Clinical trial NCT00496483: Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Failure
Keywords: Tacrolimus
Pharmacokinetics
Kidney Transplantation
Lead sponsor: Veloxis Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: CTI Clinical Trial and Consulting Services
First posted: 2007-07-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Evaluation of Steady State Tacrolimus Trough Levels (C24).
timeFrame: 7 days
measure: Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
timeFrame: 7 days
measure: Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).
timeFrame: 21 days
measure: Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
timeFrame: 21 days
Secondary outcomes:
measure: Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.
timeFrame: 21 days
measure: Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.
timeFrame: 21 days
measure: Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.
timeFrame: 21 days
measure: Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.
timeFrame: 7 days
measure: Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.
timeFrame: 7 days
measure: Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.
timeFrame: 7 days
measure: Safety Evaluation
timeFrame: 52 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Houston
country: United States
facility: Methodist Hospital Houston
state: Texas
Study officials:
affiliation: Veloxis Pharmaceuticals
name: Alan Glicklich, MD
role: STUDY_DIRECTOR
References: