Clinical trial NCT02056938: ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF
Official title: Prospective Multicentric, Randomized, Open-labeled, in Parallel Groups, Study to Assess the Benefit/Risk of an Induction Treatment With Anti-Thymocyte Globulins (ATG) Versus Basiliximab in Kidney Transplant Patients Displaying Low Immunological Risk But High Susceptibility to Delayed Graft Function.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Transplantation
kidney
delayed graft function
induction therapy
personalized medicine
First kidney transplantation
No anti HLA immunization prior transplantation
Risk of DGF higher than 40% calculated byt he score DGFS
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of a delayed graft function
timeFrame: 7 days
Secondary outcomes:
measure: Duration of the delayed graft function
timeFrame: 7 days
measure: Evolution of estimated glomerular filtration rate (eGFR)
timeFrame: 15 days
measure: Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation
timeFrame: 3 months
measure: Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge.
timeFrame: 15 days
measure: Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis).
timeFrame: 3 months
measure: Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR
timeFrame: 3 months
measure: Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation.
timeFrame: 3 months
measure: Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation
timeFrame: 3 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Universitary hospital of Lyon
city: Nantes
country: France
facility: Nantes Universitary hospital
city: Nice
country: France
facility: Universitary hospital of Nice
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: Nantes universitary hospital
name: Magali GIRAL, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chapal M, Foucher Y, Marguerite M, Neau K, Papuchon E, Daguin P, Morelon E, Mourad G, Cassuto E, Ladriere M, Legendre C, Giral M. PREventing Delayed Graft Function by Driving Immunosuppressive InduCtion Treatment (PREDICT-DGF): study protocol for a randomized controlled trial. Trials. 2015 Jun 23;16:282. doi: 10.1186/s13063-015-0807-x.