Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment (PIRAT)
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| ClinicalTrials.gov Identifier: NCT02523768 |
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Recruitment Status :
Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : July 23, 2020
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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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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
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Drug: ATG-F |
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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).
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Drug: Simulect |
- clinical recurrence [ Time Frame: 5 years ]onset of proteinuria 1g / j and / or microalbuminuria greater than 300 mg / day
- 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 |
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
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
| 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 | |
| Principal Investigator: | Francois BERTHOUX, MD PhD | CHU de SAINT-ETIENNE |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |