1 vs 7 RATG Infusions in Renal Transplantation
NCT06374095 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 75
Last updated 2025-09-04
Summary
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.
Conditions
- Kidney Replacement
Interventions
- DRUG
-
RATG
Thymoglobulin, Genzyme corporation, Italy.
- DRUG
-
Basiliximab
Simulect, Novartis, Italy.
Sponsors & Collaborators
-
Mario Negri Institute for Pharmacological Research
lead OTHER
Principal Investigators
-
Giuseppe Remuzzi, MD · Istituto Di Ricerche Farmacologiche Mario Negri
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-30
- Primary Completion
- 2025-09-30
- Completion
- 2025-09-30
Countries
- Italy
Study Locations
More Related Trials
-
Evaluation of Desensitization Protocols in HLA-incompatible Kidney-transplant Candidates
NCT03507348 ·Status: TERMINATED ·Phase: NA
-
Antithymocyte Globulin and Azathioprine Versus Basiliximab and Mycophenolate Mofetil in Living Donor Kidney Transplantation
NCT03789006 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
NCT01820572 ·Status: COMPLETED ·Phase: PHASE3
-
Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
NCT00842699 ·Status: COMPLETED
-
Phase IV Study to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation
NCT00724022 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Evaluate the Combination of Enteric-coated Mycophenolate Sodium (EC-MPS), Basiliximab, and C2-monitored Cyclosporine in de Novo Renal Transplant Recipients at Potential High Risk of Delayed Graft Function (DGF)
NCT00154232 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy, Safety, Tolerability and Pharmacokinetic (PK) Study of GSK1070806 for the Prevention of Delayed Graft Function (DGF) in Adult Subjects After Renal Transplantation
NCT02723786 ·Status: TERMINATED ·Phase: PHASE2
-
Study Evaluating Sirolimus in Kidney Transplant Recipients.
NCT00167947 ·Status: COMPLETED ·Phase: PHASE3
-
A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients
NCT00369161 ·Status: COMPLETED ·Phase: PHASE4
-
Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome
NCT03794492 ·Status: COMPLETED ·Phase: PHASE4
-
An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.
NCT00343226 ·Status: COMPLETED ·Phase: PHASE4
-
Belatacept Early Steroid Withdrawal Trial
NCT01729494 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
NCT01324934 ·Status: TERMINATED ·Phase: PHASE3
-
Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
NCT01653847 ·Status: COMPLETED ·Phase: NA
-
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
NCT00261820 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
NCT01780844 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
NCT01011205 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Thymoglobulin Versus Basiliximab on Regulatory T Cell Function in Live Donor Kidney Transplant Recipients
NCT02730715 ·Status: TERMINATED
-
Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant
NCT04104438 ·Status: COMPLETED ·Phase: PHASE4
-
EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function
NCT00302497 ·Status: UNKNOWN ·Phase: PHASE3
-
Standard Induction With Basiliximab Versus No-Induction in Low Immunological Risk Kidney Transplant Recipients
NCT04404127 ·Status: UNKNOWN ·Phase: PHASE4
-
Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies
NCT05385432 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients
NCT00306397 ·Status: COMPLETED ·Phase: PHASE4
-
Immune Monitoring to Facilitate Belatacept Monotherapy
NCT04177095 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Rituximab in Acute Cellular Rejection in Renal Transplant Patients
NCT01117662 ·Status: TERMINATED ·Phase: PHASE3