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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

Page last updated: August 23, 2015

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