Kidney Replacement Clinical Trial
— ONSETOfficial title:
Basiliximab With One Day or Seven Days RATG Induction Therapy in Renal Transplantation: a Matched-cohort Observational Study
NCT number | NCT06374095 |
Other study ID # | ONSET |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | June 2025 |
This trial is to compare the risk/benefit profile over six-month follow-up of two induction immunosuppressive regimens based on one or seven low-dose perioperative RATG infusions on top of the same induction therapy with basiliximab and steroid (progressively tapered post-transplant) and maintenance therapy with calcineurin inhibitors and mycophenolate mofetil/mycophenolic acid in 75 recipients (25 Patients and 50 Reference-Patients) of a single or dual first kidney transplant from an ideal or marginal donor at a single Renal Transplant Center.
Status | Not yet recruiting |
Enrollment | 75 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Consecutive recipients of a single or dual kidney transplant from ideal or marginal donors who, from 01/04/2023 to 31/12/2023, were induced with one single perioperative RATG infusion - Consecutive recipients (Reference-Patients) of a single or dual kidney transplant from ideal or marginal donors who before 01/04/2023 were induced with seven perioperative RATG infusions (on top of the same induction and maintenance treatment used for patients receiving one single RATG infusion) Exclusion Criteria: - Living donor recipients, second transplant recipients or patients receiving a multiorgan transplant, and patients with a peak panel reactive antibody titer >30% or positive B cell cross-match |
Country | Name | City | State |
---|---|---|---|
Italy | ASST HPG23 - Unità di Nefrologia | Bergamo | BG |
Lead Sponsor | Collaborator |
---|---|
Mario Negri Institute for Pharmacological Research |
Italy,
Lebranchu Y, Bridoux F, Buchler M, Le Meur Y, Etienne I, Toupance O, Hurault de Ligny B, Touchard G, Moulin B, Le Pogamp P, Reigneau O, Guignard M, Rifle G. Immunoprophylaxis with basiliximab compared with antithymocyte globulin in renal transplant patients receiving MMF-containing triple therapy. Am J Transplant. 2002 Jan;2(1):48-56. doi: 10.1034/j.1600-6143.2002.020109.x. — View Citation
Remuzzi G, Lesti M, Gotti E, Ganeva M, Dimitrov BD, Ene-Iordache B, Gherardi G, Donati D, Salvadori M, Sandrini S, Valente U, Segoloni G, Mourad G, Federico S, Rigotti P, Sparacino V, Bosmans JL, Perico N, Ruggenenti P. Mycophenolate mofetil versus azathioprine for prevention of acute rejection in renal transplantation (MYSS): a randomised trial. Lancet. 2004 Aug 7-13;364(9433):503-12. doi: 10.1016/S0140-6736(04)16808-6. — View Citation
Thiyagarajan UM, Ponnuswamy A, Bagul A. Thymoglobulin and its use in renal transplantation: a review. Am J Nephrol. 2013;37(6):586-601. doi: 10.1159/000351643. Epub 2013 Jun 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of thrombocytopenia and/or leukopenia | Incidence of thrombocytopenia and/or leukopenia requiring or not requiring down-titration or transient withdrawal of mycophenolate mofetil/ mycophenolic acid (and/or RATG) | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Occurrence of anemia | Occurrence of anemia requiring treatment with erythropoiesis stimulating agents | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Occurrence of viral infections | Polyomavirus BK (BKV) and/or Cytomegalovirus (CMV) infection/reactivations | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Occurrence of pneumonia | Pneumocystis carinii pneumonia | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Occurrence of opportunistic infections | Systemic candidiasis and any other opportunistic infection | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Occurrence of delayed graft function | Delayed Graft Function defined as need of dialysis during the first week post-transplant | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Occurrence of allograft rejection | Acute allograft rejection (overall, steroid-resistant and biopsy-proven rejections considered separately) | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Occurrence of biopsy proven rejection | Banff score for biopsy proven rejections | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Survival | Six-month patient/graft survival | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Platelet and WBC counts | Six-month time course of platelet and WBC counts | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Creatinine levels | Six-month time course of serum creatinine levels | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months | |
Secondary | Adverse events | Incidence of serious and non-serious adverse events | From day 0 post-transplant up to 10 days or patient discharge, then at 2, 3 and 4 weeks post-transplant and every 1 month up to 12 months |
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