A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment

• Status: Withdrawn
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS and Prograf® in post renal transplanted patients.

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

Details

• Lead Sponsor: EMS
• Treatments: Immunosuppressive Agents; Methylprednisolone; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

• Age > 18 year old

• Patient is receiving kidney from live or death donor

• Kidney donor younger than 65 years old

• PRA ≤ 30%

• Negative pregnancy test for women

• Patient agreement to practice birth control

• Patient has been fully informed and has given written informed consent

Exclusion Criteria:

• HLA identical

• Patient multi-organ transplant recipient

• Any pathology or past medical condition that can interfere with this protocol

• Allergy or intolerance of any study medication