Multicenter, Prospective, Rand, PK Study of LCP-Tacro™ Compared to Prograf® Capsules in De Novo Adult Kidney Transplant

Renal Failure Clinical Trial

Official title:

Ph 2 Double-blind, Double-dummy, Multicenter, Prospective, Rand Study of PK of LCP-Tacro™ Tablets Once Daily, Compared to Prograf® Caps, Twice Daily, for Prevention of Acute Allograft Rejection in De Novo Adult Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666951
• Other study ID #: LCP-Tacro 2019
• Status: Completed
• Phase: Phase 2
• First received: August 14, 2012
• Last updated: June 30, 2015
• Start date: November 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2015
• Source: Veloxis Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetics of LCP-Tacro tablets administered once-daily compared to Prograf capsules administered twice-daily after kidney transplantation.

Description:

This is a 2-arm , parallel group, prospective, double-blind, double-dummy, multicenter,clinical trial to evaluate the pharmacokinetics of LCP-Tacro tablets once daily in comparison to Prograf capsules twice-daily after kidney transplantation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria

• Give written consent

• Male and female subjects between the ages of 18 and 70 years, inclusive

• Must be receiving primary or secondary renal allograft from a deceased donor or non- HLA identical living donor

• WOCBP must have a negative pregnancy test

• Must have negative cross-match test and be ABO-compatible

• Must be able to swallow tablets and capsules

Exclusion criteria

• Recipients of any previous nonrenal or concurrent transplant

• Have panel reactive antibody >50%

• Any condition that may affect study drug absorption BMI <18 kg/m2 or > 45 kg/m2

• History of alcohol abuse with less than 6 months of sobriety

• History of recreational drug abuse with less than 6 months of documented abstinence

• Screening 12-lead ECG demonstrating CS abnormalities (including QTc prolongation)

• WOCBP and are either pregnant, lactating, planning to become pregnant or with a positive serum or urine pregnancy test

• Subjects (male or female) with reproductive potential who are unwilling/unable to use a double-barrier method

• Oral temperature (prior to study drug dosing) of 38.0ºC or higher

• CS active infections (eg, those requiring hospitalization, or as judged by the Investigator)

• Known hereditary immunodeficiency

• Malignancies or with a history of malignancies (within the last 5 years) with the exception of local, noninvasive, fully excised cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or cervical carcinoma in situ

• Expect to receive within 2 months after randomization, or have received within 3 months prior to screening, any of the following: sirolimus, everolimus, belatacept, or cyclophosphamide

• Any psychiatric or medical condition that, in the Investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

• Clinically symptomatic CHF or documented EJF of less than 45%

• Significant COPD, pulmonary restrictive disease or significant pulmonary hypertension

• Enrolled in another investigational drug or device study, or who are less than 30 days since discontinuing

• Laboratory variables that are abnormal (outside laboratory reference range) and CS

• Positive results of any of the following serological tests: human immunodeficiency virus (HIV)-1 antibody, hepatitis B virus (HBV) surface antigen (HBsAg), anti-hepatitis B core antibody (HBcAb), and anti-hepatitis C virus (HCV) antibody (HCV Ab)

• Subjects who have had primary focal segmental glomerulosclerosis

• Donor parameters must not include any of the following known conditions:

Donor with positive serological test result for HIV-1, HBV or HCV Donor with history of malignant disease (current or historical) Cold ischemia time >30 hours Non-heart-beating donor

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Failure

Intervention

Drug:
• LCP-Tacro tablets
Tacrolimus
• Prograf
Tacrolimus

Locations

Country	Name	City	State
United States	Clinical Investigative Site 000009	Ann Arbor	Michigan
United States	Clinical Investigative Site 00004	Aurora	Colorado
United States	Clinical Investigative Site 000011	Buffalo	New York
United States	Clinical Investigative Site 00001	Charlottesville	Virginia
United States	Clinical Investigative Site 00008	Cleveland	Ohio
United States	Clinical Investigative Site 000013	Dallas	Texas
United States	Clinical Investigative Site 000005	Lexington	Kentucky
United States	Clinical Investigative Site 000010	Livingston	New Jersey
United States	Clinical Investigative Site 00006	New York	New York
United States	Clinical Investigative Site 00003	Philadelphia	Pennsylvania
United States	Clinical Investigative Site 000015	San Diego	California
United States	Clinical Investigative Site 000012	San Francisco	California
United States	Clinical Investigative Site 000002	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Daytime, Nighttime and Overnight Systolic Blood Pressure (SBP) on Day 14.	At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.	14 days	No
Other	Daytime, Nighttime Overnight Systolic Blood Pressure (SBP) on Day 28.	At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Day 28.	28 days	No
Other	Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 14.	At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 14.	14 days	No
Other	Ratio of Nighttime to Daytime Systolic Blood Pressure (SBP) on Day 28.	At selected sites, a 24-hour measurement of blood pressure will be performed to assess the variability (ei, "nighttime dipping") between the two Groups at Days 28.	28 days	No
Other	Evaluation of the Short-term Efficacy of LCP-Tacro After the Start of Dosing.	The efficacy is measured by the number of treatment failures defined as all-cause mortality, Graft Failure, Biopsy Proven Acute Rejection (BPAR) and Lost to follow up.	30 days	No
Primary	Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (AUC) was evaluated on Day 1 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.	1 days	No
Primary	Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (AUC) was evaluated on Day 14 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.	14 days	No
Primary	Pharmacokinetics (AUC) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (AUC) was evaluated on Day 28 in adult de novo kidney recipients. Samples were collected from 0 to 24 hours post dose.	28 days	No
Primary	Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 1 in adult de novo kidney recipients.	1 days	No
Primary	Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 14 in adult de novo kidney recipients.	14 days	No
Primary	Pharmacokinetics (Cmax and C24) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (Cmax and C24) was evaluated on Day 28 in adult de novo kidney recipients.	28 days	No
Primary	Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (Tmax) was evaluated on Day 1 in adult de novo kidney recipients.	1 days	No
Primary	Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (Tmax) was evaluated on Day 14 in adult de novo kidney recipients.	14 days	No
Primary	Pharmacokinetics (Tmax) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (Tmax) was evaluated on Day 28 in adult de novo kidney recipients.	28 days	No
Primary	Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (Fluctuation) was evaluated on Day 14 in adult de novo kidney recipients.	14 days	No
Primary	Pharmacokinetics (Fluctuation) of LCP-Tacro Compared to Prograf After Kidney Transplantation	The pharmacokinetic parameter (Fluctuation) was evaluated on Day 28 in adult de novo kidney recipients.	28 days	No