Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
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
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2007
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 2, 2007
CompletedFirst Posted
Study publicly available on registry
July 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
July 23, 2015
CompletedJuly 23, 2015
June 1, 2015
8 months
July 2, 2007
May 29, 2014
June 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Evaluation of Steady State Tacrolimus Trough Levels (C24).
Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.
7 days
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.
7 days
Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.
21 days
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).
21 days
Secondary Outcomes (7)
Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.
21 days
Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.
21 days
Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.
21 days
Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.
7 days
Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.
7 days
- +2 more secondary outcomes
Study Arms (1)
LCP-Tacro (tacrolimus)
ACTIVE COMPARATORExperimental: LCP Tacro; investigational product LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
Interventions
Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses. Other Names: Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses. Other Names: Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Methodist Hospital Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christina Sylvest, Sr VP, Global Clinical Development and Operations
- Organization
- Veloxis A/S
Study Officials
- STUDY DIRECTOR
Alan Glicklich, MD
Veloxis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2007
First Posted
July 4, 2007
Study Start
July 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
July 23, 2015
Results First Posted
July 23, 2015
Record last verified: 2015-06