Introduction of everolimus is associated with a reduction in the dosage of calcineurine-inhibitors in patients with a pulmonary graft who suffer from a notable chronic renal insuffisance.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001945-32-BE

Enrollment

Registered

2006-10-25

Start date

2006-11-13

Completion date

Unknown

Last updated

2022-03-14

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

Conditions

Patient who received a pulmonary transplant and who show notable renale insuffisance (DFG 50% DGF in 3 months) and isotopical glomerural filtration < 45 ml/min.

Interventions

Trade Name: certican Product Name: everolimus Pharmaceutical Form: Capsule* INN or Proposed INN: certican Concentration unit: mg milligram(s) Concentration number: 0,25- Trade Name: certican Product

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)introduction of a severe chronical renal insufficience(CRI) (DFG 50 % DFG in 3 months) en isotopic glomerular filtration =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Recent severe rejection (the last 6 months) 2) recent severe infections (the last 6 months) 3) active hepatic pathology 4) Coronaropathie in the cardiac transplant in case of a heart-lung transplant 5) Uncontrolled Reflux 6) hématological anomalies : leucopenie ( 240 mg% 8) glomerular Filtration < 25 ml / ‘ / 1.73 m2

Design outcomes

Primary

Measure	Time frame
Main Objective: documenting the impact of everolimus on renal function in pulmonary transplant patients presenting chronic renal insufficiency;Secondary Objective: documenting the impact of sirolimus or everolimus on the appearance of severe rejection and/or bronchiolitis obliterans syndrome after a pulmonary transplantation.;Primary end point(s): EFR - PK ou C3 Prograft (si PK pas fait) - Holter TA - Profil lipidic - HbA1C - Echo rénal - EMU-culture - urinary strips - determination of BK polyomavirus in urine - Protéinurie determination on morning sample(rapport protéines/créatinine) - Filtration glomérulaire isotopique	—

Measure

Time frame

Main Objective: documenting the impact of everolimus on renal function in pulmonary transplant patients presenting chronic renal insufficiency;Secondary Objective: documenting the impact of sirolimus or everolimus on the appearance of severe rejection and/or bronchiolitis obliterans syndrome after a pulmonary transplantation.;Primary end point(s): EFR - PK ou C3 Prograft (si PK pas fait) - Holter TA - Profil lipidic - HbA1C - Echo rénal - EMU-culture - urinary strips - determination of BK polyomavirus in urine - Protéinurie determination on morning sample(rapport protéines/créatinine) - Filtration glomérulaire isotopique

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Countries

Belgium

Outcome results

None listed

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