Evaluation of efficacy and safety of generic tacrolimus (Suprotac®) compared to reference tacrolimus (Prograf<sup>®</sup>) in kidney transplantation: a phase IV study
Background Transplant recipients are given an immunosuppressive regimen such as tacrolimus to prevent organ rejection. Suprotac® is a generic tacrolimus that is utilized in kidney transplantation regimen in Iran. This post-market study was conducted to evaluate the safety and efficacy of Suprota...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
PAGEPress Publications
2025-01-01
|
| Series: | European Journal of Translational Myology |
| Subjects: | |
| Online Access: | https://www.pagepressjournals.org/bam/article/view/13203 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832591550718148608 |
|---|---|
| author | Behzad Einollahi Mohsen Nafar Mohammad Javanbakht Amirhesam Alirezaei Jalal Azmandian Abbas Etminan Mohammad Reza Ardalan Jalal Etemadi Roghayeh Akbari Vahid Pourfarziani Seyed Sadraddin Rasi Hashemi Seyed Maryam Rahbar Shahrzad Shahidi Javid Safa Hamid Tayyebi Khosroshahi Sima Abedi Azar Shahrzad Ossareh Abdolamir Atapour Bahareh Marghoob Fatemeh Nazemian Hamidreza Kafi Araz Sabzvari |
| author_facet | Behzad Einollahi Mohsen Nafar Mohammad Javanbakht Amirhesam Alirezaei Jalal Azmandian Abbas Etminan Mohammad Reza Ardalan Jalal Etemadi Roghayeh Akbari Vahid Pourfarziani Seyed Sadraddin Rasi Hashemi Seyed Maryam Rahbar Shahrzad Shahidi Javid Safa Hamid Tayyebi Khosroshahi Sima Abedi Azar Shahrzad Ossareh Abdolamir Atapour Bahareh Marghoob Fatemeh Nazemian Hamidreza Kafi Araz Sabzvari |
| author_sort | Behzad Einollahi |
| collection | DOAJ |
| description |
Background
Transplant recipients are given an immunosuppressive regimen such as tacrolimus to prevent organ rejection. Suprotac® is a generic tacrolimus that is utilized in kidney transplantation regimen in Iran. This post-market study was conducted to evaluate the safety and efficacy of Suprotac® in comparison with Prograf®.
Methods:
In this two-armed, open-label, parallel, active-controlled, and cohort study, de novo kidney transplant recipients aging 18 to 65 years were prescribed Suprotac® or Prograf® as part of the immunosuppressant protocol. The primary outcome was comparing the mean estimated glomerular filtration rate (eGFR) at month 12. The secondary outcomes were the assessment of patient and graft survival, acute rejections during hospitalization, tacrolimus dose, trough concentration, and trough concentration/dose (C/D) ratio, and adverse events (AEs) during the study period.
Results:
A total of 201 patients were enrolled in this study. At discharge, the eGFR was lower in the Suprotac® group compared to the Prograf® group (51.70 ml/min/1.73m2 and 57.48 ml/min/1.73m2, respectively; p = 0.042). However, at month 12, there was no significant difference in mean eGFR between the two groups (58.94 ml/min/1.73m2 and 59.78 ml/min/1.73m2, respectively; p = 0.772). Other outcomes, including patient and graft survival, acute rejection during hospitalization, tacrolimus dose, trough concentration, and C/D ratio, and overall incidence of AEs were similar between the two groups (p > 0.05).
Conclusion:
The efficacy and safety profile of the generic tacrolimus were shown to be comparable to the reference tacrolimus at month 12.
|
| format | Article |
| id | doaj-art-dddd971432a149de83fe771560efb057 |
| institution | Kabale University |
| issn | 2037-7452 2037-7460 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | PAGEPress Publications |
| record_format | Article |
| series | European Journal of Translational Myology |
| spelling | doaj-art-dddd971432a149de83fe771560efb0572025-01-22T10:55:53ZengPAGEPress PublicationsEuropean Journal of Translational Myology2037-74522037-74602025-01-0110.4081/ejtm.2025.13203Evaluation of efficacy and safety of generic tacrolimus (Suprotac®) compared to reference tacrolimus (Prograf<sup>®</sup>) in kidney transplantation: a phase IV studyBehzad Einollahi0Mohsen Nafar1Mohammad Javanbakht2Amirhesam Alirezaei3Jalal Azmandian4Abbas Etminan5Mohammad Reza Ardalan6Jalal Etemadi7Roghayeh Akbari8Vahid Pourfarziani9Seyed Sadraddin Rasi Hashemi10Seyed Maryam Rahbar11Shahrzad Shahidi12Javid Safa13Hamid Tayyebi Khosroshahi14Sima Abedi Azar15Shahrzad Ossareh16Abdolamir Atapour17Bahareh Marghoob18Fatemeh Nazemian19Hamidreza Kafi20Araz Sabzvari21Nephrology and Urology Research Center, Clinical Science Institute, Baqiyatallah University of Medical Sciences, TehranChronic Kidney Disease Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, TehranNephrology and Urology Research Center, Clinical Science Institute, Baqiyatallah University of Medical Sciences, TehranDepartment of Nephrology, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, TehranPhysiology Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, KermanPhysiology Research Center, Departments of Nephrology, Urology and Renal Transplantation, Kerman University of Medical Sciences, KermanKidney Research Center, Tabriz University of Medical Sciences, TabrizKidney Research Center, Tabriz University of Medical Sciences, TabrizInfectious Diseases and Tropical Medicine Research Center, Health Research Institute, Babol University of Medical Sciences, BabolNephrology and Urology Research Center, Clinical Science Institute, Baqiyatallah University of Medical Sciences, TehranKidney Research Center, Tabriz University of Medical Sciences, TabrizDepartment of Nephrology, Sina Hospital, Tehran University of Medical Sciences, TehranIsfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, IsfahanKidney Research Center, Tabriz University of Medical Sciences, TabrizKidney Research Center, Tabriz University of Medical Sciences, TabrizKidney Research Center, Tabriz University of Medical Sciences, TabrizNephrology Section, Department of Medicine, Hasheminejad Kidney Center, School of Medicine, Iran University of Medical Sciences, TehranIsfahan Kidney Diseases