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

EMS

Status and phase: Withdrawn; Phase 3

Conditions: Renal Transplant

Treatments: Drug: Prograf; Drug: Tacrolimus from EMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01244659

TACEMS0410

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Tacrolimus from EMS

Experimental group

Description:

Group 1: Tacrolimus from EMS + Myfortic® + Steroids

Treatment:

Drug: Tacrolimus from EMS

Prograf

Active Comparator group

Description:

Group 2: Prograf® + Myfortic® + Steroids

Treatment:

Drug: Prograf