Trial record 1 of 1 for:    NCT00817206
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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

December 19, 2008
May 23, 2011
December 2008
February 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00817206 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Allograft Rejection
  • Drug: LCP-Tacro™ Tablets (tacrolimus)
    Dosage is determined by monitoring trough levels
    Other Name: tacrolimus
  • Drug: Prograf® capsules (tacrolimus)
    Dosage is determined by monitoring of trough levels
    Other Name: tacrolimus
  • Experimental: 1
    LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)
    Intervention: Drug: LCP-Tacro™ Tablets (tacrolimus)
  • Active Comparator: 2
    Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)
    Intervention: Drug: Prograf® capsules (tacrolimus)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817206
LCP-Tacro 3001
Yes
William Polvino, MD, LifeCycle Pharma Inc.
Veloxis Pharmaceuticals
PPD
Principal Investigator: Steven Steinberg, M.D. Claifornia Institute of Renal Research/Sharp Memorial
Veloxis Pharmaceuticals
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP