Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen

Thymoglobulin Dose Clinical Trial

Official title:

Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg vs. 6mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03088280
• Other study ID #: 01
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: June 30, 2015
• Est. completion date: January 2020

Study information

• Verified date: February 2019
• Source: Hospital Geral de Fortaleza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: January 2020
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Primary kidney transplant recipients, adults

Exclusion Criteria:

• PRA > 50%

• DSA > 1500 MFI

• Retransplantation

• Patients who are planning to receive mycophenolate instead of everolimus

• Patients who have planning for follow-up in another center

Related Conditions & MeSH terms

• Thymoglobulin Dose

Intervention

Drug:
• Thymoglobulin
reduced dose (3mg/Kg)

Locations

Country	Name	City	State
Brazil	Transplant ward of the Hospital do Fortaleza	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Geral de Fortaleza

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute rejection	Biopsy proven and all treated acute rejection episodes	1 year
Secondary	Infection	All infections requiring hospitalization	1 year