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Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients

Año 2021
Registro de estudios clinicaltrials.gov
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To explore the efficacy of treatment of pulmonary cytokine storm induced by SARS-CoV2 with a monoclonal antibody to IL-2 (Basiliximab) in addition to current standard of care vs current standard of care with the primary efficacy endpoint being the proportion of subjects alive and free of ventilator support, defined as intubation and requiring mechanical ventilation, at Day 28 from time of randomization.

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Basiliximab Induction and Postoperative Steroid-free Immunosuppression with Tacrolimus in Pediatric Liver Transplantation: A Randomized Clinical Trial

Año 2024
Autores Dong C , Song Z , Sun C , Wang K , Zhang W , Chen J - Más
Revista Transplantation
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Background. Optimizing the immunosuppressive regimen is essential to improve the long-term outcomes of pediatric liver transplant recipients. Methods. We conducted a prospective, randomized, open-label study to compare the safety and efficacy of 2 treatment approaches during pediatric liver transplantation: tacrolimus monotherapy following basiliximab induction (the study group) and a dual regimen of tacrolimus plus steroids (the control group). A total of 150 patients were enrolled, with 75 patients allocated to each group. Results. In both groups, recipients achieved graft and recipient overall survival rates exceeding 93%, with no statistically significant differences between them. However, the study group exhibited a significantly lower incidence of acute cellular rejection (ACR), delayed occurrence of ACR, and an improved ACR-free survival rate at 2 y compared with the control group. Notably, the study group also showed a significant reduction in the incidence of de novo donor-specific antibodies at 3-mo and 2-y posttransplant. Furthermore, 6 mo after the transplant, the study group demonstrated significant improvements in weight-for-age Z score and height-for-age Z score. No notable differences were observed in postoperative complications or the incidence of liver fibrosis between the 2 groups. Conclusions. Basiliximab induction combine with tacrolimus (TAC) monotherapy is a safe and effective immunosuppressive regimen to reduce the episodes of ACR without influencing the development of liver fibrosis and graft and recipient survival rate after pediatric liver transplantation.

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Randomized trial of steroid free immunosuppression with basiliximab induction in adult live donor liver transplantation (LDLT).

Año 2021
Revista HPB : the official journal of the International Hepato Pancreato Biliary Association
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BACKGROUND:

Corticosteroids are an integral part of immunosuppression following solid organ transplantation, despite their metabolic complications. We conducted a randomized trial to evaluate the efficacy of steroid-free immunosuppression following live donor liver transplantation (LDLT).

METHODS:

We randomized 104 patients stratified based on pre-transplant diabetic status to either a steroid-free arm (SF-arm) (Basiliximab + Tacrolimus and Azathioprine,n = 52) or Steroid arm (S-Arm) (Steroid + Tacrolimus + Azathioprine,n = 52). The primary endpoint was the occurrence of metabolic complications (new-onset diabetes after transplant (NODAT), new-onset systemic hypertension after transplant (NOSHT), post-transplant dyslipidemia) within 6 months after transplant. Secondary endpoints included biopsy-proven acute rejection (BPAR) within six months, patient and graft survival at 6 months.

RESULTS:

The incidence NODAT was significantly higher in S-arm at 3 months (64.5%vs. 28.1%,p-0.004) and 6 months (51.6% vs. 15.6%,p-0.006). Likewise, the incidence of NOSHT (27.8% vs. 4.8%,p-0.01) and hypertriglyceridemia (26.7% vs. 8%,p-0.03) at six months was significantly higher in S-arm. However, there were no differences in BPAR (19.2% vs. 21.2%, p-0.81), time to first rejection (58 vs. 53 days, p-0.78), patient and graft survival (610 vs. 554 days,p- 0.22).

CONCLUSION:

Following LDLT, basiliximab induction with tacrolimus and azathioprine maintenance resulted in significantly lower metabolic complications compared to the triple-drug regimen of steroid, tacrolimus, and azathioprine.

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The Effect of Monthly Anti-CD25+ Treatment with Basiliximab on the Progression of Chronic Renal Dysfunction after Lung Transplantation.

