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Avoiding tacrolimus under- and overexposure by using a new dosing algorithm for renal transplant recipients

Avoiding tacrolimus under- and overexposure by using a new dosing algorithm for renal transplant recipients - Model based tacrolimus dosing

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46562
Enrollment
60
Registered
2018-08-09
Start date
2019-03-22
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

voorkomen afstoting na niertransplantatie kidney transplantation

Interventions

All participants will receive the tacrolimus starting dose based on a dosing algorithm which bases the dose on body surface area, CYP3A4 and CYP3A5 genotype, and age, rather than the standard bodywe

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age * 18 years old * Patients receiving a kidney from a living donor (related or unrelated) * Patients receiving a kidney from a blood group AB0-compatible donor * Patients receiving a kidney form an HLA-compatible donor (non-desensitized patients) * Patients who will receive tacrolimus as part of the initial immunosuppressive therapy * Signed written informed consent

Exclusion criteria

Exclusion criteria: * Recipients of a non-renal organ transplant at the same occasion * Recipients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days. * Recipients using medication known to have a pharmacokinetic interaction with tacrolimus

Design outcomes

Primary

MeasureTime frame
The main study endpoint of the study is the proportion of patients reaching the target C0 (7.5-12.5 ng/mL) on day 3.

Secondary

MeasureTime frame
Secondary study endpoints of the study are: * The proportion of patients reaching the target C0 (7.5-12.5 ng/mL) on day 5, 7 and 10. * The proportion of patients with markedly supra- (>20 ng/mL) or sub-therapeutic (

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)