Prospective Open Single-Centre Study on the Effect of Initiation of RAD and CNI minimalisation on renal function in heart transplant patients
- Conditions
- heart transplant patients with impaired renal function under treatment of CNI
- Registration Number
- EUCTR2005-000222-22-BE
- Lead Sponsor
- OLV-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- age > or = 18 year
- informed consent
- 1 to 10 year heart transplantation
- stable heart allograft function without rejection for at least 12 months
- same IS drugs for at least 6 months
- cyclosporin based IS, with C2 > 300
- poor renal function: eGFR between 25-60 mL/min AND/OR 'creeping creatinin ' i.e. an increase of serum creatinin > 15%/year.
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) yes
F.1.3.1 Number of subjects for this age range
- suspected non-compliance
- intolerance for RAD or STATINS
- life expectancy < 1 year.
- proteinuria > 1.5 g/24h/ 1.73 m²
- previous sirolimus treatment
- obvious other reasons for renal failure
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the evolution of the renal function after initiation of RAD and minimalisation of CNI;Secondary Objective: ;Primary end point(s): renal function
- Secondary Outcome Measures
Name Time Method