Renal FailurePhase 2NCT00496483

Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients

A Phase 2 study testing LCP Tacro (tacrolimus) and Prograf in people with Renal Failure, run by Veloxis Pharmaceuticals at 2 sites in United States.

Completed

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

Official record

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Trial summary

A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Renal Failure
What is being tested?: LCP Tacro (tacrolimus) and Prograf
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: Jul 2007to Mar 2008
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women 18-65 years of age who are recipients of a renal transplant at least 6 months prior to enrollment
Patients on oral Prograf therapy as part of their maintenance immunosuppression therapy, with stable doses and trough levels of tacrolimus of 7-12 ng/mL for at least two weeks prior to enrollment.
Patients maintained on concurrent immunosuppression with mycophenolate mofetil (MMF, CellCept) or mycophenolic acid delayed-release tablets (Myfortic), with stable doses for at least two weeks prior to enrollment
Patients with serum creatinine < 2.0mg/dL prior to enrollment
Able to swallow study medication
Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study
Women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication
Patients who successfully pass a drug screen

Who cannot join

Recipients of any transplanted organ other than a kidney
White blood cell count < 2.8 x 10^9 /L
Patients who are receiving a total dose of Prograf for 24 hours < 3mg
Patients unable or unwilling to provide informed consent
Pregnant or nursing women
Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception

Show all 18Show fewer

Administration of other investigational agent in the three months prior to enrollment
Patient receiving any drug interfering with tacrolimus metabolism
Patients who have taken sirolimus within the past three months prior to screening
Patient with an episode of acute cellular requiring antibody therapy within the 6 months prior to enrollment
Patient treated for acute cellular rejection within the 30 days prior to enrollment
Patient who is HCV negative and has received an HCV positive (HCV RNA by PCR or HCV antibody) donor kidney
Patient has a current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully
Patient has uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
Patient has severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
Patient will require therapy with any immunosuppressive agent other than those prescribed in the study
Patient has a known hypersensitivity to corticosteroids, mycophenolate mofetil, mycophenolic acid or tacrolimus
Patient has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Cincinnati
Cincinnati, Ohio, 45267
Methodist Hospital Houston
Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II, Open-Label, Multi-Center Prospective, Conversion Study in Stable Kidney Transplant Patients to Compare the Pharmacokinetics of LCP-Tacro Tablets Once-A-Day to Prograf® Capsules Twice-A-Day

Read the detailed description

Stable kidney transplant patients who fulfill all I/E criteria will be enrolled and kept on Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for Prograf, all patients will be converted to once daily LCP-Tacro for 7 days with no dose changes allowed. On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day 22 patients will be converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days ending with a safety assessment on day 53.

Conditions: Renal Failure
Being tested: LCP Tacro (tacrolimus), Prograf
Keywords: Tacrolimus, Pharmacokinetics, Kidney Transplantation
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 Tacro (tacrolimus)Drug
Also called tacrolimus
Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
Other Names:
Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
PrografDrug
Also called Tacrolimus
Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
Other Names:
Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.

Study groups in NCT00496483
Study group	Role	What they receive
LCP-Tacro (tacrolimus)	Active comparator	Experimental: LCP Tacro; investigational product LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets. Receives: Drug: LCP Tacro (tacrolimus); Drug: Prograf

What is being measured

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

Evaluation of Steady State Tacrolimus Trough Levels (C24).
Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.
Measured: 7 days
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.
Measured: 7 days
Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.
Measured: 21 days
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).
Measured: 21 days

Secondary outcomes (7)

Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.
Cmax and Cavg was measured at day 21 (Cmin was measured as part of the primary outcome).
Measured: 21 days
Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.
Tmax was measured at day 21 (Cmin was measured as part of the primary outcome).
Measured: 21 days
Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.
Degree og fluctuation and degree of swing was measured at day 21 (Cmin was measured as part of the primary outcome).
Measured: 21 days
Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.
Cmax and Cavg was measured at baseline day 7 (Cmin was measured as part of the primary outcome).
Measured: 7 days
Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.
Tmax was measured at baseline day 7 (Cmin was measured as part of the primary outcome).
Measured: 7 days
Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.
Degree og fluctuation and degree of swing was measured as baseline at day 7 (Cmin was measured as part of the primary outcome).
Measured: 7 days
Safety Evaluation
A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.
Measured: 52 days

