EUCTR2005-000222-22-BEActive, not recruitingNot Applicable
Prospective Open Single-Centre Study on the Effect of Initiation of RAD and CNI minimalisation on renal function in heart transplant patients
OLV-ziekenhuis0 sitesStarted: July 4, 2005Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- 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
Exclusion Criteria
- •- 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
Investigators
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