A Multi Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after Transplantation

A Multi Center, Prospective, Observational, Open-label, Pharmacokinetic Study of Tacrolimus in Heart and Lung Transplantation Patients during the First Days after Transplantation - Spartacus

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39373

Enrollment

Registered

2012-04-27

Start date

2013-05-07

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Heart and lung transplantation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients * 18 years;* Patients admitted to the ICC of UMCU after heart or lung transplantation;* Treated with tacrolimus (Prograft®; Astellas Pharma Europe);* Informed consent obtained

Exclusion criteria

Exclusion criteria: * Patients < 18 years;* Patients who die within one day after admission to the ICC of UMCU;* Withdrawal of informed consent;* Allergy towards tacrolimus or macrolides;* Patients on total parenteral nutrition

Design outcomes

Primary

Measure	Time frame
The main study parameters are whole blood total tacrolimus concentrations and unbound tacrolimus plasma concentrations together with the pharmacokinetic parameters: AUC, Cmin, Cmax, Tmax, T1/2, Vd, CL, CL/F (=oral clearance).	—

Secondary

Measure	Time frame
Variables influencing unbound plasma tacrolimus concentrations: * Renal dysfunction * Erythrocytes or Hematocrit * Albumin * alpha-1-Acid glycoprotein * High density lipoprotein * pH * Daily fluid balance and body weight * CYP3A4/CYP3A5 gene expression, and P-glycoprotein gene expression * Hepatic dysfunction: bilirubin and ALAT will be used to quantify hepatic dysfunction * Diarrhoea or ileus * Cystic fibrosis * Plasma concentrations of (val)acyclovir, (val)ganciclovir, tobramycin and trimethoprim/sulfamethoxazole, if administered, will be measured at steady state as possible additional factor causing kidney dysfunction	—

Measure

Time frame

Variables influencing unbound plasma tacrolimus concentrations: * Renal dysfunction * Erythrocytes or Hematocrit * Albumin * alpha-1-Acid glycoprotein * High density lipoprotein * pH * Daily fluid balance and body weight * CYP3A4/CYP3A5 gene expression, and P-glycoprotein gene expression * Hepatic dysfunction: bilirubin and ALAT will be used to quantify hepatic dysfunction * Diarrhoea or ileus * Cystic fibrosis * Plasma concentrations of (val)acyclovir, (val)ganciclovir, tobramycin and trimethoprim/sulfamethoxazole, if administered, will be measured at steady state as possible additional factor causing kidney dysfunction

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Countries

Netherlands

Outcome results