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Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment (PIRAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02523768
Recruitment Status : Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Brief Summary:

IgA nephropathy (IgAN) is a histologically defined glomerulonephritis (renal biopsy) by the presence of deposits immunoglobulin A (IgA) in the renal mesangium (at least 1+) by immunofluorescence. The clinic allows excluding secondary forms (10-15%). Recurrence of this condition on the renal graft is time-dependent and confirmed in 25 to 50% of 10 years post-transplant.

The primary immunosuppressive induction regimens currently used in kidney transplantation are the anti-lymphocyte globulin (GAL) whose main target is human T lymphocytes (ATG, polyclonal) and monoclonal anti-CD25 antibodies (α chain of the interleukin receptor 2 in the surface of T lymphocytes). Due to their potent and prolonged immunosuppressive properties, the ATG may prevent or delay the recurrence on renal transplant.

The aim of this study was to evaluate the influence of induction therapy (ATG versus Basiliximab) in the cumulative incidence at 5 years of (IgAN) recurrence after a first kidney transplant.

This is a prospective, multicenter, randomized, open trial with a follow-up period of 5 years old.

Patients in the ATG arm will receive 5 antilymphocyte globulin infusions Fresenius® (rabbit immunoglobulin antilymphocyte human T-Fresenius® said ATG) from Day 0 to Day + 4 post-transplant (day 0 one dose of 4mg / kg, day 1 one dose of 4mg/kg, day2 one dose of 4mgkg, day 3 one dose of 3 m/kg and day 4 and one final dose of 3 mg/kg) and the patients in the anti-CD25 arm will receive 2 doses of 20 mg of basiliximab (Simulect®) pn day 0 and day 4 after the graft. The maintenance immunosuppressive therapy is left to the discretion of the center.

The primary endpoint will be the clinical and histological recurrence of IgAN defined by the presence of mesangial deposits of IgA (at least 1) by immunofluorescence on a biopsy of the graft triggered by the onset of proteinuria 1g/j and/or microalbuminuria greater than 300 mg / day.


Condition or disease Intervention/treatment Phase
Glomerulonephritis IgAN Drug: ATG-F Drug: Simulect Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment
Actual Study Start Date : January 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab

Arm Intervention/treatment
Experimental: ATG-F
The ATG-Fresenius® is administered by slow infusion over four hours after antihistamine (2 bulbs Polaramine® IV) and intravenous methylprednisolone (minimum 30mg); it is started on day 0 prior to surgery at doses of 4 mg / kg, and then continued to day 1, day 2 to 4mg / kg, then day 3, day 4 at the dose of 3 mg / kg
Drug: ATG-F
Active Comparator: Simulect
The anti CD25 (basiliximab, Simulect®) is administered intravenously before surgery of renal transplantation (Day 0 and Day + 4 (1 ampoule of 20 mg x 2 times).
Drug: Simulect



Primary Outcome Measures :
  1. clinical recurrence [ Time Frame: 5 years ]
    onset of proteinuria 1g / j and / or microalbuminuria greater than 300 mg / day

  2. histological recurrence [ Time Frame: 5 years ]
    histological recurrence defined by the presence of mesangial deposits of IgA (at least 1+) by immunofluorescence on a biopsy of the graft



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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:

  • Free, informed, express and written.
  • Diagnosis of native kidney primary IgA glomerulonephritis biopsy-proven
  • First kidney transplantation (one kidney)

Exclusion Criteria:

  • Panel Reactive Antibody (PRA PRA global or class I or class II PRA) over 50% on a serum before transplantation
  • Multi-organ graft
  • Transplants using donor limits or sub-optimal: donor age ≥ 70 years, donors in the study BIGRAS or taken heart beating donors (tested on computer infusion) or other restriction factors
  • IgA glomerulonephritis secondary to HSP (Henoch-Schonlein purpura) or Systemic Lupus Erythematosus (SLE) or alcoholic cirrhosis
  • History of cancer older than 5 years or with advanced cancer, but except for non-recurrent skin cancers
  • Infectious diseases scalable: tuberculosis, HIV, Hepatitis B virus or Hepatitis C virus infection with viral replication and / or chronic hepatitis
  • Allergy to rabbit proteins
  • Severe thrombocytopenia (<50,000 platelets/ul)
  • Bacterial infection, viral and fungal uncontrolled therapeutically
  • Pregnancy or lactation

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): NCT02523768


Locations
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France
CHU de BESANCON
Besancon, France, 25000
CHU de BORDEAUX
Bordeaux, France, 33000
Chu Kremlin Bicetre
Le Kremlin Bicetre, France, 94275
Hopital Edouard HERRIOT
Lyon, France, 69000
CHU de MONTPELLIER
Montpellier, France, 34000
CHU de NANCY
Nancy, France, 54000
CHU de NANTES
Nantes, France, 44000
CHU de NICE
Nice, France, 06000
Hopital Pitie Salpetriere
Paris, France, 75013
Hopital Tenon
Paris, France, 75970
Hopital LYON Sud
Pierre Benite, France, 69310
CHU de SAINT-ETIENNE
Saint-etienne, France, 42000
CHU de STRASBOURG
Strasbourg, France, 67000
CHU de TOULOUSE
Toulouse, France, 31000
CHRU de TOURS
Tours, France, 37000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Francois BERTHOUX, MD PhD CHU de SAINT-ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02523768    
Other Study ID Numbers: 0908143
2009-018189-36 ( EudraCT Number )
A100405-32 ( Other Identifier: AFSSAPS )
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glomerulonephritis, IGA
Glomerulonephritis
Recurrence
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Nephritis
Autoimmune Diseases
Immune System Diseases
Basiliximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs