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CALCIGRAN FORTE AND DOSING OF IMMUNOSUPPRESSIVE DRUGS IN KIDNEY TRANSPLANT RECIPIENTS
EU CTIS ID: 2024-515164-30-00
What this study is testing
To investigate the effect of calcium supplement treatment on tacrolimus and mycophenolate mofetil pharmacokinetics when administered together in stable kidney transplant recipients.
- 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 5 days
- Immunosuppressive drug regimen containing Prograf® (tacrolimus twice daily), CellCept® (mycophenolate mofetil twice daily) and prednisolone.
- Above 18 years of age
- Clinical in need of calcium/vitamin D supplement, defined as a dietary calcium intake <1000 mg/day.
- Able to comply with the medical treatment on their own.
- Signed informed consent.
You likely can't join if
- Recent (1 week) rejection episode of the kidney graft treated with methylprednisolone.
- Ongoing acute infectious disease, including any eventual treatment for the infection, that may influence drug pharmacokinetics
- Concomitant treatment with interacting drugs such as (but not limited to): diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, ritonavir.
- Concomitant anti-coagulation treatment that affects capillary finger-prick sampling.
- Severe diarrhoea.
- Women who are breastfeeding, pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (not acceptable methods: progesterone-only oral hormonal contraception, male/female condom without spermicide or cap, diaphragm or sponge with spermicide
See the full eligibility criteria
- Kidney transplant recipients on stable immunosuppressive therapy for the last 5 days
- Immunosuppressive drug regimen containing Prograf® (tacrolimus twice daily), CellCept® (mycophenolate mofetil twice daily) and prednisolone.
- Above 18 years of age
- Clinical in need of calcium/vitamin D supplement, defined as a dietary calcium intake <1000 mg/day.
- Able to comply with the medical treatment on their own.
- Signed informed consent.
- Recent (1 week) rejection episode of the kidney graft treated with methylprednisolone.
- Ongoing acute infectious disease, including any eventual treatment for the infection, that may influence drug pharmacokinetics
- Concomitant treatment with interacting drugs such as (but not limited to): diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, ritonavir.
- Concomitant anti-coagulation treatment that affects capillary finger-prick sampling.
- Severe diarrhoea.
- Women who are breastfeeding, pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (not acceptable methods: progesterone-only oral hormonal contraception, male/female condom without spermicide or cap, diaphragm or sponge with spermicide
- Hypercalcemia or hypercalciuria
- Nephrolithiasis
- Hypervitaminosis D
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, 65+ years, 18-64 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.