Study Stopped
recruitment issues
ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF
PREDICT-DGF
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.
1 other identifier
interventional
19
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2014
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2014
CompletedFirst Posted
Study publicly available on registry
February 6, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedNovember 21, 2017
November 1, 2017
2.7 years
February 5, 2014
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
7 days
Secondary Outcomes (8)
Duration of the delayed graft function
7 days
Evolution of estimated glomerular filtration rate (eGFR)
15 days
Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation
3 months
Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge.
15 days
Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis).
3 months
- +3 more secondary outcomes
Study Arms (2)
ATG
EXPERIMENTALThe 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).
Basiliximab
ACTIVE COMPARATORThe 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Universitary hospital of Lyon
Lyon, 69437, France
Nantes Universitary hospital
Nantes, 44093, France
Universitary hospital of Nice
Nice, 06002, France
Necker Hospital
Paris, 75045, France
Related Publications (1)
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.
PMID: 26099226DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magali GIRAL, Professor
Nantes universitary hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2014
First Posted
February 6, 2014
Study Start
June 1, 2014
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
November 21, 2017
Record last verified: 2017-11