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
Verified date | February 2019 |
Source | Hospital Geral de Fortaleza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Transplant ward of the Hospital do Fortaleza | Fortaleza | Ceará |
Lead Sponsor | Collaborator |
---|---|
Hospital Geral de Fortaleza |
Brazil,
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 |