NCT03088280
Unknown
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Thymoglobulin
- Conditions
- Thymoglobulin Dose
- Sponsor
- Hospital Geral de Fortaleza
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Acute rejection
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Tainá Veras de Sandes Freitas
MD PhD
Hospital Geral de Fortaleza
Eligibility Criteria
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
Arms & Interventions
3mg/kg Group
Patients will received Thymoglobuline 3mg/Kg (reduced dose)
Intervention: Thymoglobulin
6mg/kg Group
Patients will received Thymoglobuline 6mg/Kg (standard dose)
Intervention: Thymoglobulin
Outcomes
Primary Outcomes
Acute rejection
Time Frame: 1 year
Biopsy proven and all treated acute rejection episodes
Secondary Outcomes
- Infection(1 year)
Study Sites (1)
Loading locations...
Similar Trials
Not Yet Recruiting
N/A
Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCLLymphoma, Large B-Cell, DiffuseNCT06289959Second Affiliated Hospital of Soochow University30
Not Yet Recruiting
N/A
Patient Education in the Clinical Management of PessaryPelvic Organ ProlapseNCT06432218Peking Union Medical College Hospital280
Completed
N/A
YAG Vitreolysis for FloatersWeiss RingFloatersPosterior Vitreous DetachmentNCT02897583Ophthalmic Consultants of Boston52
Withdrawn
Phase 1
CD19 and BCMA Targeted Fast Dual CAR-T for CD19+ Refractory/Relapsed B-NHLB-cell LymphomaNCT04877080920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Completed
N/A
The Vertos MILD™ Preliminary Patient Evaluation StudyLumbar Spinal StenosisNCT00749073Vertos Medical, Inc.10