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A SINGLE-CENTER PHARMACOGENETIC STUDY OF DONOR AND RECIPIENT TO IMPROVE THE EFFICACY AND REDUCE THE NEPHROTOXICITY OF TACROLIMUS AFTER KIDNEY TRANSPLANTATION.

A SINGLE-CENTER PHARMACOGENETIC STUDY OF DONOR AND RECIPIENT TO IMPROVE THE EFFICACY AND REDUCE THE NEPHROTOXICITY OF TACROLIMUS AFTER KIDNEY TRANSPLANTATION.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22836
Enrollment
250
Registered
2010-02-25
Start date
2010-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Kidney transplantation

Interventions

Patients in the standard tacrolimus dose group will receive a dose of 0.20 mg tacrolimus/kg bodyweight per day in two equally divided doses. Patients in the CYP3A5 dosing group will receive a tacrolim

Sponsors

Erasmus Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult recipients (18 years or older) who are to receive an ABO-compatible single-organ kidney transplant from a living donor (related or unrelated) will be eligible for entry into the study.

Exclusion criteria

Exclusion criteria: Patients receiving immunosuppressive therapy (except steroid treatment) within the preceding 28 days except for pretransplant immunosuppressive medication (up to 48 hr before transplantation) will not be included. In addition, patients using medication known to have a pharmacokinetic interaction with tacrolimus will not be asked to participate in the study.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is the proportion of patients reaching target levels (10-15 ng/ml) on day 3 and day 7 after transplantation.

Secondary

MeasureTime frame
Secondary endpoints are the incidence of biopsy-proven acute rejection (BPAR) within the first three months after transplantation and renal function at three months after transplantation.

Contacts

Public ContactT. Gelder, van

's Gravendijkwal 230

t.vangelder@erasmusmc.nl+31 (0)10 7033202

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)