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.

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 Overview

• Status: Terminated
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Anti-Thymocyte Globulins treatment; Drug: Basiliximab treatment

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69437
    • Universitary hospital of Lyon
  • Nantes, France, 44093
    • Nantes Universitary Hospital
  • Nice, France, 06002
    • Universitary hospital of Nice
  • Paris, France, 75045
    • Necker Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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
Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR		3 months
Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation.		3 months
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.	3 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Magali GIRAL, Professor, Nantes Universitary Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: February 5, 2014
• First Posted (Estimate): February 6, 2014

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Transplantation; kidney; personalized medicine; induction therapy; delayed graft function; First kidney transplantation; No anti HLA immunization prior transplantation; Risk of DGF higher than 40% calculated byt he score DGFS
• Additional Relevant MeSH Terms: Pathologic Processes; Delayed Graft Function; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Basiliximab; Antilymphocyte Serum
• Other Study ID Numbers: RC14_0051