Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to demonstrate the pharmacokinetics (PK, measuring the amount of medication in blood samples) and safety of a new medicine, LCP-Tacro™ tablets, and Prograf® capsules, a drug commonly taken by transplant recipients to prevent the body from rejecting a transplanted kidney. LCP-Tacro is a tablet containing the same active ingredient (tacrolimus) that is in Prograf capsules, but the tablet has been designed to release tacrolimus over an extended period so that it only has to be taken once daily. LCP-Tacro is an investigational drug.

This study will evaluate the levels of tacrolimus in the blood in the first two weeks after a kidney transplant in patients randomly assigned (by chance, like flipping a coin) to take either LCP-Tacro™ tablets (tacrolimus) once daily or Prograf® capsules twice daily. In addition, patients will remain on study drug for 360 days in order to evaluate the relative safety of LCP-Tacro™ tablets compared to Prograf over a longer period of time.


Clinical Trial Description

This study was a randomized, parallel-group, open label, multicenter study in adult de novo kidney transplant patients to demonstrate the pharmacokinetics and safety of LCP-Tacro tablets and Prograf capsules in the first 2 weeks after kidney transplantation. In addition the study compared the efficacy and safety of LCP-Tacro and Prograf over an additional 50 weeks after kidney transplantation. Eligible patients were randomized (1:1 ratio) within 12 hours after transplantation (Day 0) to receive either: 1) LCP-Tacro tablets orally once daily (QD) in the morning, with an interval of 24+/- hours between doses, starting at 0.14 mg/kg (the starting daily dose for African-American patients was 0.17 mg/kg), or 2) Prograf capsules in 2 equally divided doses for African-American patients was (0.2 mg/kg total daily dose) as recommended in the U.S. Prescribing Information (Astellas Pharma US, April 2006). Day 1 was defined as the day on which the first morning dose of study medication was given which was to be within 48 hours of transplantation. Subsequent doses of study medication were adjusted to maintain target whole blood tacrolimus trough level of 7 to 20 ng/mL for the remainder of the pharmacokinetic phase of the study (Day1 through Day 14). Twenty-four-hour pharmacokinetic assessments were performed on Days 1, 7, and 14. Following completion of the third and final pharmacokinetic assessment on the morning of Day 14, patients entered the maintenance phase (Days 15 to 360) of the study and remained on their assigned study medication until Day 360. Visits for safety assessments and tacrolimus trough levels during the maintenance phase were on Days 42, 90, 120, 180, 270, and 360. On Day 360, the patients were placed on a maintenance immunosuppressive regimen determined by their treating physician. ;


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00765661
Study type Interventional
Source Veloxis Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date September 2008
Completion date February 2010

See also
  Status Clinical Trial Phase
Completed NCT02763410 - Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT03292029 - Pilot Medical Evaluation of the T50 Test N/A
Suspended NCT04589065 - SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device) N/A
Completed NCT03806998 - Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure Phase 3
Active, not recruiting NCT03672110 - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Phase 3
Completed NCT02325726 - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery. N/A
Completed NCT02116270 - Accelerated Immunosenescence and Chronic Kidney Disease N/A
Completed NCT01388270 - Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis Phase 4
Completed NCT01859273 - Adherence Enhancement for Renal Transplant Patients N/A
Completed NCT00966615 - The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition Phase 4
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01187953 - Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx Phase 3
Completed NCT01008631 - The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers N/A
Completed NCT00737672 - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis Phase 3
Completed NCT00808691 - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit N/A
Recruiting NCT00470769 - The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR N/A
Terminated NCT00338455 - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC Phase 2
Completed NCT03917186 - Desflurane vs. Sevoflurane in Endovascular Aortic Repair Phase 4