Study of ISA247 (Voclosporin) in De Novo Renal Transplantation
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Intervention: Voclosporin; tacrolimus
Intervention description: voclosporin 0.4, 0.6, 0.8 mg/kg po BID; tacrolimus 0.05 mg/kg po BID
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 334.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Randomized Controlled Trials; Immunosuppression; Adult; Kidney Transplantation; Treatment Outcome

Summary:

      This study will see if voclosporin is safe and effective in preventing kidney transplant
      rejection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 18 - 65 years inclusive at the time of screening.

          -  Patients must be receiving a first cadaveric or living donor renal transplant.

          -  Patients must be able to receive oral medication at time of randomization.

          -  Females who are not pregnant or nursing or planning to become pregnant during the
             course of the study, or 3 months after last dose of study medication.

          -  Sexually-active women of child-bearing potential (including those who are < 1 year
             postmenopausal) and sexually-active men who are practicing a highly effective method
             of birth control. A highly effective method of birth control is defined as one that
             results in a low failure rate (i.e., less than 1% per year) when used consistently and
             correctly and will include implants, injectables, combined oral contraceptives,
             double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men
             and women of child-bearing potential should continue to practice contraception as
             outlined above during treatment and for ≥ 3 months after the last dose of voclosporin.

          -  Able to give written informed consent prior to screening procedures.

          -  Able to keep study appointments and cooperate with all study requirements, in the
             opinion of the investigator.

        Exclusion Criteria:

          -  Receiving a HLA (human leukocyte antigen)identical living related transplant.

          -  Cold ischemic time > 24 hours.

          -  Peak PRA (panel reactive antibodies) > 30%

          -  Cadaveric donors who are over age 60, non-heart beating donors, or any cadaveric
             donors positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).

          -  Transplantation of multiple grafts (e.g. kidney and pancreas).

          -  Systemic infections requiring continued therapy at the time of entry into this study.
             (Prophylaxis against cytomegalovirus [CMV] and/or pneumocystis carinii pneumonia (PCP)
             infection will be permitted).

          -  Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B
             (HBV) or hepatitis C (HCV) virus. Known negative serology prior to study entry may be
             used.

          -  A current malignancy or history of malignancy within 5 years or a history of lymphoma
             at any time. Subjects can be enrolled with a history of squamous or basal cell
             carcinoma that has been surgically excised or removed with curettage and
             electrodesiccation.

          -  Requires prohibited medications or treatment during the study.

          -  Alanine transaminase (ALT), aspartate transaminase (AST), or gamma-glutamyl
             transferase (GGT) ≥ 3x upper limit of normal (ULN) at time of transplantation.

          -  White blood cell count ≤ 2.8 x 10^9/L.

          -  Triglycerides ≥ 3x ULN.

          -  Pregnant women or nursing mothers.

          -  Has used any investigational drug or device within 28 days or 5 half lives (whichever
             is longer) prior to enrollment.

          -  Previous exposure to voclosporin.

          -  A history of active alcoholism or drug addiction within 1 year prior to study entry.

          -  Weighs < 45 kg (99 lbs) or > 140 kg (308 lbs).

          -  A history of disease, including mental/emotional disorder that would interfere with
             the subject's participation in the study, or that might cause the administration of
             voclosporin to pose a significant risk to the subject, in the opinion of the
             investigator.

          -  Allergy to iodine.