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.

Phase 1

• Conditions: Patient who received a pulmonary transplant and who show notable renale insuffisance (DFG < 50ml/min/1.73m²) which has been progressive over the last two years or chronical renal insuffisance which progresses fast (a los of >50% DGF in 3 months) and isotopical glomerural filtration < 45 ml/min.

• Registration Number: EUCTR2006-001945-32-BE
• Lead Sponsor: B Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-25
• Study Completion: 2008-02-29
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1)introduction of a severe chronical renal insufficience(CRI) (DFG < 50 ml/min/1.73 m2) which was progressive during the last 2 years or CRI which rapidely progresses (a loss of > 50 % DFG in 3 months) en isotopic glomerular filtration < 45 ml/min
even when the following changes:
a)switch from cyclosporine A (Neoral) to tacrolimus (Prograft)
b)Optimalisation of prograft dosage (minimum 1 profil PK that shows an AUC0-12h between 100 – 200 ?g/h/l or at least 3 dosages C3 that show a level between 10 and 20 ng/ml)
c)Optimalisation of immunosuppression by introduction of azathioprine (Imuran) or mycophénolate mofétil (Cellcept)
d)HTA in balance (Holter TA récent, < 130/90 mmHg in the absence of protéinurie, < 120/80 mmHg in the présence of protéinurie)
e)correctly treated diabetes (HbA1c < 7 % récente)

2)Absence of recent severe rejection (6 mois) and/or progressive BOS

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

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 (< 4000/mm3), anémie (hémoglobine < 7 gr %), thrombocytopénie (platelets < 150.000 / mm3)
7)fasting Cholesterol > 240 mg%
8)glomerular Filtration < 25 ml / ‘ / 1.73 m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>-PK ou C3 Prograft (si PK pas fait)<br>-Holter TA<br>-Profil lipidic<br>-HbA1C<br>-Echo rénal<br>-EMU-culture<br>-urinary strips<br>-determination of BK polyomavirus in urine<br>-Protéinurie determination on morning sample(rapport protéines/créatinine)<br>-Filtration glomérulaire isotopique<br>