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

NCT00817206 | Completed Phase 3 Results DMC

• 1 other identifier: LCP-Tacro 3001
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Failure

Keywords

kidney transplantation; renal transplantation; maintenance immunosuppression; tacrolimus; Prevention of acute allograft rejection

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up.

  12 months

Study Arms (2)

LCP-Tacro

EXPERIMENTAL

LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)

Drug: LCP-Tacro

Prograf (tacrolimus)

ACTIVE COMPARATOR

Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)

Drug: Prograf

Interventions

LCP-Tacro DRUG

LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.

Also known as: tacrolimus, tacrolimus modified release

LCP-Tacro

Prograf DRUG

Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.

Also known as: tacrolimus

Prograf (tacrolimus)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Veloxis Pharmaceuticals: lead
• PPD Development, LP: collaborator

Study Sites (1)

California Institute of Renal Research/ Sharp Memorial

San Diego, California, 92123, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Christina Sylvest
• Organization: Veloxis Pharmaceuticals A/S

csy@veloxis.com

+45 20553877

Study Officials

• Steven Steinberg, M.D.

  Claifornia Institute of Renal Research/Sharp Memorial

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2008
• First Posted: January 6, 2009
• Study Start: December 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: September 10, 2015
• Results First Posted: September 10, 2015

Record last verified: 2015-08

Locations

US (1)