A Randomized Study Assess the Safety and Efficacy of Tacrolimus vs Prograf® in Renal Transplantation Treatment
Information source: EMS
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Transplant
Intervention: Tacrolimus from EMS (Drug); Prograf (Drug)
Phase: Phase 3
Status: Suspended
Sponsored by: EMS Official(s) and/or principal investigator(s): Felipe Pinho, MD, Study Director, Affiliation: EMS
Summary
Comparison of safety and efficacy of immunosuppressive regiments using tacrolimus from EMS
and Prograf® in post renal transplanted patients.
Clinical Details
Official title: An Open Randomized Non-inferiority Study to Compare Safety and Efficacy of Immunosuppressive Regiments Using Tacrolimus From EMS and Prograf® in Post Renal Transplanted Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Efficacy
Secondary outcome: Safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, RS 90020090, Brazil
Additional Information
Starting date: May 2014
Last updated: March 1, 2013
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