Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients

This study has been completed.

Sponsor:

Collaborator:

CTI Clinical Trial and Consulting Services

Information provided by (Responsible Party):

Veloxis Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00496483

First received: July 2, 2007

Last updated: July 3, 2012

Last verified: July 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 2, 2007
Last Updated Date	July 3, 2012
Start Date ^ICMJE	July 2007
Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 3, 2012)	Evaluation of steady state tacrolimus exposure (AUC 0-24) and trough levels (C24) in stable kidney transplant recipients converted from Prograf® (tacrolimus, Astellas Pharma US, Inc.) to LCP-Tacro in a three sequence study design. [ Time Frame: 22 days ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: July 2, 2007)	Evaluation of steady state tacrolimus exposure (AUC 0-24) and trough levels (C24) in stable kidney transplant recipients converted from Prograf® (tacrolimus, Astellas Pharma US, Inc.) to LCP-Tacro in a three sequence study design. [ Time Frame: 22 days ]
Change History	Complete list of historical versions of study NCT00496483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 3, 2012)	To determine whether patients can be safely converted from Prograf to LCP-Tacro [ Time Frame: 52 days ] [ Designated as safety issue: Yes ] To evaluate tacrolimus exposure and trough concentrations in stable kidney transplant recipients converted from Prograf to LCP-Tacro in a three-sequence study design [ Time Frame: 22 days ] [ Designated as safety issue: Yes ] To determine the mean conversion ratio between Prograf twice-a-day and LCP Tacro once-a-day [ Time Frame: 22 days ] [ Designated as safety issue: No ] To evaluate the safety of LCP-Tacro compared to Prograf [ Time Frame: 52 days ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: July 2, 2007)	To determine whether patients can be safely converted from Prograf to LCP-Tacro [ Time Frame: 52 days ] To evaluate tacrolimus exposure and trough concentrations in stable kidney transplant recipients converted from Prograf to LCP-Tacro in a three-sequence study design [ Time Frame: 22 days ] To determine the mean conversion ratio between Prograf twice-a-day and LCP Tacro once-a-day [ Time Frame: 22 days ] To evaluate the safety of LCP-Tacro compared to Prograf [ Time Frame: 52 days ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
Official Title ^ICMJE	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
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Kidney Transplantation Immunosuppressive Therapy
Intervention ^ICMJE	Drug: LCP Tacro-2011 Once-daily 1 mg, 2 mg, and 5 mg tablets
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	March 2008
Primary Completion Date	March 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00496483
Other Study ID Numbers ^ICMJE	LCP-Tacro 2011
Has Data Monitoring Committee	No
Responsible Party	Veloxis Pharmaceuticals
Study Sponsor ^ICMJE	Veloxis Pharmaceuticals
Collaborators ^ICMJE	CTI Clinical Trial and Consulting Services
Investigators ^ICMJE	Not Provided
Information Provided By	Veloxis Pharmaceuticals
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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