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Transplant Evidence Alert

The Transplant Evidence Alert provides a monthly overview of the 10 most important new clinical trials in organ transplantation, selected and reviewed by the Peter Morris Centre for Evidence in Transplantation (Oxford University).
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Comparative Study of 2 Extended-Release Tacrolimus Formulations in Kidney Transplantation

Transplant Proc. 2022 Nov;54(9):2434-2438 doi: 10.1016/j.transproceed.2022.10.001.

During the 1900s, tacrolimus became the mainstay immunosuppressive agent to prevent rejection after kidney transplant. Subsequently, an extended-release tacrolimus (ER-Tac) formulation was developed to improve adherence, and its generic version has been marketed over the last years. This study examines the differences in efficacy and safety between the generic ER-Tac (Conferoport) and the reference brand-name drug (Advagraf).


Prospective, randomized and parallel single-center study (May 2020 to June 2021) with 52 kidney transplant recipients who were randomly assigned to 1 of the following groups: study group (Conferoport, n = 31) and control group (Advagraf, n = 21). The variables of interest were collected and analyzed to compare tacrolimus efficacy and safety between them. Demographic characteristics of the patients and clinical donor data were homogeneous in both groups (P > .05).


No statistically significant differences were found among treatments regarding dosage used, levels, creatinine, and proteinuria (P > .05), with these variables presenting a downward trend during follow-up and, consequently, the improvement of graft function. Analyses also revealed the absence of differences concerning the incidence of acute rejection and intrapatient variability (coefficient of variation) throughout the first year of evolution between both formulations (P > .05). A total of 5 graft losses occurred, 2 resulting from patient death.


In our experience, we found no significant differences between the measured parameters in relation to the efficacy and safety profile of both drugs, with generic ER-Tac being an alternative comparable with the reference brand-name ER-Tac.

CET Conclusion
Reviewer: Mr John Fallon, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
Conclusion: This study was a prospective, randomised parallel single-centre study comparing Advagraft, a brand-name formulation of ER-Tac with a newer generic formulation, Conferoport. The study aimed to assess the safety and efficacy of the two formulations over a 12-month follow-up period after transplantation. Within this small unblinded cohort the authors found no significant difference between the groups in the doses prescribed, the blood tacrolimus levels, blood creatinine levels or proteinuria. In both groups, there was a downward trend over time in the tacrolimus dose and blood level, along with a downward trend in creatinine and proteinuria over the 12 months. There were 4 cases of biopsy-proven acute rejection, 2 in Conferoport (6.5%) and 2 in Advagraft (9.5%). The study duration is limited to 12-months so no assessment of important prolonged duration side-effects such as malignancy can be assessed. While the analysis shows no difference between the formulations, suggesting equivalent safety and efficacy, the small samples size restricts the power of the study, meaning confidence in the generic formulation is currently limited. Clinical impact is limited as the level of evidence produced is not adequate to confidently alter clinical practice currently. However, the possibility of generic formulations could be of financial benefit, as a patient on Advagraf at 6mg per day equates to an annual medication cost of around £3000.
Methodological quality
Jadad score 1
Allocation concealment NO
Data analysis PER PROTOCOL
Study Details
Aims: This study aimed to compare the efficacy and safety of the generic ER-Tac (Conferoport) versus the reference ER-Tac (Advagraf) in kidney transplant recipients.
Interventions: Participants were randomised to either the Conferoport group or the Advagraf group.
Participants: 52 kidney transplant recipients.
Outcomes: The main outcomes of interest were tacrolimus dose and levels, proteinuria, creatinine, coefficient of variation, and graft rejection.
Follow Up: 12 months
Funding: No funding was received for this study
Publication type: Randomized Controlled Trial, Randomised Controlled Trial
Organ: Kidney
Language: English
Author email:
MeSH terms: Humans; Delayed-Action Preparations; Drugs, Generic; Graft Rejection; Immunosuppressive Agents; Kidney Transplantation; Prospective Studies; Tacrolimus; Delayed Action Preparations; 0 (Delayed Action Preparations); 0 (Drugs, Generic); 0 (Immunosuppressive Agents); Wm0 Haq4 Wnm (Tacrolimus)