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Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure (DESYRE)

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ClinicalTrials.gov Identifier: NCT01817504
Recruitment Status : Recruiting
First Posted : March 25, 2013
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Our hypothesis is early and systematic transplantectomy under a well-conducted immunosuppression is associated with a decreased risk of anti-HLA immunization against a conservative attitude including a gradual reduction of immunosuppression, with or without a transplantectomy performed for cause (clinical event).

Observation or Investigation Method Used :

The study is :

  • multicenter
  • prospective
  • open
  • randomized: patients are divided into two parallel groups:

    • study group: transplantectomy within six weeks after return to dialysis, antiproliferatives stop at the start of dialysis, Maintenance anticalcineurin-based-immunosuppression without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of anticalcineurin two weeks after transplantectomy. Corticosteroids: 5mg per day until one month after transplantectomy then stop within one month.
    • control group: No systematic transplantectomy. Antiproliferatives stop at the start of dialysis.Anticalcineurins half dose for 3 months, ¼ dose for 3 months and then stop. Corticosteroids:5 mg per day for 6 months, and then tapered and stop within 3 months.

In the case of transplantectomy for cause in the control group, immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later,similary to systematic transplantectomy.


Condition or disease Intervention/treatment Phase
Renal Transplantation Procedure: Systematic transplantectomy Procedure: Progressive reduction of immunosuppression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Interest of Systematic Transplantectomy Versus Conventional Care After Kidney Graft Failure
Actual Study Start Date : March 2013
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Arm Intervention/treatment
Active Comparator: Study group
The study group corresponds to systematic transplantectomy under immunosuppressive therapy within two months after return to dialysis,
Procedure: Systematic transplantectomy
Transplantectomy within two months after return to dialyse. Antiproliferatives stop at the start of dialysis. Maintenance basic immunosuppressive treatment without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of the basic immunosuppressive treatment ttwo weeks after transplantectomy. Maintenance corticosteroids at 5mg per day until one month after transplantectomy then stop corticosteroids within one month.

Control group
The control group corresponds to progressive reduction of immunosuppression without systematic transplantectomy after return to dialysis
Procedure: Progressive reduction of immunosuppression

Progressive reduction of immunosuppression. Transplantectomy for cause only. Antiproliferatives withdrawn at the start of dialysis. Maintenance of anticalcineurin or mTOR inhibitors half dose for 3 months, ¼ dose for 3 months and then stop. Maintenance corticosteroids for 6 months up to 5 mg per day, and then soft stop in 3 months.

In case of transplantectomy by reason in the control group, basic immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later, similary to the strategy used in the study group.





Primary Outcome Measures :
  1. Anti HLA Immunization assessed by Luminex assay [ Time Frame: 12 months (M12) ]

    Evaluate the interest of a transplantectomy early (<2 months after return to dialysis) and systematic under immunosuppressive in renal transplant patients after loss of renal graft function in terms of anti-HLA immunization (measured by Luminex test) a year after loss of renal graft function and return to dialysis in the renal transplant patient.

    Proportion of patients who developed HLA immunization (DSA)after systematic transplantectomy under immunosuppression versus progressive reduction of immunosuppression without transplantectomy



Secondary Outcome Measures :
  1. Kinetics anti-HLA antibodies after transplantectomy [ Time Frame: 12 months after inclusion ]
    Determine the kinetics of new onset anti-HLA antibodies at D0, D15, D30, M3, M6, M9 after systematic or for cause transplantectomy and in the year following graft failure and the proportion of immunized patients during the first 6 months after dialysis. HLA antibodies will be assessed by Luminex test. The specificity of antibodies against HLA I or HLA II will be determined, as well as Mean Immunofluorescence Intensity in each case.

  2. Morbidity and mortality after transplantectomy [ Time Frame: 12 months after inclusion ]
    Determine the morbidity and mortality after transplantectomy according to its indication, systematic or for cause (transplantectomy indications in the control group: persistent pain graft, unexplained fever, hematuria, inflammation or unexplained anemia ).

  3. Measuring the impact of systematic transplantectomy on mortality, inflammation, nutritional status, anemia, hypertension and cardiovascular risk factors [ Time Frame: 12 months ]
    The following parameters will be measured at D0, M1, M3, M6, M9 and M12 after return to dialysis during the first year after kidney graft failure: CRP, pre-albuminemia, albuminemia, BMI, hemoglobin, hematocrit, blood pressure, cholesterol, LDL cholesterol and triglyceride.

  4. Infectious comorbidity [ Time Frame: 12 months ]
    The impact of early cessation of immunosuppression on infectious complications after kidney graft failure will assessed. For each patient, origin of infection, bacterial, viral, fungal, will determined. The total number of infection episodes during the first year will be analyzed in the two groups.

  5. Costs of two strategies [ Time Frame: 12 months after inclusion ]
    To evaluate the medico-economic impact of each conservation strategy in the management of patients who return to dialysis



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 Years.
  • Patients affiliated to health protection system, social security in France or any similar regimen.
  • Renal transplant patient with end-stage transplantation, regardless of the number of previous transplants.
  • Patient receiving immunosuppressive protocol based on anticalcineurin or mTOR inhibitors
  • Patient should have resume hemodialysis within 4 weeks
  • Duration of transplantation more than one year
  • Patient with asymptomatic graft
  • immunogenic potential residual >50% (calculated PIR during the re-dialysis)
  • Patient not covered by any measure of legal protection.

Exclusion Criteria:

  • Immunogenic potential residual <50%
  • Graft infection uncontrolled by treatment
  • Active infectious pathology
  • Inflammatory graft
  • Uncontrolled arterial hypertention
  • Inflammatory syndrome of undetermined origin with CRP>50mg/l
  • Fever of unknown origin for more than 8 days T>38°C
  • Contra-indication to surgery
  • AVK treatment
  • Patient candidate for a living donor within 12 months
  • Monotherapy with calcineurin inhibitors or mTOR inhibitors
  • Treatment directed against the humoral response in the 6 months preceding the recovery of dialysis (Rituximab IV-Ig or high doses)
  • Presence of another transplant (pancreas, liver, heart, lung)

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): NCT01817504


Contacts
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Contact: Emmanuel MORELON, MD 472 110 150 ext +33 emmanuel.morelon@chu-lyon.fr

Locations
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Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Emmanuel MORELON, MD Transplantation Department, Hopital Edouard Herriot, Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01817504    
Other Study ID Numbers: 2012.714
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: December 3, 2020
Last Verified: December 2020
Keywords provided by Hospices Civils de Lyon:
Renal failure,
Transplantectomy
Immunosuppression
Sensitization