ATG Versus Basiliximab in Kidney Transplant Displaying Low Immunological Risk But High Susceptibility to DGF

Kidney Transplantation Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02056938
• Other study ID #: RC14_0051
• Status: Terminated
• Phase: Phase 4
• First received: February 5, 2014
• Last updated: November 17, 2017
• Start date: June 2014
• Est. completion date: February 2017

Study information

• Verified date: November 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delayed Graft Function
• Disease Susceptibility
• Kidney Transplantation

Intervention

Drug:
• Anti-Thymocyte Globulins treatment

• Basiliximab treatment

Locations

Country	Name	City	State
France	Universitary hospital of Lyon	Lyon
France	Nantes Universitary hospital	Nantes
France	Universitary hospital of Nice	Nice
France	Necker Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation		3 months
Secondary	Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge.		15 days
Secondary	Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis).		3 months
Secondary	Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR		3 months
Secondary	Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation.		3 months
Secondary	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