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Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
This study has been completed.
Sponsors and Collaborators: LifeCycle Pharma A/S
CTI Clinical Trial and Consulting Services
Information provided by: LifeCycle Pharma A/S
ClinicalTrials.gov Identifier: NCT00496483
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Immunosuppressive Therapy
Drug: LCP Tacro-2011
Phase II

MedlinePlus related topics: Kidney Transplantation
Drug Information available for: Tacrolimus Tacrolimus anhydrous
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Pharmacokinetics 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

Further study details as provided by LifeCycle Pharma A/S:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: July 2007
Study Completion Date: January 2008
Intervention Details:
    Drug: LCP Tacro-2011
    Once-daily 1 mg, 2 mg, and 5 mg tablets
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496483

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Texas
Methodist Hospital Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
LifeCycle Pharma A/S
CTI Clinical Trial and Consulting Services
  More Information

Study ID Numbers: LCP-Tacro 2011
Study First Received: July 2, 2007
Last Updated: January 23, 2008
ClinicalTrials.gov Identifier: NCT00496483  
Health Authority: United States: Food and Drug Administration

Keywords provided by LifeCycle Pharma A/S:
Tacrolimus
Pharmacokinetics
Kidney Transplantation

Study placed in the following topic categories:
Tacrolimus

ClinicalTrials.gov processed this record on January 16, 2009