ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF

Phase 4TerminatedNCT02056938

Nantes University Hospital19 enrolled

Overview

The primary objective of the following randomized open label trial is to demonstrate how low immunological risk patients (no anti HLA immunization and first kidney transplantation) but diagnosed at high-risk of delayed graft function (assessed by DGFS score) could benefit from induction with ATG for preventing delayed graft function compared to Basiliximab.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Transplantation

Interventions

Anti-Thymocyte Globulins treatmentDRUG

Basiliximab treatmentDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults * First kidney transplantation * No anti HLA immunization prior transplantation * A risk of DGF higher than 40% calculated by the score DGFS (DGFS \>= 0.4) * Written informed consent Exclusion Criteria: * Previous or combined other transplantations * Non heart beating donors * Living donors * Pre-emptive transplantation * Patients on peritoneal dialysis * Leucopenia lower than 3000/mm3 * Thrombopenia lower than 100 000/mm3 * Donor EBV positive / recipient EBV Negative * Pregnant or lactating women * Patients under guardianship * Previous and current history of cancer and/or lymphoma * Current history of HCV or HBV or HIV infection

Locations (4)

Universitary hospital of Lyon

Lyon, France

Nantes Universitary hospital

Nantes, France

Universitary hospital of Nice

Nice, France

Necker Hospital

Paris, France

Outcomes

Primary Outcomes

Occurrence of a delayed graft function

Occurrence of a delayed graft function defined as the need for dialysis within the first seven days post transplantation.

Time frame: 7 days

Secondary Outcomes

Duration of the delayed graft function

Duration of the DGF defined by the number of days after the transplantation to reach an estimated glomerular filtration rate (eGFR) above 10 mL/min. Only eGFR assessments at least 48 hours after the last day of dialysis will be considered.

Time frame: 7 days

Evolution of estimated glomerular filtration rate (eGFR)

Evolution of eGFR from day 1 to day 7 post transplantation then every two days until hospital discharge. Only eGFR assessments at least 48 hours after the last day of dialysis will be considered.

Time frame: 15 days

Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation

Time frame: 3 months

Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge.

Time frame: 15 days

Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis).

Time frame: 3 months

Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR

Time frame: 3 months

Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation.

Data from ClinicalTrials.gov

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