Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation.

Phase 4

Conditions: niertransplantatie
immunosuppressant drugs
renal transplantation
10038430

Registration Number: NL-OMON51392

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 28

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Age 2-18 years old
- Patients to be transplanted with a kidney allograft
- Patients receiving a kidney from a blood group ABO-compatible donor
- Patients who will receive tacrolimus as part of their initial
immunosuppressive therapy
- Signed written informed consent

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Recipients of a non-renal organ transplant at the same occasion
- Recipients of a blood group ABO-incompatible kidney allograft
- Recipients of an HLA-incompatible kidney allograft (positive cross-match)
- Recipients receiving tacrolimus as immunosuppressive treatment within the
preceding 28 days.
- Recipients using medication known to have a pharmacokinetic (drug-drug)
interaction with tacrolimus

Extra exclusion criteria for participation in study part B:
- Children who are not able to swallow a once-daily tacrolimus capsule
- Children with changes in the administration of drugs interacting with
tacrolimus around the switch to the once-daily formulation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of children within the target C0 range of tacrolimus (10-15<br /><br>ng/mL) on day 3 after kidney transplantation following algorithm-based dosing</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• The percentage of patients with markedly supra- (> 20 ng/L) or sub- (< 5.0<br /><br>ng/L) therapeutic tacrolimus C0 on day 3 after transplantation;<br /><br>• The percentage of patients with a tacrolimus AUC0-8 within the target range<br /><br>(140 - 180 ng h/mL) on day 9-14 after transplantation;<br /><br>• The percentage of patients with a sub- and supra-therapeutic tacrolimus<br /><br>AUC0-8 on day 9-14 post-transplantation;<br /><br>• The incidence of biopsy-proven acute rejection (BPAR) and serious adverse<br /><br>events (SAEs);<br /><br>• The incidence of viral infections (Epstein-Barr virus and Cytomegalovirus)<br /><br>and diabetes mellitus;<br /><br>• The role of the human microbiome in intra- and inter-patient variability in<br /><br>tacrolimus pharmacokinetics;<br /><br>• The description of the pharmacokinetics of a once-daily tacrolimus<br /><br>formulation.</p><br>