Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00817206
First received: December 19, 2008
Last updated: May 23, 2011
Last verified: May 2010
  Purpose

This is 2-armed parallel group, prospective, randomized, open-label, multicenter Phase 3 controlled trial to establish the efficacy and safety of conversion from maintenance immunosuppressive therapy with Prograf® capsules (tacrolimus, Astellas Pharma US, Inc., Deerfield, IL) twice daily to maintenance immunotherapy with LCP Tacro™ tablets (tacrolimus, LifeCycle Pharma A/S, Hoersholm, Denmark) once daily for the prevention of acute allograft rejection in stable adult kidney transplant patients. Patients on a stable dose of Prograf® will be randomly assigned to be converted from Prograf® twice daily to LCP Tacro™ once daily or to remain on maintenance therapy with Prograf® twice daily. Patients entering the study will be treated with assigned study drug and followed for one year for patient survival and the incidence of graft rejection or graft loss.


Condition Intervention Phase
Acute Allograft Rejection
Drug: LCP-Tacro™ Tablets (tacrolimus)
Drug: Prograf® capsules (tacrolimus)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Multicenter, Prospective, Randomized Study of the Efficacy and Safety of Conversion From Prograf® Capsules Twice Daily to LCP Tacro™ Tablets Once Daily for the Prevention of Acute Allograft Rejection in Stable Kidney Transplant Patients

Resource links provided by NLM:


Further study details as provided by Veloxis Pharmaceuticals:

Primary Outcome Measures:
  • Composite primary endpoint for noninferiority will be used for efficacy failure within 12 months of randomization: Death, graft failure, biopsy-proven acute rejection or loss to follow-up. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 326
Study Start Date: December 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
Drug: LCP-Tacro™ Tablets (tacrolimus)
Dosage is determined by monitoring trough levels
Other Name: tacrolimus
Active Comparator: 2
Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
Drug: Prograf® capsules (tacrolimus)
Dosage is determined by monitoring of trough levels
Other Name: tacrolimus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women at least 18 years of age who are recipients of a kidney transplant between 3 months and 5 years before the screening date
  • Patients taking oral Prograf® capsules twice daily, at least 2 mg total dose per day, as part of their maintenance immunosuppression therapy, with tacrolimus trough levels of 5 to 15 ng/mL
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before receiving study drug

Exclusion Criteria:

  • Recipients of any transplanted organ other than kidney
  • Recipients of a bone marrow transplant
  • Patients with an eGFR (MDRD7) < 30 mL/min at Screening
  • Patients with a spot protein:creatinine ratio > 0.5
  • Patients with a WBC count ≤ 2.8 ´ 109/L unless the WBC count has been stable for at least 2 weeks and the absolute neutrophil count is > 1.0 ´ 109 /L
  • Patients unable to swallow study medication
  • Patients incapable of understanding the purposes and risks of the study, who cannot give written informed consent and who are unwilling or unable to comply with the study protocol requirements
  • Pregnant or nursing women
  • Patients with reproductive potential who are unwilling/unable to use a double barrier method of contraception
  • Patients who were treated with any other investigational agent within 3 months before Screening
  • Patients who have taken sirolimus or everolimus within 3 months before Screening
  • Patients on concurrent immunosuppression with MMF (CellCept) or MPS delayed-release tablets (Myfortic) who have not been on stable doses for at least 4 weeks before Screening
  • Patients withdrawn from corticosteroids less than 30 days before Screening
  • Patients with an episode of acute rejection requiring antibody therapy within 3 months before Screening
  • Patients treated for acute rejection within 30 days before Screening
  • Patients who are hepatitis C virus (HCV) negative who have received an HCV positive (HCV RNA by polymerase chain reaction or HCV antibody) donor kidney
  • Patients seropositive for human immunodeficiency virus
  • Patients with a current malignancy or a history of malignancy (within the past 5 years), except basal or nonmetastatic squamous cell carcinoma of the skin that has been treated successfully
  • Patients with uncontrolled concomitant infection, a systemic infection requiring treatment, or any other unstable medical condition that could interfere with the study objectives
  • Patients with severe diarrhea, vomiting, active peptic ulcer, or gastrointestinal disorder that may affect the absorption of tacrolimus
  • Patients with 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817206

Locations
United States, California
California Institute of Renal Research/ Sharp Memorial
San Diego, California, United States, 92123
Sponsors and Collaborators
Veloxis Pharmaceuticals
PPD
Investigators
Principal Investigator: Steven Steinberg, M.D. Claifornia Institute of Renal Research/Sharp Memorial
  More Information

No publications provided

Responsible Party: William Polvino, MD, LifeCycle Pharma Inc.
ClinicalTrials.gov Identifier: NCT00817206     History of Changes
Other Study ID Numbers: LCP-Tacro 3001
Study First Received: December 19, 2008
Last Updated: May 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Veloxis Pharmaceuticals:
kidney transplantation
renal transplantation
maintenance immunosuppression
tacrolimus
Prevention of acute allograft rejection

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014