Background: The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy. Methods: In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1–2 months (M) apart 4–18M posttransplant. Anti–glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post–dose 1, and 1M and 12M post–dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post–dose 2. Results: Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post–dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups. Conclusions: RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose. Clinical Trials Registration: NCT02058589.

The use of non–heart-beating donors could help shorten the list of patients who are waiting for a kidney transplant. Several reports describe acceptable results of transplantations from non–heart-beating donors who had in-hospital cardiac arrest, but few reports describe results of transplantations from non–heart-beating donors who had cardiac arrest that occurred outside of the hospital (Maastricht type I and type II donors). To compare graft survival rates among patients receiving kidneys from heart-beating donors versus type I or type II non–heart-beating donors. Retrospective cohort study of transplantations performed from January 1989 to December 2004. Kidney transplant program of a teaching hospital in Madrid, Spain. 320 patients who received a kidney transplant from non–heart-beating donors (273 type I donors and 47 type II donors) and 584 patients who received a kidney transplant from heart-beating donors divided into 2 groups according to donor age (age <60 years [n = 458] and age ≥60 years [n = 126]). The primary outcome measure was graft survival. The median follow-up time was 68 months (range, 9 to 198 months). One- and 5-year graft survival rates were 90.7% and 85.5%, respectively, for transplants from heart-beating donors younger than 60 years of age; 79.8% and 73.3%, respectively, for transplants from heart-beating donors 60 years of age or older (P < 0.001); and 87.4% and 82.1%, respectively, for transplants from non–heart-beating donors (P = 0.22 [vs. those from heart-beating donors < 60 years of age] and P = 0.014 [vs. those from heart-beating donors ≥ 60 years of age]). Graft survival did not differ between patients who received kidneys from heart-beating donors younger than 60 years of age and patients who received kidneys from non–heart-beating donors. This single-site, observational study was retrospective, and immunosuppressive therapy regimens given to transplant recipients varied over time. Outcomes of transplants from non–heart-beating donors and younger heart-beating donors are similar, and results for transplants from non–heart-beating donors improved compared with those from older heart-beating donors. On the basis of these results, the authors encourage other transplant units to adopt the use of type I and type II non–heart-beating donors.

Background: Sodium–glucose cotransporter-2 inhibitors (SGLT2is) have cardioprotective and renoprotective effects. However, experience with SGLT2is in diabetic kidney transplant recipients (DKTRs) is limited.Methods: This observational multicentre study was designed to examine the efficacy and safety of SGLT2is in DKTRs. The primary outcome was adverse effects within 6 months of SGLT2i treatment.Results: Among 339 treated DKTRs, adverse effects were recorded in 26%, the most frequent (14%) being urinary tract infection (UTI). In 10%, SGLT2is were suspended mostly because of UTI. Risk factors for developing a UTI were a prior episode of UTI in the 6 months leading up to SGLT2i use {odds ratio [OR] 7.90 [confidence interval (CI) 3.63–17.21]} and female sex [OR 2.46 (CI 1.19–5.03)]. In a post hoc subgroup analysis, the incidence of UTI emerged as similar in DKTRs treated with SGLT2i for 12 months versus non-DKTRs (17.9% versus 16.7%). Between baseline and 6 months, significant reductions were observed in body weight [−2.22 kg (95% CI −2.79 to −1.65)], blood pressure, fasting glycaemia, haemoglobin A1c [−0.36% (95% CI −0.51 to −0.21)], serum uric acid [−0.44 mg/dl (95% CI −0.60 to −0.28)] and urinary protein:creatinine ratio, while serum magnesium [+0.15 mg/dl (95% CI 0.11–0.18)] and haemoglobin levels rose [+0.44 g/dl (95% CI 0.28–0.58]. These outcomes persisted in participants followed over 12 months of treatment.Conclusions: SGLT2is in kidney transplant offer benefits in terms of controlling glycaemia, weight, blood pressure, anaemia, proteinuria and serum uric acid and magnesium. UTI was the most frequent adverse effect. According to our findings, these agents should be prescribed with caution in female DKTRs and those with a history of UTI.

Background. Due to possible complications and treatment limitations, the prevention of influenza in renal transplant (RT) patients is highly indicated. Methods. Forty-nine patients with a 1-year functioning RT subjected to two different immunosuppressive regimens and 37 healthy relatives (HR) were administered the anti-influenza vaccine as recommended for 1996 to 1997. Anti-influenza antibody, creatinine, and immunological markers were estimated at 1 and 3 months after vaccination. Results. Three months after vaccination, 46.2% of the RT patients and 69% of the HR (P =0.06) showed protective antibody titers to influenza A (relative risk [RR]; 0.67; 95% confidence interval: 0.44–1.02). A total of 20.5% of the RT patients and 44.8% of the HR showed antibodies to influenza B (P =0.03). Despite these differences, the incidence of illness was similar. The immunosuppressive regimen had no effect on the antibody response. Conclusions. Although the RT patients showed a reduced antibody response, no negative effects on graft outcome were observed.

Prolonged‐release tacrolimus was developed to provide a more convenient once‐daily dosing that could improve patient adherence. We conducted a multicenter, prospective, observational, 12‐month study to describe the efficacy, safety and patient preference of conversion from tacrolimus twice‐daily to once‐daily formulation in stable kidney transplant recipients in routine clinical practice. Conversion was made on a 1 mg: 1 mg basis (1 mg: 1.1 mg in patients with trough levels <6 ng/mL). The study included 1832 patients (mean age (±SD): 50.0 ± 13.4 years; 62.7% male). After conversion, a modest reduction in tacrolimus trough levels, necessitating an increase in daily dose, was observed (mean changes at 12 months of –9.1% and +1.24%, respectively; p < 0.0001). Mean glomerular filtration rate did not change significantly (56.5 ± 19.7 mL/min at conversion vs. 55.7 ± 20.6 mL/min at 12 months). Proteinuria, blood pressure, lipid, hepatic and glucose parameters remained stable. Eight patients (0.4%) had acute rejection and 34 patients (1.85%) discontinued treatment. Almost all patients (99.4%) preferred the once‐daily formulation, because of less frequent dosing (66%) and improved adherence (34%). In conclusion, at similar doses to twice‐daily tacrolimus, once‐daily formulation provided stable renal function, a low acute rejection rate, and good tolerability in stable kidney transplant recipients in the routine clinical practice setting.