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Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients

Information source: Veloxis Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Failure

Intervention: LCP Tacro (tacrolimus) (Drug); Prograf (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Veloxis Pharmaceuticals

Official(s) and/or principal investigator(s):
Alan Glicklich, MD, Study Director, Affiliation: Veloxis Pharmaceuticals

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.

Clinical Details

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 design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Evaluation of Steady State Tacrolimus Trough Levels (C24).

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

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

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

Secondary outcome:

Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.

Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.

Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.

Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.

Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.

Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.

Safety Evaluation

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

University of Cincinnati, Cincinnati, Ohio 45267, United States

Methodist Hospital Houston, Houston, Texas 77030, United States

Additional Information

Starting date: July 2007
Last updated: June 25, 2015

Page last updated: August 23, 2015

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