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Immunosuppressive drug bioequivalence in kidney transplant recipients – Prograf and CellCept
EU CTIS ID: 2025-521800-22-00
What this study is testing
Assess oral bioequivalence of generic Tac and MMF in kidney transplant recipients at steady-state.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Kidney transplant recipients on stable immunosuppressive therapy for the last two weeks
- • Immunosuppressive drug regimen containing Prograf® (tacrolimus twice daily), CellCept® (mycophenolate mofetil twice daily).
- • Above 18 years of age.
- • Able to comply with the medical treatment on their own.
- • Signed informed consent.
You likely can't join if
- • Recent (1 month) rejection episode of the kidney graft treated with methylprednisolone.
- • Ongoing acute infectious disease, including any eventual treatment for the infection, that may influence drug PK.
- • Concomitant treatment with interacting drugs such as (but not limited to): cyclosporine, oral calcium supplements, diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, ritonavir, cholestyramine, rifampicin, ciprofloxacin, vancomycin, amoxicillin/clavulanic acid, cholestyramine, rifampicin, ciprofloxacin, vancomycin, amoxicillin/clavulanic acid.
- • Concomitant anti-coagulation treatment that affects capillary finger-prick sampling.
- • Severe diarrhea.
- • Women who are breastfeeding, pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (see section 6.7 for details).
See the full eligibility criteria
- • Kidney transplant recipients on stable immunosuppressive therapy for the last two weeks
- • Immunosuppressive drug regimen containing Prograf® (tacrolimus twice daily), CellCept® (mycophenolate mofetil twice daily).
- • Above 18 years of age.
- • Able to comply with the medical treatment on their own.
- • Signed informed consent.
- • Recent (1 month) rejection episode of the kidney graft treated with methylprednisolone.
- • Ongoing acute infectious disease, including any eventual treatment for the infection, that may influence drug PK.
- • Concomitant treatment with interacting drugs such as (but not limited to): cyclosporine, oral calcium supplements, diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, ritonavir, cholestyramine, rifampicin, ciprofloxacin, vancomycin, amoxicillin/clavulanic acid, cholestyramine, rifampicin, ciprofloxacin, vancomycin, amoxicillin/clavulanic acid.
- • Concomitant anti-coagulation treatment that affects capillary finger-prick sampling.
- • Severe diarrhea.
- • Women who are breastfeeding, pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (see section 6.7 for details).
- • Severe medical condition that may affect drug metabolism, transportation and therefore study outcomes.
- • Hypersensitivity to the active substances or any of the excipients of the study drugs.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.