An observational study of i)mini-area-under-the-curve (mini-AUC) estimation of exposure to mycophenolic acid (MPA) in heart transplant and lung transplant recipients on mycophenolate mofetil (MMF)or Mycophenolate Sodium (Myfortic) ii) utility of salivary measurements of MPA levels in heart & lung transplant recipients. - Simultaneous estimation of Myclophenolic Acid in saliva and blood in heart and lung transplant patie

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-002201-53-GB

Enrollment

Registered

2007-06-26

Start date

2007-08-30

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Immunosuppression after heart and lung transplantation MedDRA version: 9.1 Level: LLT Classification code 10056409 Term: Heart and lung transplant

Interventions

Trade Name: Myfortic Product Name: Myfortic Pharmaceutical Form: Film-coated tablet Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who meet the standard hospital guidelines for having a heart and/or lung transplant. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Those patients who are unwilling or unable to provide informed consent. Females of childbearing potential who are planning to become pregnant, who are pregnant who are unwilling to use effective means of contraception.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Also correlating MPA levels with side effects such as nausea/vomiting/diarrhoea (all patients will receive a questionnaire for GI side effects at weekly intervals for first month and monthly thereafter). ; Main Objective: An observational study of MPA levels in peripheral blood and saliva of Heart Transplant and Lung Transplant patients (average of 35 transplants/yr) • Mini-area under the curve (AUC) [AUC 3 point approximation using 0, 30 and 120 minutes after morning intake] as per recent study by Doesch et al (Protocol ref 4). This study would be observational in terms of watching clinical course (rejection, infection including both bacterial, viral & fungal episodes) ; Primary end point(s): We will measure serum and saliva levels of mycophenolic acid (MPA) for patients taking Mycophenolate Sodium and Mycophenolate Mofetil f ollowing heart transplantation and lung transplantation.At the end of 12 months we will have the ability to correlate MPA exposure (as defined by area-under-the-curve [AUC]) with clinical and laboratory outcomes (e.g. leucopaenia) in a real-world where we have dosed Mycophenolate Sodium and Mycophenolate Mofetil as per our current protocol and as tolerated by white blood cell count (WBC) and symptoms, but the analysis should give us insights to help predict and prevent some of the issues which will have arisen during the 12 month study (Leukopenia, Rejection, GI intolerance), and ultimately assess the potential use of therapeutic drug monitoring. Mycophenolic acid will be measured in blood and saliva using a validated high performance liquid chromatography (HPLC) method. In simple terms the primary endpoint is : To assess for correlation between drug exposure as measured by area under the curve and patient symptoms of Leukopenia, Rejection, GI Intolerance.	—

Measure

Time frame

Secondary Objective: Also correlating MPA levels with side effects such as nausea/vomiting/diarrhoea (all patients will receive a questionnaire for GI side effects at weekly intervals for first month and monthly thereafter). ; Main Objective: An observational study of MPA levels in peripheral blood and saliva of Heart Transplant and Lung Transplant patients (average of 35 transplants/yr) • Mini-area under the curve (AUC) [AUC 3 point approximation using 0, 30 and 120 minutes after morning intake] as per recent study by Doesch et al (Protocol ref 4). This study would be observational in terms of watching clinical course (rejection, infection including both bacterial, viral & fungal episodes) ; Primary end point(s): We will measure serum and saliva levels of mycophenolic acid (MPA) for patients taking Mycophenolate Sodium and Mycophenolate Mofetil f ollowing heart transplantation and lung transplantation.At the end of 12 months we will have the ability to correlate MPA exposure (as defined by area-under-the-curve [AUC]) with clinical and laboratory outcomes (e.g. leucopaenia) in a real-world where we have dosed Mycophenolate Sodium and Mycophenolate Mofetil as per our current protocol and as tolerated by white blood cell count (WBC) and symptoms, but the analysis should give us insights to help predict and prevent some of the issues which will have arisen during the 12 month study (Leukopenia, Rejection, GI intolerance), and ultimately assess the potential use of therapeutic drug monitoring. Mycophenolic acid will be measured in blood and saliva using a validated high performance liquid chromatography (HPLC) method. In simple terms the primary endpoint is : To assess for correlation between drug exposure as measured by area under the curve and patient symptoms of Leukopenia, Rejection, GI Intolerance.

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Countries

United Kingdom

Outcome results

None listed

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