Kidney transplantationCalcineurin antagonistsConversion of Stable Kidney Transplant Recipients From a Twice Daily Prograf-Based Regimen to a Once Daily Modified Release Tacrolimus-Based Regimen
Section snippets
Methods
This was an open-label, multicenter, PK, safety, and tolerability study. To be eligible, patients had to be between 18 and 65 years of age, more than 6 months post–kidney transplant taking stable Prograf doses twice a day for at least 2 weeks prior to study enrollment, and they had to have stable renal function (serum creatinine less than 3.0 mg/dL and variation less than 0.5 mg/dL for 2 levels drawn at least 6 days apart). Patients were excluded if they were receiving any drugs known to
Results
Seventy patients were enrolled in the study; 67 patients (95.7%) completed all 5 PK profiles; and 66 patients (94.2%) completed all 5 PK profiles without a dosing conversion error and were considered for PK evaluation. Among these patients, there were 42 men (63.6%), 24 women (36.4%), 53 Caucasian (80.3%), 12 African Americans (18.2%), and 1 Asian (1.5%). The mean age was 46.9 ± 12.37 years.
The mean total daily dose of Prograf at baseline upon enrollment was 5.7 ± 3.47 mg. Approximately 70% of
Summary
The steady state tacrolimus PK of MR tacrolimus is equivalent to Prograf after a milligram-for-milligram daily dose conversion in stable kidney transplant recipients regardless of gender, race, or presence of diabetes. Also, the high correlation of exposure to trough levels for both Prograf and MR tacrolimus indicates that the therapeutic monitoring system currently used for Prograf can be effectively employed for patients receiving MR tacrolimus once daily. There is significantly less
References (6)
- et al.
New drugs to improve transplant outcomes
Transplantation
(2004) - et al.
Patient noncompliance: a major cause of late graft failure in cyclosporine-treated renal transplants
Transplant Proc
(1998) - et al.
Frequency and impact of nonadherence to immunosuppressants after transplantation: a systematic review
Transplantation
(2004)
Cited by (123)
Once daily tacrolimus conversion in lung transplantation: A prospective study on safety and medication adherence
2021, Journal of Heart and Lung TransplantationCitation Excerpt :Bioequivalence ranged between 80% and 125%.21 The same observations were also observed in stable kidney22 and liver transplant recipients.23 In our study of stable LTx recipients, we demonstrated that a 1 mg:1 mg tacrolimus conversion resulted in a slight but significant decrease in Cmin, requiring subsequent up-titration of the daily dose to maintain a similar level of pharmacological immunosuppression.
Renal Function and Patient-Reported Outcomes in Stable Kidney Transplant Patients Following Conversion From Twice-Daily Immediate-Release Tacrolimus to Once-Daily Prolonged-Release Tacrolimus: A 12-Month Observational Study in Routine Clinical Practice in Germany (ADAGIO)
2021, Transplantation ProceedingsConversion From a Twice-Daily to a Once-Daily Tacrolimus Formulation in Kidney Transplant Recipients
2020, Transplantation ProceedingsResults of ASERTAA, a Randomized Prospective Crossover Pharmacogenetic Study of Immediate-Release Versus Extended-Release Tacrolimus in African American Kidney Transplant Recipients
2018, American Journal of Kidney DiseasesCitation Excerpt :Modified-release drugs are commonly developed to attenuate fluctuation and reduce dosing administration frequency.39 The 2 available once-daily tacrolimus formulations, LCPT and extended release tacrolimus (ER-Tac; Astagraf XL; Astellas Pharma US, Inc) are not bioequivalent to one another40 or to IR-Tac.41-45 Although conversion from IR-Tac to ER-Tac frequently necessitates a dose escalation to achieve similar trough concentrations and AUC0-24,13,46 conversion of ER-Tac or IR-Tac to LCPT has been demonstrated to require dose reductions of about 36% and 20%, respectively.40
This study was supported by Fujisawa Healthcare, Inc. and was also presented in part at the American Transplant Congress (ATC) Annual Meeting in Boston, Massachusetts on May 16, 2004.