 14
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
Evaluation of AUC(0-24) for Envarsus XR and IR-Tac
Time frame: Day 21
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.
Evaluation of C(Max) for Envarsus XR and IR-Tac
Time frame: Day 21
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.
Evaluation of C(Min) for Envarsus XR and IR-Tac
Time frame: Day 21
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.

Results and safety

Results posted to the registry on 15 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	27	23
Sequence 2	23	23

Primary outcome: Evaluation of AUC(0-24) for Envarsus XR and IR-Tac

Time frame: Day 7. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Envarsus XR n = 23	Tacrolimus - IR n = 23
Value	251.9 (77.78)	247.9 (102.33)

Population analysed: For this outcome measure the PK population N=46 was used.

Primary outcome: Evaluation of C(Max) for Envarsus XR and IR-Tac

Time frame: Day 7. Mean (Standard Deviation). Unit: ng/mL

Measure	Envarsus XR n = 23	Tacrolimus - IR n = 23
Value	16.53 (5.464)	26.84 (13.296)

Population analysed: For this outcome measuure the Protocol PK population of N = 46 was used.

Primary outcome: Evaluation of C(Min) for Envarsus XR and IR-Tac

Time frame: Day 7. Mean (Standard Deviation). Unit: ng/mL

Measure	Envarsus XR n = 23	Tacrolimus - IR n = 23
Value	7.51 (2.487)	7.06 (2.843)

Population analysed: For this outcome measure the Protocol PK population N= 46 was used.

Primary outcome: Evaluation of AUC(0-24) for Envarsus XR and IR-Tac

Time frame: Day 14. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Envarsus XR n = 23	Tacrolimus - IR n = 23
Value	293.3 (124.40)	225.7 (56.27)

Population analysed: For this outcome measure the PK population N=46 was used

Adverse events

Time frame: Adverse events were collected from start of first dose of study medication, through and including last dose of study medication during the up to 6 month extension period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Envarsus XR	3 of 50 (6%)	23 of 50 (46%)	Not reported
Tacrolimus - IR	4 of 50 (8%)	22 of 50 (44%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29162334Trofe-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie Callahan, RN study director

Veloxis Pharmaceuticals

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LCP-Tacro and Tacrolimus -IR in people with Renal Failure, run by Veloxis Pharmaceuticals at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of AUC(0-24) for Envarsus XR and IR-Tac (time frame: Day 7). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01962922, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.