Kidney Transplant; Complications, Kidney Transplant Rejection
Conditions
Keywords
kidney transplantation, induction, thymoglobulin, basiliximab, acute rejection, graft loss
Brief summary
Demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction
Detailed description
Introduction: The TAILOR study in living donor kidney transplantation demonstrated a 98% one year patient and graft survival and 91% and 83% at 5 years with rejection-free patients in 93%. The cumulative dose of r ATG (thymoglobulin) was 5.29 mg / kg with 3% adverse effects and almost 50% steroid free at 12 months. Others have explored the benefit of low doses of r ATG (thymoglobulin) (3-5 mg / kg) against Basiliximab in low-risk population and demonstrated in living donor recipients with 8 year follow-up similar survival rates with a lower BPAR rate in rATG (thymoglobulin) (p \<0.05) and better serum creatinine in 3 and 5 years. The aim of the study was to demonstrate that low dose (3 mg/kg total ) rATG (thymoglobulin) has similar efficacy (delayed graft function, slow graft function, biopsy proven acute rejection episodes, infections, hospitalizations, adverse events, graft loss and death) than Basiliximab induction. Material and methods: Prospective randomized study of patients undergoing renal transplantation who wish to participate. 100 patients who meet the inclusion and exclusion criteria at the time of transplantation will be randomized Experimental and reference therapy: Group A: Induction with Basiliximab 20 mg IV day 0 and day 4 Group B: rATG (Thymoglobulin) 1 mg / kg body weight per day for days 0, 1 and 2 up to a total dose of 3 mg / kg day. According to protocol administration, if there are conditions to delay administration (WBC\<2000 / mm3 and / or platelets \<75,000 / mm3) (17), administration may be postponed until day 7 posttransplant Posttransplant immunosuppression: Tacrolimus, mycophenolate mofetil and steroids Outcome measures (12 months) delayed graft function slow graft function biopsy proven acute rejection episodes infections hospitalizations adverse events graft loss death
Interventions
DRUGBasiliximab
Standard induction therapy
DRUGThymoglobulin
Induction therapy
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female graft recipients older than 18 years of age. * Informed consent to participate in the study. * First living donor kidney transplant recipient. * Negative pregnancy test if female participant
Exclusion criteria
* Second or more kidney transplant. * Multiple organ transplant recipients. * ABO incompatibility or positive cross-over test prior to transplantation. * Antibody Reactive Panel (PRA) \> 30%. * Positive specific donor antibodies (DSA). * Human immunodeficiency virus (HIV) positive patients. * HBsAg or HCV positive. * Severe lung disorders. * Severe allergies receiving treatment that prevent patient's rRTAG administration. * Leukocyte count below 2000 / mm3. * Platelet count below 75,000 / mm3. * History of malignant disease of any organ system (except skin basal cell carcinoma) within the last 5 years, regardless of local recurrence or metastasis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biopsy proven acute rejection | 12 months following transplantation | Acute rejection described by Banff category |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slow graft function | 12 months following transplantation | Creatinine clearance \< 50% pretransplant during first week of transplantation |
| Infections | 12 months following transplantation | Presence of a positive culture of any microorganism in presence of clinical symptoms |
| Hospital admissions | 12 months following transplantation | Admission to the hospital for at least 24 hours |
| Delayed graft function | 12 months following transplantation | Dialysis during first week of transplantation |
| Graft loss | 12 months following transplantation | Return to dialysis |
| Patient survival | 12 months following transplantation | Patient Death |
| Graft function | 12 months following transplantation | Creatinine clearance measured by MDRD-4 |
Countries
Mexico
Outcome results
None listed