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

Kidney Transplant; Complications Clinical Trial

Official title:

Basiliximab vs Reduced Dose Rabbit Antithymocyte Globulin (rRTAG): Evaluation of Efficacy and Safety Outcomes in Low Immunological Risk Living Donor Kidney Transplant: 12-month Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006419
• Other study ID #: R-2016-3001-61
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2016
• Est. completion date: July 30, 2019

Study information

• Verified date: December 2018
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Rejection
• Kidney Transplant; Complications

Intervention

Drug:
• Basiliximab
Standard induction therapy
• Thymoglobulin
Induction therapy

Locations

Country	Name	City	State
Mexico	Umae Hospital Especialidades 14 Adolfo Ruiz Cortines	Veracruz

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

Brennan DC, Daller JA, Lake KD, Cibrik D, Del Castillo D; Thymoglobulin Induction Study Group. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med. 2006 Nov 9;355(19):1967-77. — View Citation

Gaber AO, Matas AJ, Henry ML, Brennan DC, Stevens RB, Kapur S, Ilsley JN, Kistler KD, Cosimi AB; Thymoglobulin Antibody Immunosuppression in Living Donor Recipients Investigators. Antithymocyte globulin induction in living donor renal transplant recipient — View Citation

Hardinger KL, Schnitzler MA, Koch MJ, Labile E, Stirnemann PM, Miller B, Enkvetchakul D, Brennan DC. Thymoglobulin induction is safe and effective in live-donor renal transplantation: a single center experience. Transplantation. 2006 May 15;81(9):1285-9. — View Citation

Laftavi MR, Alnimri M, Weber-Shrikant E, Kohli R, Said M, Patel S, Pankewycz O. Low-dose rabbit antithymocyte globulin versus basiliximab induction therapy in low-risk renal transplant recipients: 8-year follow-up. Transplant Proc. 2011 Mar;43(2):458-61. doi: 10.1016/j.transproceed.2011.01.035. — View Citation

Schenker P, Ozturk A, Vonend O, Krüger B, Jazra M, Wunsch A, Krämer B, Viebahn R. Single-dose thymoglobulin induction in living-donor renal transplantation. Ann Transplant. 2011 Apr-Jun;16(2):50-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsy proven acute rejection	Acute rejection described by Banff category	12 months following transplantation
Secondary	Delayed graft function	Dialysis during first week of transplantation	12 months following transplantation
Secondary	Slow graft function	Creatinine clearance < 50% pretransplant during first week of transplantation	12 months following transplantation
Secondary	Infections	Presence of a positive culture of any microorganism in presence of clinical symptoms	12 months following transplantation
Secondary	Hospital admissions	Admission to the hospital for at least 24 hours	12 months following transplantation
Secondary	Graft function	Creatinine clearance measured by MDRD-4	12 months following transplantation
Secondary	Graft loss	Return to dialysis	12 months following transplantation
Secondary	Patient survival	Patient Death	12 months following transplantation