Renal impairment following heart transplantation MedDRA version: 9.1 Level: LLT Classification code 10010184 Term: Complications of transplanted heart
Conditions
Interventions
Trade Name: Myfortic
Product Name: Mycophenolic acid
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
University Hospital of South Manchester NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stable patients more than 6 months after heart transplantation, receiving immunosuppression based on cyclosporine or tacrolimus. 2. Moderate renal impairment - serum creatinine 150-220 micro mol/l or GFR (glomerular filtration rate) 30-59, in the 3 months period prior to enrolment in the study. 3. Patients who have given written informed consent to take part in the study. 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: 1. Acute rejection (grade 3a or above from the ISHLT criteria) requiring treatment in the last 3 months. 2. Alternative causes for renal dysfunction (e.g. renal obstruction, small kidneys or other gross abnormalities). 3. Females of childbearing potential who are planning to become pregnant, who are pregnant who are unwilling to use effective means of contraception. Patients should use a reliable medically approved method of contraception during the trial period. If unwilling or unable to use a medically approved reliable form of contraception then patients should abstain from penetrative sex. It is recommended that MMF or Myfortic therapy should not be initiated until a negative pregnancy test has been obtained. Effective contraception must be used before beginning MMF / Myfortic therapy, during therapy, and for six weeks following discontinuation of therapy. Patients should be instructed to consult their physician immediately should pregnancy occur. The use of MMF / Myfortic is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available. MMF / Myfortic should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus. There are no adequate data from the use of MMF / Myfortic in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats. It is not known whether this substance is excreted in human milk. Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, MMF / Myfortic are contraindicated in nursing mothers. 4. Pre-existing severe cardiac allograft dysfunction (LVEF 1g/24hrs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of kidney function 6 months following the introduction of trial medication. ; Secondary Objective: • Efficacy: improvement of renal function at 12 months, treated acute rejection episodes. • Safety of the trial medications by reduction in adverse events (including infection, haematological and gastrointestinal effects, bleeding, skin rash, pneumonitis, any cause of hospitalization for treatment, death), cardiovascular risk factors, and standard laboratory assessments ;Primary end point(s): To show an improvment in renal function at 6 months following the introduction of trial medication ( in the low dose ciclosporin group). | — |
Countries
United Kingdom
Outcome results
None listed