Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Cyclosporine; Cyclosporins; Tacrolimus

Criteria

Inclusion Criteria:

• Serum creatinine < 200 µmol/l (< 2.3 mg/dl) at enrollment.

• Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study.

• Capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent (signed Informed Consent has been obtained).

Exclusion Criteria:

• Previously received an organ transplant other than a kidney.

• Acute rejection episode within 12 weeks prior to enrollment, or an acute rejection episode within the 24 weeks prior to enrollment that required anti-lymphocyte antibody therapy