Skip to content

The pharmacokinetic/toxicity study of mycophenolic acid in the Chinese heart transplant patitents

The pharmacokinetic/toxicity study of mycophenolic acid in the Chinese heart transplant patitents

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000030903
Enrollment
Unknown
Registered
2020-03-16
Start date
2020-03-16
Completion date
Unknown
Last updated
2020-03-23

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

Conditions

Heart Transplantation

Interventions

Intensive sampling arm:Ten peripheral venous blood were collected before taking MPA at steady state and 0.5 ~ 12 h after taking the medicine, and the gene polymorphism was detected.
Sparse sampling arm:Collect 5 to 6 MPA plasma concentrations each time
The above blood collection points may be adjusted according&
Validation arm:Fifteen patients for external validation were enrolled. MPA samples were collected according to the optimally designed with the minimum number of samples, and individual PK parameters w

Sponsors

Guangdong General Hospital (Guandong Academy of Medical Sciences)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Heart transplant recipients who is taking mycophenolate mofetil; 2. Co-medication wtih tacrolimus or cyclosporin; 3. Male of female, aged 18-75 years; 4. Multiple sample collection is acceptable for the patients; 5. Good treartment compliance and integrate medical records.

Exclusion criteria

Exclusion criteria: 1. Mycophenolate mofetil immediate release tablets are changed to the enteric coated formulations for severe gastrointestinal reactions; 2. Patients who are allergic to mycophenolate mofetil or mycophenolic acid (MPA); 3. Bad treatment compliance; 4. The research physician did not consider it appropriate for the enrollment.

Design outcomes

Primary

MeasureTime frame
Plasma concentration of mycophenolic acid;

Secondary

MeasureTime frame
Genotypes;

Countries

China

Contacts

Public ContactMin Wu

Guangdong Cardiovascluar Institute

26396284@qq.com+86 18925046785

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026