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ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF (PREDICT-DGF)

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ClinicalTrials.gov Identifier: NCT02056938
Recruitment Status : Terminated (recruitment issues)
First Posted : February 6, 2014
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Anti-Thymocyte Globulins treatment Drug: Basiliximab treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : June 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ATG

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).

Drug: Anti-Thymocyte Globulins treatment
Active Comparator: Basiliximab
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).
Drug: Basiliximab treatment



Primary Outcome Measures :
  1. Occurrence of a delayed graft function [ Time Frame: 7 days ]
    Occurrence of a delayed graft function defined as the need for dialysis within the first seven days post transplantation.


Secondary Outcome Measures :
  1. Duration of the delayed graft function [ Time Frame: 7 days ]
    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.

  2. Evolution of estimated glomerular filtration rate (eGFR) [ Time Frame: 15 days ]
    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.

  3. Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation [ Time Frame: 3 months ]
  4. Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge. [ Time Frame: 15 days ]
  5. 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 ]
  6. Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR [ Time Frame: 3 months ]
  7. Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation. [ Time Frame: 3 months ]
  8. Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation [ Time Frame: 3 months ]
    Percentage of renal fibrosis on a surveillance kidney biopsy at 3 months post transplantation will be evaluated by computerized quantification.



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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:

  • 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

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): NCT02056938


Locations
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France
Universitary hospital of Lyon
Lyon, France, 69437
Nantes Universitary hospital
Nantes, France, 44093
Universitary hospital of Nice
Nice, France, 06002
Necker Hospital
Paris, France, 75045
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Magali GIRAL, Professor Nantes universitary hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02056938    
Other Study ID Numbers: RC14_0051
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Keywords provided by Nantes University Hospital:
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
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes
Antilymphocyte Serum
Basiliximab
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents