HRQOL of ESRD patients differed depending on the RRT method: top values were shown by post-KTx patients, lower by PD patients, and the bottom ones by HD patients. Along with patient age, increased BP, and BMI, a drop in value of HRQOL in post-Tx or PD patients was observed. When choosing RTT method, patients may use the results of the evaluation of quality of life. A preferred lifestyle, and predominantly the work status and quality of social interaction, should decide the choice of treatment.
Summary
This multicenter, open‐label, phase III study assessed renal function, safety, and efficacy in stable adult liver transplant recipients converted from tacrolimus twice‐daily (BID) to once‐daily (QD). Patients received tacrolimus BID for 6 weeks before conversion to tacrolimus QD (1:1 [mg:mg] total daily dose basis) for 12 weeks. Primary endpoint: change in steady state creatinine clearance (CrCl) between treatment phases. Of 112 patients enrolled, 98 were converted to QD dosing (full analysis set [FAS]). Mean (SD) tacrolimus dose was 3.7 (1.7) mg/day during BID and at conversion, and 3.9 (1.8) mg/day at Week 12. 74.5% of patients required no dose adjustment on conversion (FAS). Mean tacrolimus whole blood trough levels were at the lower end of the recommended range during tacrolimus BID and QD; the difference between mean steady‐state trough levels was statistically significant (7.5 ng/ml vs. 6.5 ng/ml; P < 0.0001). Following conversion, mean tacrolimus trough levels were reduced by 15% (about 1 ng/ml) without any cases of acute rejection, remained stable during the remainder of the study, and were more consistent, showing reduced between‐ and within‐patient variability in trough levels. Renal function remained stable, demonstrating noninferiority of tacrolimus QD versus BID (relative difference in mean calculated CrCl −0.1% [±6.3%]). Patient and graft survival were 100%. Adverse events incidence was low during both treatment phases.
Development of liver transplantation program provided more than 1000 transplantations and excellent long-term results. Liver failure caused by hepatitis C and B infections remains the most common cause of liver transplantation and structure of other indications is consistent with European data.
The BNT162b2 vaccine is reportedly effective in preventing severe disease in more than 90% of the general population, but its efficacy in transplant recipients remains controversial. We aimed to determine the immune response to the BNT162b2 vaccine in kidney (KTRs) and liver transplant recipients (LTRs). In this retrospective cohort study, we included randomly 65 KTRs and 65 LTRs, who received two 30 μg doses of BNT162b2 vaccine in 3-to6-week intervals. We analyzed the anti-SARS-CoV-2 spike protein IgG antibody (anti-S1 Ab) titer, biochemical liver and renal tests, immunosuppressive drug trough level, and clinical follow up 4–6 weeks after the first dose and 4–8 weeks after the second dose. The level of protective antibodies was 57.1% in KTRs and 88.9% in LTRs after the second dose. The anti-S1 Ab response was significantly associated with sex, age, and history of COVID-19. A tacrolimus dose at vaccination but not its trough level was significantly correlated with the increase in anti-S1 Ab titer after the second vaccine dose in LTRs. Rejection episodes did not occur after vaccination. Our results showed a higher than previously reported humoral response to the BNT162b2 vaccine in KTRs and LTRs, which was dependent upon age, type of transplanted organ, and immunosuppression.
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