ISSN: 2375-3900
American Journal of Pharmacy and Pharmacology  
Manuscript Information
 
 
The Association Between the Serum Levels of Generic Tacrolimus (Framebin) in Acute Renal Graft Dysfunction
American Journal of Pharmacy and Pharmacology
Vol.5 , No. 3, Publication Date: Aug. 2, 2018, Page: 19-26
485 Views Since August 2, 2018, 319 Downloads Since Aug. 2, 2018
 
 
Authors
 
[1]    

Delgado-Lara Daniela Lucero del Carmen, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.

[2]    

Cerrillos-Gutiérrez José Ignacio, Department of Nephrology and Transplants, IMSS, Guadalajara, Mexico.

[3]    

Hernández-Sánchez Gerardo, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.

[4]    

Rodríguez-Razón Christian, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.

[5]    

Rojas-Campos Enrique, Kidney Diseases Medical Research Unit, IMSS, Guadalajara, Mexico.

[6]    

Miranda-Díaz Alejandra Guillermina, Institute of Experimental and Clinical Therapeutics, University of Guadalajara, Guadalajara, Mexico.

 
Abstract
 

Background. There is always the possibility of acute renal graft dysfunction (AGD) after renal transplantation (RT). AGD is suspected because of a decrease in urine volume, an increase in baseline serum creatinine (SCr) or proteinuria. Tacrolimus (TAC) is a calcineurin inhibitor (CI) with immunosuppressive function. Aim. To analyze the association between serum levels of generic TAC (Framebín) with the presence of renal AGD. Material and methods. An analytical cross-sectional study included 41 patients with AGD and 41 without AGD (N-AGD) who were managed with a generic TAC. The post-transplant follow-up was <1 year. TAC levels were determined by EMIT 2000, 12 h after ingestion of the medication. The AGD or N-AGD was confirmed by percutaneous renal biopsy. Results. The serum levels of TAC were found increased in all patients. The TAC levels in the AGD was 16.5±11.8 ng/mL vs. N-AGD, 11.6±7.7 ng/mL (p=0.029). When adjusting the TAC levels according to the post-transplant month, no significant difference was found between the two groups (p=0.265). There was a low positive correlation between TAC levels and the SCr levels on the day of measurement (r=0.24, p=0.027). The logistic regression analysis associated the AGD with higher body weight of the patients (OR=1043, 95% CI 1.000-1.088, p=0.050). Having more months after transplant was a protective factor for not presenting AGD (OR=0.763, 95% CI 0.647-0.900, p=0.001). TAC levels were not associated with AGD. In patients with AGD, renal biopsy reported 34% acute rejection (AR) and 64% CI toxicity. The histological result of N-AGD patients reported; 76%, normal biopsy, 12% AR and 12% CI toxicity. Conclusions. Serum TAC levels were found to be increased in all patients without correlation with renal biopsy. Determining TAC levels was not a good marker to detect AGD. The increase in body weight seems to increase the possibility of presenting AGD.


Keywords
 

Kidney Transplantation, Generic Tacrolimus, Acute Graft Dysfunction, Renal Rejection, Calcineurin Inhibitor Poisoning


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