Kidney FailurePhase 2NCT00765661

Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients

A Phase 2 study testing Tacrolimus (Tacro™) and Prograf in people with Kidney Failure and Renal Failure, run by Veloxis Pharmaceuticals at 1 site 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Failure, Renal Failure
What is being tested?: Tacrolimus (Tacro™) and Prograf
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Feb 2010
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult men and women at least 18 years of age who are recipients of a kidney transplant from a deceased donor or a live donor and who receive their first oral dose of randomized study drug within 48 hours of the transplant surgery (graft reperfusion)

Who cannot join

Recipient of any transplanted organ other than a kidney
Recipients of a kidney from a non-heart beating donor
Recipients of a kidney from an ABO incompatible donor
Recipients of a kidney with a cold ischemia time of ≥ 36 hours
Recipients of a bone marrow or stem cell transplant
Patients with a white blood cell count ≤ 2.8 x 109/L unless the absolute neutrophil count (ANC) is > 1.0 x 109/L

Show all 20Show fewer

Patients with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) enzyme levels > 3 times the upper limit of normal during the 30 days prior to the transplant procedure
Patients who fail a drugs of abuse screen
Patients unable to swallow study medication
Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent, or who are unwilling to comply with the study protocol
Pregnant or nursing women (women of childbearing potential must have a negative serum pregnancy test within seven days prior to receiving study medication)
Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception throughout the duration of the study
Patients who were treated with any other investigational agent in the 30 days prior to enrollment
Patients who are hepatitis C virus (HCV) negative who have received a HCV positive (HCV RNA by polymerase chain reaction (PCR) or HCV antibody) donor kidney
Patients seropositive for human immunodeficiency virus (HIV)
Patients with 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
Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
Patients with severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
Patients with a known hypersensitivity to tacrolimus
Patients with 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

1 site in 1 country.

United States1 site

University of Cincinnati
Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: A Phase 2, Open-Label, Multi-Center, Randomized Trial To Demonstrate The Pharmacokinetics Of LCP-Tacro™ Tablets Once Daily and Prograf® Capsules Twice Daily In Adult De Novo Kidney Transplant Patients

The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a transplanted kidney. LCP-Tacro is a tablet containing the same active ingredient (tacrolimus) that is in Prograf capsules, but the tablet has been designed to release tacrolimus over an extended period so that it only has to be taken once daily. LCP-Tacro is an investigational drug.

This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a kidney transplant in patients randomly assigned (by chance, like flipping a coin) to take either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In addition, patients will remain on study drug for 360 days in order to evaluate the relative safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.

Read the detailed description

This study was a randomized, parallel-group, open label, multicenter study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of LCP-Tacro tablets and Prograf capsules in the first 2 weeks after kidney transplantation. In addition the study compared the efficacy and safety of LCP-Tacro and Prograf over an additional 50 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive either: 1) LCP-Tacro tablets orally once daily (QD) in the morning, with an interval of 24+/- hours between doses, starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg), or 2) Prograf capsules in 2 equally divided doses for African-American patients was (0.2 mg/kg total daily dose) as recommended in the U.S. Prescribing Information (Astellas Pharma US, April 2006). Day 1 was defined as the day on which the first morning dose of study medication was given which was to be within 48 hours of transplantation. Subsequent doses of study medication were adjusted to maintain target whole blood tacrolimus trough level of 7 to 20 ng/mL for the remainder of the pharmacokinetic phase of the study (Day1 through Day 14). Twenty-four-hour pharmacokinetic assessments were performed on Days 1, 7, and 14. Following completion of the third and final pharmacokinetic assessment on the morning of Day 14, patients entered the maintenance phase (Days 15 to 360) of the study and remained on their assigned study medication until Day 360. Visits for safety assessments and tacrolimus trough levels during the maintenance phase were on Days 42, 90, 120, 180, 270, and 360. On Day 360, the patients were placed on a maintenance immunosuppressive regimen determined by their treating physician.

Conditions: Kidney Failure, Renal Failure
Being tested: Tacrolimus (Tacro™), Prograf
Keywords: Kidney, Transplantation, Immunosuppression, Tacrolimus, Prograf
Medical subject headings: Renal Insufficiency

What participants receive

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

Tacrolimus (Tacro™)Drug
Also called LCP -Tacro
The initial dose at 0.14 mg/kg (daily dose for African-American is 0.17 mg/kg), oral in the morning (before noon) within 12 hours after transplantation. Subsequent doses adjusted to maintain a target tacrolimus trough level of 7 - 20 ng/mL for (PK) phase of the study (through Study Day 14). Post PK maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care.
Other Names:
Tacrolimus modified-release
PrografDrug
Also called tacrolimus
Prograf® capsules, twice daily: Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for the remainder of the pharmacokinetic (PK) phase of the study (through Study Day 14). Post PK patient enter the maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care.
Other name: tacrolimus

Study groups in NCT00765661
Study group	Role	What they receive
LCP-Tacro	Experimental	The initial dose starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg), will be administered orally in the morning (before noon) within 12 hours after transplantation. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for the remainder of the pharmacokinetic (PK) phase of the study (through Study Day 14). Post PK patient enter the maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care. Receives: Drug: Tacrolimus (Tacro™)
Prograf (tacrolimus)	Active comparator	Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for the remainder of the pharmacokinetic (PK) phase of the study (through Study Day 14). Post PK patient enter the maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care. Other name: tacrolimus Receives: Drug: Prograf

What is being measured

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

Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients.
Comparison of the proportion of patients achieving sufficient tacrolimus whole blood trough levels (7 to 20 ng/mL) during the first 14 days post-transplantation
Measured: 14 days