Año 2020
Autores Ross DJ , Belperio J , Natori C , Ardehali A
Revista International journal of organ transplantation medicine
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BACKGROUND:

Chronic renal dysfunction (CRD), as predominantly related to calcineurin-inhibitor (CNI) nephrotoxicity, is associated with increased morbidity and mortality after lung transplantation (LTx). Basiliximab (BSX), a recombinant chimeric monoclonal antibody against CD25+ on activated T-lymphocytes, although often employed as an "induction immunosuppression" after solid organ transplantation, may further allow for reduction in CNI exposure with monthly administration and amelioration of CRD.

OBJECTIVE:

To determine the effect of monthly anti-CD25+ treatment with basiliximab on the progression of chronic renal dysfunction after lung transplantation.

METHODS:

Post-LTx recipients with stages IIIB-V CRD were treated with monthly intravenous infusion of BSX 20 mg. They were analyzed for creatinine clearance at 1, 3, 6, and 12 months; rate of the change in the clearance (the slope of the regression line) and FEV1/month; de novo HLA class I or II DSA; and infectious events (IE). Tacrolimus (TAC) trough levels were concurrently targeted at 2-4 ng/mL during BSX therapy. The criteria for BSX discontinuation included acute lung allograft rejection, acute respiratory infection, and progression to end-stage renal disease (ESRD).

RESULTS:

9 LTx recipients were treated with BSX for ≥6 months. The median time past after their LTx was 1853 (range: 75-7212) days; the mean±SD age was 64.3±11.3 years; the male:female ratio was 7:2. The baseline mean±SD creatinine clearance 1-3 months prior to BSX initiation was 22.8±5.14 mL/min/1.73 m2 (CI: 3.95) consistent with CRD stages-IIIB (2), IV (6), and V (1). Prior to BSX treatment, all 9 patients had established CLAD-obstructive-phenotype (BOS, n=4) and restrictive-phenotype (RAS, n=5). During the course of BSX treatment, the aggregate creatinine clearance mean slope increased by a mean±SD of 0.747±0.467 mL/min/1.72 m2/month (CI: 0.359), consistent with "stabilization" of renal function in 7 patients; deterioration occurred in 2 with transition to chronic hemodialysis. Spirometric stability in lung allograft function was observed in 5 patients with a mean±SD aggregate FEV1 slope of -1.49±1.08 mL/month (CI: 2.50). 3 deaths occurred due to the following conditions during BSX treatment-HFpEF/Sepsis + CLAD/Parainfluenza type 2 bronchiolitis + CLAD. 2 recipients developed "weak MFI" HLA class II DSA; no HLA class I DSA was detected during the treatment.

CONCLUSION:

Renal sparing therapy with monthly BSX infusion with concurrent reduction in CNI exposure (TAC = 2-4 ng/mL) for stages IIIB-V CRD was associated with stability in creatinine clearance in 78% of patients over a treatment course of 6-12 months. Pre-existing CLAD afflicting all patients and inherent variability in progression of chronic rejection, limits our assessment of BSX efficacy in this context. We detected an infrequent de novo HLA class II DSA during BSX therapy.

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Comparison of Basiliximab and Anti-Thymocyte Globulin as Induction Therapy for Simultaneous Heart-Kidney Transplantation in the Contemporary Era

Año 2024
Revista Journal of Heart and Lung Transplantation
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A randomized, double-blind, placebo-controlled trial of basiliximab with concomitant corticosteroids in steroid-refractory ulcerative colitis

Año 2009
Revista Gastroenterology
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Reduced acute rejection and superior one‐year renal allograft survival with basiliximab (Simulect) in patients with diabetes mellitus

Año 1998
Revista XVII World Congress of the Transplantation Society
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Basiliximab (Simulect) is efficacious in reducing the incidence of acute rejection episodes in renal allograft patients: results at 12 months

Año 1998
Revista Transplantation
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Basiliximab (Simulect) significantly reduces the incidence of acute rejection in renal transplant patients receiving triple therapy with azathioprine

Año 2000
Revista Transplantation
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Estudio primario

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Basiliximab (Simulect) is efficacious in reducing the incidence of acute rejection episodes in renal allograft patients: results at 12 months

Año 1998
Revista Transplantation
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