A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen

• Status: Terminated
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Korea, Inc.
• Treatments: Cyclosporine; Cyclosporins; Immunosuppressive Agents; Tacrolimus

Criteria

Inclusion Criteria:

• Patients received a kidney transplant at least 12 months before enrollment.

• Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL.

• Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine.

• Serum creatinine < 2.3 mg/dl at enrollment

• Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial.

• Patients considered clinically stable

Exclusion Criteria:

• Patients who have previously received an organ transplant other than a kidney.

• Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.

• Patients newly diagnosed malignant tumors after organ transplant, but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.

• Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN).

• Proteinuria > 2 g/24 hrs.

• Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment).

• Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center.

• Patients who have liver cirrhosis.

• Patients who are pregnant or breastfeeding.

• Patients who had been HIV-positive.

• Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants.

• Patients who have an unstable medical condition that may affect the evaluation of the study's objectives.

• Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment.

• Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment.

• Patients who are at the risk of drug abuse or mental disorders or communicate difficulties.