Background: Cinacalcet could decrease serum calcium, phosphate, and parathyroid hormone (PTH) in previous meta-analyses. However, the effect of cinacalcet on the new biomarkers such as fibroblast growth factor-23 (FGF-23), bone markers, and vascular calcification are still unestablished. We conducted a meta-analysis to examine the effects of cinacalcet on all laboratory and clinical spectrums of chronic kidney disease-mineral bone disorders (CKD-MBD). Methods: A systematic literature search was conducted in MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, and Clinical Trials.gov to identify randomized controlled trials (RCTs) comparing the effect of cinacalcet relative to standard treatment on CKD-MBD surrogate markers and clinical outcomes. Random-effect models were used to compute the weighted mean difference for continuous variables and the risk ratio for binary variables. Results: Twenty-four RCTs (10,031 dialysis patients) were identified. Besides lowering effects on calcium, phosphate, and PTH, cinacalcet significantly reduced bone resorptive marker (tartrate-resistant acid phosphatase 5b) but unaltered bone formation markers (bone alkaline phosphatase and osteocalcin). Cinacalcet also resulted in significant higher risk of hypocalcemia, nausea, vomiting, and diarrhea. Cinacalcet significantly lowered serum FGF-23 level, although unaltered all-cause mortalities. Conclusions: Use of cinacalcet in dialysis patients improves several CKD-MBD-related surrogate markers. However, the benefit on all-cause mortalities was not demonstrated.

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Background: Once daily regimen could improve medical adherence and quality of life. Sirolimus based regimen can reduce calcineurin inhibitor (CNI) exposure. Therefore, we conducted randomized controlled trial, comparing once daily regimen of sirolimus and extended-release tacrolimus (ER-Tac) versus standard regimen of mycophenolic acid (MPA) and ER-Tac for late conversion in low immunologic risk kidney transplant recipients. Methods: This randomized controlled, open label, noninferiority trial was conducted from April 2018 to March 2022 at King Chulalongkorn Memorial Hospital and Bhumirajanagarindra Kidney Institute Hospital, Thailand. The kidney transplant recipients greater than 4-month posttransplant were randomized 2:1 to once daily arm and standard arm. Patients were followed up for 12 months. The primary outcome was estimated glomerular filtration rate (eGFR), CKD-EPI at 12 months. The noninferiority margin was 5 mL/min/1.73 m 2 . Donor specific antibody and protocol kidney biopsy were followed up at 12 months. Results: Seventy-two kidney transplant recipients were randomized to once daily arm (n=48) or standard arm (n=24). The baseline characteristics of patients were comparable both groups. The primary endpoint, mean eGFR at 12 months was 74.75 mL/min/1.73 m 2 in once daily group and 70.5 mL/min/1.73 m 2 in standard group (difference, 4.24; 95% confidence interval, -4.35 to 12.83). Once daily arm was noninferior as the difference does not exceed noninferiority margin. Mean change eGFR (standard error) at 12-month from baseline of once daily arm and standard arm were 1.97 (1.27) mL/min/1.73 m 2 (P=0.127) and -0.08 (1.69) mL/min/1.73 m 2 (P=0.962), respectively. De novo donor specific antibody incidence rate was 2.1% and 8.3% for once daily and standard groups, respectively. Conclusions: Once daily regimen of sirolimus and ER-Tac was noninferior to standard regimen for mean eGFR at 12-month after conversion in low immunologic risk kidney transplant recipients. Once daily regimen of sirolimus and ER-Tac could be an alternative regimen for low immunologic risk kidney transplant recipients.

Kidney TransplantationBackground. Two doses of coronavirus disease 2019 vaccination provide suboptimal immune response in transplant patients. Mycophenolic acid (MPA) is one of the most important factors that blunts the immune response. We studied the immune response to the extended primary series of 2 doses of AZD1222 and a single dose of BNT162b2 in kidney transplant patients who were on the standard immunosuppressive regimen compared to those on the MPA-sparing regimen. Methods. The kidney transplant recipients who were enrolled into the study were divided into 2 groups based on their immunosuppressive regimen. Those on the standard immunosuppressive regimen received tacrolimus (TAC), MPA, and prednisolone (standard group). The patients in the MPA-sparing group received mammalian target of rapamycin inhibitors (mTORi) with low dose TAC plus prednisolone (MPA-sparing group). The vaccination consisted of 2 doses of AZD1222 and a single dose of BNT162b2. Results. A total of 115 patients completed the study. There were 76 (66.08%) patients in the standard group and 39 (33.91%) patients in the MPA-sparing group. The overall median anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S antibody level at 4 wk after vaccine completion was 676.64 (interquartile range = 6.02-3644.03) BAU/mL with an 80% seroconversion rate. The MPA-sparing group achieved higher anti-SARS-CoV-2 S antibody level compared to the standard group (3060.69 and 113.91 BAU/mL, P < 0.001). The seroconversion rate of MPA-sparing and standard groups were 97.4% and 71.1%, respectively (P < 0.001). The anti-HLA antibodies did not significantly increase after vaccination. Conclusions. The extended primary series of 2 doses of AZD1222 and a single dose of BNT162b2 provided significant humoral immune response. The MPA-sparing regimen with mTORi and low dose TAC had a higher ant-SARS-CoV-2 S antibody level and seroconversion rate compared to the participants in the standard regimen.