Clinical and Safety Outcomes of Conversion Original Tacrolimus to Generic Tacrolimus in Turkish Kidney Transplant Recipients

2020 ◽  
Author(s):  
Emrah Gunay
Keyword(s):  
Serum Creatinine ◽  
The United States ◽  
Tacrolimus Concentration ◽  
Final Visit ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Dose Ratio ◽  
Primary Endpoints ◽  
Tacrolimus Level

Abstract Background After the United States, The Food and Drug Administration approved the use of the first generic of the original tacrolimus in 2009, generic tacrolimus was preferred in many countries for cost-reducing reasons. This is the first study on the conversion of original tacrolimus to the generic tacrolimus, reported from Turkey. Methods The inclusion criteria of this single-center, retrospective study were 1) being ≥18 years old, 2) passing at least three months after kidney transplantation, 3) conversion from reference tacrolimus (Prograf®) to generic tacrolimus (Adoport®). The primary endpoints were acute rejection, an increase in serum creatinine, decreases in e-GFR, tacrolimus level, tacrolimus concentration/dose ratio. We applied the paired T-test to analyze the pre-conversion and final visit laboratory values. Results Thirty-six patients who agreed to use generic tacrolimus evaluated. The mean age was 39.8 years (± 11.6), % 52,7 were female, % 86,1 were living donor transplants. The patients followed up for 12 months (3-41). There was no increase in serum creatinine value, no decreases in e-GFR and tacrolimus concentration/dose ratio. We observed a decrease in tacrolimus level (p=0,037). Decreasing the target value may have caused this result, as there are 9 patients with positive BK-DNA. None of the patients needed a biopsy. Conclusion Based on the results of our study, renal outcomes are safe and the drugs could be changed safely. Whether Prograf® or Adoport®, whichever is used, it is important to continue taking the drug at the recommended dose and time. The physician should be careful in dose adjustment after conversion, especially for those who are in the first year of transplantation.

The Epidemiologic Burden of Tacrolimus Variability among Kidney Transplant Recipients in the United States

2019 ◽  
Vol 50 (5) ◽  
pp. 370-374 ◽  
Author(s):  
Pratik B. Shah ◽  
Jennifer L. Ennis ◽  
Patrick N. Cunningham ◽  
Michelle A. Josephson ◽  
Rita L. McGill
Keyword(s):  
United States ◽  
Linear Regression ◽  
Kidney Transplant ◽  
De Novo ◽  
The United States ◽  
National Sample ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Data Set ◽  
Tacrolimus Level

Background: Within-patient tacrolimus level variability >30% has been shown to be a risk factor for de novo donor-specific antibody formation and death-censored graft failure among kidney transplant recipients. The burden of tacrolimus variability and the correlation between variability and subtherapeutic tacrolimus levels were examined in a large national data set. Methods: All tacrolimus levels drawn at LabCorp® facilities in the United States with a diagnosis code for kidney transplant between November 2011 and September 2017 were examined, excluding values that could represent new allografts. Tacrolimus variability was calculated if at least 3 levels were available. The percentage of subtherapeutic (<4.0 ng/dL) tacrolimus levels (%subT) was also calculated. Interdependence between %subT and tacrolimus variability was assessed with correlation analysis and linear regression. Results: There were 410,257 tacrolimus levels among 27,375 patients, who had 11 (interquartile range [IQR] 6–20) tacrolimus levels over a median follow-up of 26.5 (IQR 12.8–46.1) months. Median tacrolimus variability was 30.6%, and 51.6% of patients exceeded 30% variability. Median %subT was 11.1% (IQR 0–30.8%), and 34.3% of patients had no subtherapeutic levels. The correlation coefficient between tacrolimus variability and %subT was 0.253 (p< 0.001). In linear regression, tacrolimus variability increased 1.86% for each 10% increase in %subT (p < 0.001), but R-squared for this model was only 0.06. Conclusion: More than half of established kidney transplant patients from a large national sample exhibited levels of tacrolimus variability that have been associated with inferior transplant outcomes. Tacrolimus variability has a weak association with subtherapeutic levels, but represents a more complicated constellation of clinical factors.

scholarly journals BK Polyomavirus Micro-RNAs: Time Course and Clinical Relevance in Kidney Transplant Recipients

Viruses ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 351
Author(s):  
Baptiste Demey ◽  
Véronique Descamps ◽  
Claire Presne ◽  
Francois Helle ◽  
Catherine Francois ◽  
...  
Keyword(s):  
Viral Replication ◽  
Kidney Transplant ◽  
Clinical Relevance ◽  
Graft Loss ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Post Transplantation ◽  
Bk Polyomavirus ◽  
Micro Rnas

