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Clinical Trials/EUCTR2006-001945-32-BE
EUCTR2006-001945-32-BEActive, not recruitingPhase 1

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.

B Erasme0 sites15 target enrollmentStarted: October 25, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
15
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
B Erasme

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