Timeline

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

Jul 2007Mar 2008

First posted4 Jul 2007 (estimated)
Study startJul 2007
Primary completionMar 2008
Study completionMar 2008

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.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00496483
Sponsor's protocol ID: LCP-Tacro 2011
Status last verified: Jun 2015
First submitted: 2 Jul 2007
Last updated: 23 Jul 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Open-Label, Multi-Center Prospective, Conversion Study in Stable Kidney Transplant Patients to Compare the Pharmacokinetics of LCP-Tacro Tablets Once-A-Day to Prograf® Capsules Twice-A-Day
ClinicalTrials.gov ID: NCT00496483
Acronym / sponsor ID: LCP-Tacro 2011
Conditions: Renal Failure
Keywords: Tacrolimus, Pharmacokinetics, Kidney Transplantation
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Veloxis PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: CTI Clinical Trial and Consulting Services
Study start: Jul 2007
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 4 Jul 2007 (estimated)
Results: Posted 23 Jul 2015

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LCP-Tacro (tacrolimus)	Active comparator	Drug: LCP Tacro (tacrolimus), Drug: PrografExperimental: LCP Tacro; investigational product LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Men and women 18-65 years of age who are recipients of a renal transplant at least 6 months prior to enrollment
Patients on oral Prograf therapy as part of their maintenance immunosuppression therapy, with stable doses and trough levels of tacrolimus of 7-12 ng/mL for at least two weeks prior to enrollment.
Patients maintained on concurrent immunosuppression with mycophenolate mofetil (MMF, CellCept) or mycophenolic acid delayed-release tablets (Myfortic), with stable doses for at least two weeks prior to enrollment
Patients with serum creatinine < 2.0mg/dL prior to enrollment
Able to swallow study medication

Key exclusion criteria (18 listed)

Recipients of any transplanted organ other than a kidney
White blood cell count < 2.8 x 10^9 /L
Patients who are receiving a total dose of Prograf for 24 hours < 3mg
Patients unable or unwilling to provide informed consent
Pregnant or nursing women

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 Tacro (tacrolimus)Also: tacrolimusPrograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses. Other Names: Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.	Drug	LCP-Tacro (tacrolimus)
PrografAlso: TacrolimusPrograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses. Other Names: Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.	Drug	LCP-Tacro (tacrolimus)

Primary outcome

Evaluation of Steady State Tacrolimus Trough Levels (C24).
Time frame: 7 days
Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
Time frame: 7 days
Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.
Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).
Time frame: 21 days
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
Time frame: 21 days
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).

7 secondary outcomes

Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.
Time frame: 21 days
Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.
Time frame: 21 days
Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.
Time frame: 21 days
Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.
Time frame: 7 days
Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.
Time frame: 7 days
Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.
Time frame: 7 days
Safety Evaluation
Time frame: 52 days

Results and safety

Results posted to the registry on 23 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LCP-Tacro	60	48

Primary outcome: Evaluation of Steady State Tacrolimus Trough Levels (C24).

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

Measure	Prograf n = 47
Value	7.00 (1.54)

Population analysed: 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. The arithmetic mean and standard deviation is given.

Primary outcome: Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).

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

Measure	Prograf n = 47
Value	218.82 (55.99)

Population analysed: 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. The arithmetic mean and standard deviation is given.

Primary outcome: Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).

Time frame: 21 days. Mean (Standard Deviation). Unit: ng/mL

Measure	LCP-Tacro n = 46
Value	6.94 (2.20)

Population analysed: 48 completed treatment with LCP-Tacro but one patient was excluded from the PP analysis due to inappropriate conversion rate. Another patient discontinued before the Day 21 visit. The arithmetic mean and standard deviation is given.

Primary outcome: Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).

Time frame: 21 days. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	LCP-Tacro n = 46
Value	218.03 (68.23)

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LCP-Tacro	2 of 51 (3.9%)	35 of 51 (68.6%)	Not reported
Prograf	0 of 59 (0%)	19 of 59 (32.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Alan Glicklich, MD study director

Veloxis Pharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LCP Tacro (tacrolimus) and Prograf in people with Renal Failure, run by Veloxis Pharmaceuticals at 2 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 8 inclusion and 18 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 23 Jul 2015). 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 Steady State Tacrolimus Trough Levels (C24). (time frame: 7 days). The study lists 4 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 NCT00496483.

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 23 Jul 2015.