Basiliximab vs Low-dose Thymoglobulin Induction Therapy in Low Risk Kidney Transplant Patients

• Status: Completed
• Trial end date: 2019-07-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coordinación de Investigación en Salud, Mexico
• Treatments: Antibodies, Monoclonal; Basiliximab; Thymoglobulin

Criteria

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.