Pharmacokinetics of tacrolimus during pregnancy in kidney and liver transplant recipients.
Recruiting
- Conditions
- kidney transplantation and liver transplantation100196541001027310038430
- Registration Number
- NL-OMON51032
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
-Kidney or liver transplantation in medical history
-Tacrolimus based immunosuppressive regimen
-Written informed consent
Based on previous experiences with population pharmacokinetic model building,
the amount of 24 patients is sufficient to describe the pharmacokinetics during
pregnancy. Taking into consideration the already included participants before
the amendment, the drop outs and participants who are included during the
pregnancy, we estimate that around 50 patients will participate in the study.
Exclusion Criteria
• Age <18y
• Albumin concentration below 30 g/L
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The correlation between the plasma tacrolimus concentration and whole blood<br /><br>tacrolimus concentration during pregnancy in kidney and liver transplant<br /><br>recipients.</p><br>
- Secondary Outcome Measures
Name Time Method