Secondary outcomes (2)

Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.
To compare the pharmacokinetics (AUC, Cmax, C24/Cmin) on Days 1, 7 and 14 of LCP-Tacro with the pharmacokinetics of Prograf in adult de novo kidney transplant patients.
Measured: 14 days
Evaluation of Safety and Efficacy of LCP-Tacro Compared to Prograf in Adult de Novo Kidney Transplant Patients.
To evaluate the efficacy and safety of LCP-Tacro compared to Prograf in the first 12 months after kidney transplantation.
Efficacy was assessed by monitoring biopsy-proven acute rejection (BPAR) according to the Banff criteria, graft failure (defined by a patient starting dialysis for at least 30 days, nephrectomy, retransplantation, or death with a functioning graft), patient survival, and renal function based on serum creatinine and glomerular filtration rate (GFR), based on serum creatinine, serum urea nitrogen, and serum albumin.
Measured: 12 months

Timeline

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

Sep 2008Feb 2010

First posted3 Oct 2008 (estimated)
Study startSep 2008
Primary completionFeb 2010
Study completionFeb 2010

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 Kidney 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00765661
Sponsor's protocol ID: LCP - Tacro 2017
Status last verified: May 2015
First submitted: 2 Oct 2008
Last updated: 19 May 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 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-Label, Multi-Center, Randomized Trial To Demonstrate The Pharmacokinetics Of LCP-Tacro™ Tablets Once Daily and Prograf® Capsules Twice Daily In Adult De Novo Kidney Transplant Patients
ClinicalTrials.gov ID: NCT00765661
Acronym / sponsor ID: LCP - Tacro 2017
Conditions: Kidney Failure, Renal Failure
Keywords: Kidney, Transplantation, Immunosuppression, Tacrolimus, Prograf
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Veloxis PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: CTI Clinical Trial and Consulting Services, Aptuit
Study start: Sep 2008
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 3 Oct 2008 (estimated)
Results: Posted 19 May 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LCP-Tacro	Experimental	Drug: Tacrolimus (Tacro™)The initial dose starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg), will be administered orally in the morning (before noon) within 12 hours after transplantation. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for the remainder of the pharmacokinetic (PK) phase of the study (through Study Day 14). Post PK patient enter the maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care.
Prograf (tacrolimus)	Active comparator	Drug: PrografStarting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for the remainder of the pharmacokinetic (PK) phase of the study (through Study Day 14). Post PK patient enter the maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care. Other name: tacrolimus

Who may qualify

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

Key inclusion criteria (1 listed)

Adult men and women at least 18 years of age who are recipients of a kidney transplant from a deceased donor or a live donor and who receive their first oral dose of randomized study drug within 48 hours of the transplant surgery (graft reperfusion)

Key exclusion criteria (20 listed)

Recipient of any transplanted organ other than a kidney
Recipients of a kidney from a non-heart beating donor
Recipients of a kidney from an ABO incompatible donor
Recipients of a kidney with a cold ischemia time of ≥ 36 hours
Recipients of a bone marrow or stem cell transplant

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
Tacrolimus (Tacro™)Also: LCP -TacroThe initial dose at 0.14 mg/kg (daily dose for African-American is 0.17 mg/kg), oral in the morning (before noon) within 12 hours after transplantation. Subsequent doses adjusted to maintain a target tacrolimus trough level of 7 - 20 ng/mL for (PK) phase of the study (through Study Day 14). Post PK maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care. Other Names: Tacrolimus modified-release	Drug	LCP-Tacro
PrografAlso: tacrolimusPrograf® capsules, twice daily: Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Subsequent doses adjusted to maintain a target whole blood tacrolimus trough level of 7 - 20 ng/mL for the remainder of the pharmacokinetic (PK) phase of the study (through Study Day 14). Post PK patient enter the maintenance phase of the study and remain on assigned study drug until Study Day 360. Dose of study drug was adjusted to maintain tacrolimus trough levels between 5 - 20 ng/mL from Day 15 until Day 90 and then between 5 - 15 ng/mL for the remainder of the study according to local standard of care. Other name: tacrolimus	Drug	Prograf (tacrolimus)

Primary outcome

Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients.
Time frame: 14 days
Comparison of the proportion of patients achieving sufficient tacrolimus whole blood trough levels (7 to 20 ng/mL) during the first 14 days post-transplantation

2 secondary outcomes

Comparative Pharmacokinetics Between LCP-Tacro and Prograf Within 14 Days After Kidney Transplantation.
Time frame: 14 days
Evaluation of Safety and Efficacy of LCP-Tacro Compared to Prograf in Adult de Novo Kidney Transplant Patients.
Time frame: 12 months

Results and safety

Results posted to the registry on 19 May 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
Group A	32	32
Group B	31	31

Primary outcome: Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients.

Time frame: 14 days. Number. Unit: percentage of patients

Measure	Group A n = 28	Group B n = 28
Value	78.57	57.14

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from Day 1 and up to end of study for a total of 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	15 of 32 (46.9%)	32 of 32 (100%)	Not reported
Group B	17 of 31 (54.8%)	30 of 31 (96.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 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.

Rita Alloway, PharmD principal investigator

University of Cincinnati, allowarr@ucmail.uc.edu

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tacrolimus (Tacro™) and Prograf in people with Kidney Failure and Renal Failure, run by Veloxis Pharmaceuticals at 1 site 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 1 inclusion and 20 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 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 19 May 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?

Pharmacokinetics of LCP-Tacro™ Tablets in the First 14 Days After Transplantation in Adult de Novo Kidney Recipients. (time frame: 14 days). 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 NCT00765661.

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 19 May 2015.