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

Hospital Geral de Fortaleza

Status and phase: Unknown; Phase 4

Conditions: Thymoglobulin Dose

Treatments: Drug: Thymoglobulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03088280

01

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

3mg/kg Group

Experimental group

Description:

Patients will received Thymoglobuline 3mg/Kg (reduced dose)

Treatment:

Drug: Thymoglobulin

6mg/kg Group

Active Comparator group

Description:

Patients will received Thymoglobuline 6mg/Kg (standard dose)

Treatment:

Drug: Thymoglobulin