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Kidney TransplantationPhase 4PREDICT-DGFNCT02056938

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

A Phase 4 study testing Anti-Thymocyte Globulins treatment and Basiliximab treatment in people with Kidney Transplantation, run by Nantes University Hospital at 4 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplantation
What is being tested?
Anti-Thymocyte Globulins treatment and Basiliximab treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
4 sitesFrance
Study dates
Jun 2014to Feb 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Previous or combined other transplantations
  • Non heart beating donors
  • Living donors
  • Pre-emptive transplantation
  • Patients on peritoneal dialysis
  • Leucopenia lower than 3000/mm3
Show all 12Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Universitary hospital of Lyon

    Lyon, 69437

  • Nantes Universitary hospital

    Nantes, 44093

  • Universitary hospital of Nice

    Nice, 06002

  • Necker Hospital

    Paris, 75045

Other trials in France

About this study

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.

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.

Being tested
Anti-Thymocyte Globulins treatment, Basiliximab treatment
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
Medical subject headings
Delayed Graft Function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-Thymocyte Globulins treatmentDrug

  • Basiliximab treatmentDrug

Study groups in NCT02056938
Study groupRoleWhat they receive
ATGExperimentalThe 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).
Receives: Drug: Anti-Thymocyte Globulins treatment
BasiliximabActive 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).
Receives: Drug: Basiliximab treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 days

Secondary outcomes (8)

  1. 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.

    Measured: 7 days

  2. 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.

    Measured: 15 days

  3. Number of dialysis procedures performed after transplantation without taking into account the dialysis due to hyperkaliemia and/or hyperhydratation

    Measured: 3 months

  4. Evolution of Tacrolimus levels (T0) from Day 1 to Day 7 post transplantation then every 2 days until hospital discharge.

    Measured: 15 days

  5. Hematologic effect within the first 3 months of surgery (WBC monitoring, CD3, CD4, CD8, CD19, NK and platelet sub population analysis).

    Measured: 3 months

  6. Occurrence of infections within the first 3 months post transplantation, especially the CMV and BK reactivation assessed by RTPCR

    Measured: 3 months

  7. Occurrence of biopsy-confirmed acute rejection episodes and subclinical acute rejection episodes within the first 3 months post transplantation.

    Measured: 3 months

  8. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Why it stopped: recruitment issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02056938
Sponsor's protocol ID
RC14_0051
Acronym
PREDICT-DGF
Status last verified
Nov 2017
First submitted
5 Feb 2014
Last updated
21 Nov 2017
Results posted
No
Data monitoring committee
No

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.

    PubMed 26099226

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Anti-Thymocyte Globulins treatment and Basiliximab treatment in people with Kidney Transplantation, run by Nantes University Hospital at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: recruitment issues). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of a delayed graft function (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02056938, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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