Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen
NCT03088280 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2019-02-22
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.
Conditions
- Thymoglobulin Dose
Interventions
- DRUG
-
Thymoglobulin
reduced dose (3mg/Kg)
Sponsors & Collaborators
-
Hospital Geral de Fortaleza
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2018-01-10
- Completion
- 2020-01-31
Countries
- Brazil
Study Locations
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