Prospective Open Single-Centre Study on the Effect of Initiation of RAD and CNI minimalisation on renal function in heart transplant patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000222-22-BE

Enrollment

Registered

2005-07-04

Start date

2005-04-25

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

heart transplant patients with impaired renal function under treatment of CNI

Interventions

Trade Name: Everolimus 0,25 mg Pharmaceutical Form: Trade Name: Everolimus 0,5 mg Pharmaceutical Form: Trade Name: Everolimus 0,75 mg Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: - suspected non-compliance - intolerance for RAD or STATINS - life expectancy 1.5 g/24h/ 1.73 m² - previous sirolimus treatment - obvious other reasons for renal failure

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Belgium

Outcome results

None listed

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