Research Center, Isfahan University of Medical Sciences, IsfahanNephrology Section, Department of Medicine, Hasheminejad Kidney Center, School of Medicine, Iran University of Medical Sciences, TehranDepartment of Internal Medicine, School of Medicine, Kidney Transplantation Complications Research Center, Imam Reza Hospital, Mashhad University of Medical SciencesMedical Department, Orchid Pharmed Company, TehranCinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj Background Transplant recipients are given an immunosuppressive regimen such as tacrolimus to prevent organ rejection. Suprotac® is a generic tacrolimus that is utilized in kidney transplantation regimen in Iran. This post-market study was conducted to evaluate the safety and efficacy of Suprotac® in comparison with Prograf®. Methods: In this two-armed, open-label, parallel, active-controlled, and cohort study, de novo kidney transplant recipients aging 18 to 65 years were prescribed Suprotac® or Prograf® as part of the immunosuppressant protocol. The primary outcome was comparing the mean estimated glomerular filtration rate (eGFR) at month 12. The secondary outcomes were the assessment of patient and graft survival, acute rejections during hospitalization, tacrolimus dose, trough concentration, and trough concentration/dose (C/D) ratio, and adverse events (AEs) during the study period. Results: A total of 201 patients were enrolled in this study. At discharge, the eGFR was lower in the Suprotac® group compared to the Prograf® group (51.70 ml/min/1.73m2 and 57.48 ml/min/1.73m2, respectively; p = 0.042). However, at month 12, there was no significant difference in mean eGFR between the two groups (58.94 ml/min/1.73m2 and 59.78 ml/min/1.73m2, respectively; p = 0.772). Other outcomes, including patient and graft survival, acute rejection during hospitalization, tacrolimus dose, trough concentration, and C/D ratio, and overall incidence of AEs were similar between the two groups (p > 0.05). Conclusion: The efficacy and safety profile of the generic tacrolimus were shown to be comparable to the reference tacrolimus at month 12. https://www.pagepressjournals.org/bam/article/view/13203Tacrolimuskidney transplantationestimated glomerular filtration ratePrograf®Suprotac® |
| spellingShingle | Behzad Einollahi Mohsen Nafar Mohammad Javanbakht Amirhesam Alirezaei Jalal Azmandian Abbas Etminan Mohammad Reza Ardalan Jalal Etemadi Roghayeh Akbari Vahid Pourfarziani Seyed Sadraddin Rasi Hashemi Seyed Maryam Rahbar Shahrzad Shahidi Javid Safa Hamid Tayyebi Khosroshahi Sima Abedi Azar Shahrzad Ossareh Abdolamir Atapour Bahareh Marghoob Fatemeh Nazemian Hamidreza Kafi Araz Sabzvari Evaluation of efficacy and safety of generic tacrolimus (Suprotac®) compared to reference tacrolimus (Prograf<sup>®</sup>) in kidney transplantation: a phase IV study European Journal of Translational Myology Tacrolimus kidney transplantation estimated glomerular filtration rate Prograf® Suprotac® |
| title | Evaluation of efficacy and safety of generic tacrolimus (Suprotac®) compared to reference tacrolimus (Prograf<sup>®</sup>) in kidney transplantation: a phase IV study |
| title_full | Evaluation of efficacy and safety of generic tacrolimus (Suprotac®) compared to reference tacrolimus (Prograf<sup>®</sup>) in kidney transplantation: a phase IV study |
| title_fullStr | Evaluation of efficacy and safety of generic tacrolimus (Suprotac®) compared to reference tacrolimus (Prograf<sup>®</sup>) in kidney transplantation: a phase IV study |
| title_full_unstemmed | Evaluation of efficacy and safety of generic tacrolimus (Suprotac®) compared to reference tacrolimus (Prograf<sup>®</sup>) in kidney transplantation: a phase IV study |
| title_short | Evaluation of efficacy and safety of generic tacrolimus (Suprotac®) compared to reference tacrolimus (Prograf<sup>®</sup>) in kidney transplantation: a phase IV study |
| title_sort | evaluation of efficacy and safety of generic tacrolimus suprotac r compared to reference tacrolimus prograf sup r sup in kidney transplantation a phase iv study |
| topic | Tacrolimus kidney transplantation estimated glomerular filtration rate Prograf® Suprotac® |
| url | https://www.pagepressjournals.org/bam/article/view/13203 |
| work_keys_str_mv | AT behzadeinollahi evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT mohsennafar evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT mohammadjavanbakht evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT amirhesamalirezaei evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT jalalazmandian evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT abbasetminan evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT mohammadrezaardalan evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT jalaletemadi evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT roghayehakbari evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT vahidpourfarziani evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT seyedsadraddinrasihashemi evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT seyedmaryamrahbar evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT shahrzadshahidi evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT javidsafa evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT hamidtayyebikhosroshahi evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT simaabediazar evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT shahrzadossareh evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT abdolamiratapour evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT baharehmarghoob evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT fatemehnazemian evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT hamidrezakafi evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy AT arazsabzvari evaluationofefficacyandsafetyofgenerictacrolimussuprotaccomparedtoreferencetacrolimusprografsupsupinkidneytransplantationaphaseivstudy |