Background: Kidney transplant recipients (KTRs) are exposed to a high risk of BK polyomavirus (BKPyV) replication, which in turn may lead to graft loss. Although the microRNAs (miRNAs) bkv-miR-B1-3p and bkv-miR-B1-5p are produced during the viral cycle, their putative value as markers of viral replication has yet to be established. In KTRs, the clinical relevance of the changes over time in BKPyV miRNA levels has not been determined. Methods: In a retrospective study, we analyzed 186 urine samples and 120 plasma samples collected from 67 KTRs during the first year post-transplantation. Using a reproducible, standardized, quantitative RT-PCR assay, we measured the levels of bkv-miR-B1-3p and bkv-miR-B1-5p (relative to the BKPyV DNA load). Results: Detection of the two miRNAs had low diagnostic value for identifying patients with DNAemia or for predicting DNAuria during follow-up. Seven of the 14 KTRs with a sustained BKPyV infection within the first year post-transplantation showed a progressive reduction in the DNA load and then a rapid disappearance of the miRNAs. DNA and miRNA loads were stable in the other seven KTRs. Conclusions: After the DNA-based diagnosis of BKPyV infection in KTRs, bkv-miR-B1-3p and bkv-miR-B1-5p levels in the urine might be valuable markers for viral replication monitoring and thus might help physicians to avoid an excessive reduction in the immunosuppressive regimen.

scholarly journals Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aziza Ajlan ◽  
Hassan Aleid ◽  
Tariq Zulfiquar Ali ◽  
Hala Joharji ◽  
Khalid Almeshari ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
De Novo ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Double Blind ◽  
Donor Specific Antibodies

Abstract Background Induction therapy with IL-2 receptor antagonist (IL2-RA) is recommended as a first-line agent in low immunological risk kidney transplant recipients. However, the role of IL2-RA in the setting of tacrolimus-based immunosuppression has not been fully investigated. Aims To compare different induction therapeutic strategies with 2 doses of basiliximab vs. no induction in low immunologic risk kidney transplant recipients as per KFSHRC protocol. Methods Prospective, randomized, double blind, non-inferiority, controlled clinical trial Expected outcomes 1. Primary outcomes: Biopsy-proven acute rejection within first year following transplant 2. Secondary outcomes: a. Patient and graft survival at 1 year b. eGFR at 6 months and at 12 months c. Emergence of de novo donor-specific antibodies (DSAs) Trial registration The study has been prospectively registered at clinicaltrials.gov (NTC: 04404127). Registered on 27 May 2020.

Donor-specific hypo-responsiveness occurs in simultaneous liver-kidney transplant recipients after the first year

2018 ◽  
Vol 93 (6) ◽  
pp. 1465-1474 ◽  
Author(s):  
Timucin Taner ◽  
Michael P. Gustafson ◽  
Michael J. Hansen ◽  
Walter D. Park ◽  
Svetlana Bornschlegl ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
First Year ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients

Acute Rejection in the First Year in Heart Transplant Recipients in the United States.

2014 ◽  
Vol 98 ◽  
pp. 423
Author(s):  
A. Yoosabai ◽  
A. Mehrnia ◽  
W. Chaiwatcharayut ◽  
M. Sampaio ◽  
E. Huang ◽  
...  
Keyword(s):  
United States ◽  
Acute Rejection ◽  
Heart Transplant ◽  
The United States ◽  
First Year ◽  
Transplant Recipients ◽  
Heart Transplant Recipients

scholarly journals Relationship of Serum Bicarbonate Levels with 1-Year Graft Function in Kidney Transplant Recipients in Switzerland

2019 ◽  
Vol 44 (5) ◽  
pp. 1179-1188 ◽  
Author(s):  
Anna Wiegand ◽  
Nicole Graf ◽  
Marco Bonani ◽  
Diana Frey ◽  
Rudolf P. Wüthrich ◽  
...  
Keyword(s):  
Kidney Transplant ◽  
Graft Function ◽  
First Year ◽  
Kidney Graft ◽  
Serum Bicarbonate ◽  
Transplant Recipients ◽  
Kidney Transplant Recipients ◽  
Open Label ◽  
Post Hoc ◽  
Relationship Of

Background: Metabolic acidosis (MA) is common in kidney transplant recipients (KTRs). Several studies have shown that MA is involved in the progression of chronic kidney disease. However, it is unclear if there is also a relationship between serum bicarbonate and graft function after kidney transplantation (KTx). We hypothesized that low serum bicarbonate is associated with a lower estimated glomerular filtration rate (eGFR) 1 year after KTx. Methods: We performed a post hoc analysis of a single-center, open-label randomized trial in 90 KTRs and investigated the relationship of serum bicarbonate and graft function in the first year after KTx. Results: Prevalence of MA was high after KTx (63%) and decreased to 28% after 1 year. Bicarbonate (20.6 ± 3.0 to 22.7 ± 2.7 mmol/L) increased in the first year after transplantation whereas eGFR (53.4 ± 15.8 to 56.9 ± 18.5 mL/min/1.73 m2) did not change significantly. Higher serum bicarbonate (p = 0.029) was associated with higher eGFR in the first year after KTx. Conclusion: Prevalence of MA is high in KTRs. In the first year after KTx, serum bicarbonate was positively correlated with eGFR, suggesting a potential role of MA in kidney graft function.

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