| Trial name or title |
Prevention in recipients with Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG‐F versus basiliximab as induction immunosuppressive treatment (PIRAT) |
| Methods |
Parallel RCT |
| Participants |
Setting: multicentre Country: France Patients 18 to 75 years with diagnosis of native kidney primary IgA GN biopsy‐proven; first kidney transplantation (one kidney) Number: 115 participants planned Mean age ± SD (years): not yet available Sex (M/F): not yet available Exclusion criteria: 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 GN secondary to HSP or 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: TB, 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/μL); bacterial infection, viral and fungal uncontrolled therapeutically; pregnancy or lactation |
| Interventions |
Treatment group 1
Rabbit immunoglobulin antilymphocyte human T (ATG‐Fresenius®): administered by slow infusion over 4 hours after antihistamine (2 bulbs Polaramine® IV) and IV methylprednisolone (minimum 30 mg); it is started on day 0 prior to surgery at doses of 4 mg/kg, and then continued to day 1, day 2 to 4 mg/kg, then day 3, day 4 at the dose of 3 mg/kg
Treatment group 2
|
| Outcomes |
|
| Starting date |
January 2011 |
| Contact information |
Principal Investigator: Francois Berthoux |
| Notes |
Estimated study completion date: December 2019
No study results available
Sponsor: Centre Hospitalier Universitaire de Saint Etienne |
