Back to resultsATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF (PREDICT-DGF)
Primary Purpose
Kidney Transplantation
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Anti-Thymocyte Globulins treatment
Basiliximab treatment
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Transplantation focused on measuring 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
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
Sites / Locations
- Universitary hospital of Lyon
- Nantes Universitary hospital
- Universitary hospital of Nice
- Necker Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ATG
Basiliximab
Arm Description
The first infusion of Thymoglobuline® begins before the kidney reperfusion. In case of a patient with a functional arteriovenous fistula or a high-flow venous catheter, the infusion of Thymoglobuline® can begin just after the randomization pre operatively. When the patient has no available arteriovenous fistula for the Thymoglobuline® infusion, it is necessary to install a high-flow vein (central vein) by the anesthesiologist, and to begin the perfusion as soon as possible intra-operatively before the reperfusion of the kidney. The dose of Thymoglobuline® per infusion is 1.5mg/kg. The duration of each infusion is between 6 to 24 hours. The total duration of the Thymoglobuline® administration is 4 days (starting at and including the first day of the surgery).
The first infusion of Simulect® begins within the two hours before the surgery. There is no need of central venous catheter or arteriovenous fistula to infuse the Simulect®. The duration of the infusion is 30 minutes. Each dose of Simulect® is 20 mg. The first infusion of Simulect® is displayed on Day 0 (within the two hours before the surgery) and the second infusion 3 days afterward (Day 4).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation
Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge.
Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis).
Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR
Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation.
Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation
Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation will be evaluated by computerized quantification.
Full Information
NCT ID
NCT02056938
First Posted
February 5, 2014
Last Updated
November 17, 2017
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02056938
Brief Title
ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF
Acronym
PREDICT-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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
recruitment issues
Study Start Date
June 2014 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATG
Arm Type
Experimental
Arm Description
The first infusion of Thymoglobuline® begins before the kidney reperfusion. In case of a patient with a functional arteriovenous fistula or a high-flow venous catheter, the infusion of Thymoglobuline® can begin just after the randomization pre operatively. When the patient has no available arteriovenous fistula for the Thymoglobuline® infusion, it is necessary to install a high-flow vein (central vein) by the anesthesiologist, and to begin the perfusion as soon as possible intra-operatively before the reperfusion of the kidney. The dose of Thymoglobuline® per infusion is 1.5mg/kg. The duration of each infusion is between 6 to 24 hours.
The total duration of the Thymoglobuline® administration is 4 days (starting at and including the first day of the surgery).
Arm Title
Basiliximab
Arm Type
Active Comparator
Arm Description
The first infusion of Simulect® begins within the two hours before the surgery. There is no need of central venous catheter or arteriovenous fistula to infuse the Simulect®. The duration of the infusion is 30 minutes. Each dose of Simulect® is 20 mg. The first infusion of Simulect® is displayed on Day 0 (within the two hours before the surgery) and the second infusion 3 days afterward (Day 4).
Intervention Type
Drug
Intervention Name(s)
Anti-Thymocyte Globulins treatment
Intervention Type
Drug
Intervention Name(s)
Basiliximab treatment
Primary Outcome Measure Information:
Title
Occurrence of a delayed graft function
Description
Occurrence of a delayed graft function defined as the need for dialysis within the first seven days post transplantation.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Duration of the delayed graft function
Description
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
Title
Evolution of estimated glomerular filtration rate (eGFR)
Description
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
Title
Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation
Time Frame
3 months
Title
Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge.
Time Frame
15 days
Title
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
Title
Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR
Time Frame
3 months
Title
Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation.
Time Frame
3 months
Title
Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation
Description
Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation will be evaluated by computerized quantification.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magali GIRAL, Professor
Organizational Affiliation
Nantes universitary hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitary hospital of Lyon
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Nantes Universitary hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Universitary hospital of Nice
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75045
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26099226
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.
Results Reference
derived
Learn more about this trial
ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF
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