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

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ClinicalTrials.gov Identifier: NCT03006419
Recruitment Status : Recruiting
First Posted : December 30, 2016
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Coordinación de Investigación en Salud, Mexico

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

Condition or disease Intervention/treatment Phase
Kidney Transplant Rejection Kidney Transplant; Complications Drug: Basiliximab Drug: Thymoglobulin Phase 4

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : December 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab

Arm Intervention/treatment
Active Comparator: Group A (Basiliximab group)
Basiliximab (Simulect) induction therapy: 20 mg IV at day of transplant (to be administered 2 hours prior to transplant and up to 4 hours after transplant) and second dosage (20 mg) at fourth day after kidney transplantation.
Drug: Basiliximab
Standard induction therapy
Other Name: Simulect

Experimental: B (Low-dose Thymoglobulin group)
Thymoglobulin induction therapy (1 mg/kg rounded by 25 mg increments) at day of transplant followed by same dosage (1 mg/kg rounded by 25 mg increments) during day 1 and day 2 after transplant in order to complete 3 mg/kg accumulated dose.
Drug: Thymoglobulin
Induction therapy
Other Name: rATG




Primary Outcome Measures :
  1. Biopsy proven acute rejection [ Time Frame: 12 months following transplantation ]
    Acute rejection described by Banff category


Secondary Outcome Measures :
  1. Delayed graft function [ Time Frame: 12 months following transplantation ]
    Dialysis during first week of transplantation

  2. Slow graft function [ Time Frame: 12 months following transplantation ]
    Creatinine clearance < 50% pretransplant during first week of transplantation

  3. Infections [ Time Frame: 12 months following transplantation ]
  4. Hospital admissions [ Time Frame: 12 months following transplantation ]
  5. Graft function [ Time Frame: 12 months following transplantation ]
    Creatinine clearance measured by MDRD-4

  6. Graft loss [ Time Frame: 12 months following transplantation ]
    Return to dialysis

  7. Patient survival [ Time Frame: 12 months following transplantation ]
    Patient Death



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03006419


Contacts
Contact: Gustavo Martinez-Mier, MD 5212299295208 gmtzmier@gmail.com
Contact: Ernesto Soto-Miranda, MD 5212292106793 dr.ernestosoto@gmail.com

Locations
Mexico
Umae Hospital Especialidades 14 Adolfo Ruiz Cortines Recruiting
Veracruz, Mexico, 91897
Contact: GUSTAVO MARTINEZ-MIER, MD    5212299285208    gmtzmier@gmail.com   
Contact: ERNESTO SOTO-MIRANDA, MD    5212292106793    dr.ernestosoto@gmail.com   
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Principal Investigator: Gustavo Martinez-Mier, MD Jefe de División, UMAE 189, Veracruz, Veracruz

Publications of Results:
Other Publications:
Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03006419     History of Changes
Other Study ID Numbers: R-2016-3001-61
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD sharing plan

Keywords provided by Coordinación de Investigación en Salud, Mexico:
kidney transplantation
induction
thymoglobulin
basiliximab
acute rejection
graft loss

Additional relevant MeSH terms:
Thymoglobulin
Antilymphocyte Serum
Basiliximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents