Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2006-001945-32-BE
EUCTR2006-001945-32-BE
Active, not recruiting
Phase 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 enrollmentOctober 25, 2006
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPatient 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.
Drugscertican

Overview

Phase
Phase 1
Intervention
Not specified
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.
Sponsor
B Erasme
Enrollment
15
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 25, 2006
End Date
February 29, 2008
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
B Erasme

Eligibility Criteria

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:

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Not Applicable
Clinical effects of everolimus in the subjects with autism spectrum disprders (ASD) in relation to tuberous sclerosis.there are a few individuals with TSC with SEGA who exhibite ASD symptoms.
JPRN-jRCT1090220258Kunio Yui20
Recruiting
Not Applicable
The assessment of the response to everolimus of renal cell carcinoma by FDG PET/CT and its impact on prognosisadvanced renal cell carcinoma (RCC)
JPRN-UMIN000011570Yokohama City University30
Active, not recruiting
Phase 1
Everolimus (RAD001) in combination with intravenous carboplatin in taxane- and anthracycline-pretreated patients with progressive metastatic breast cancer - RAD001 and carboplatin in pretreated metastatic breast cancer
EUCTR2008-006055-52-DECharité - University Hospital of Berlin58
Active, not recruiting
Phase 1
Activity and safety of Everolimus in combination with octreotide LAR and Metformin in patients with advanced pancreatic well-differentiated Neuroendocrine Tumors (pWDNETs): a Phase II, open, monocentric, prospective study.advanced/ or not resectable well differnciated pancreatic neuroendocrin tumorMedDRA version: 16.1Level: LLTClassification code 10067518Term: Pancreatic neuroendocrine tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 16.1Level: PTClassification code 10068909Term: Pancreatic neuroendocrine tumour metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2014-000888-41-ITFondazione IRCCS Istituto Nazionale dei tumori43
Active, not recruiting
Phase 1
EVINEC: Safety and Tolerability of Everolimus as second-line treatment in poorly differentiated neuroendocrine carcinoma / neuroendocrine carcinoma G3 according to WHO 2010 and neuroendocrine tumor G3 - an investigtor initiated Phase II study.• Poorly differentiated neuroendocrine carcinoma, neuroendocrine carcinoma G3 (NEC G3 according to WHO 2010) with primary tumor outside lung• Well to moderately differentiated neuroendocrine carcinoma (NET G1/G2) that switched to G3 (confirmed by histology)• Neuroendocrine tumor G3 (NET G3)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2012-004550-28-DEAIO-Studien-gGmbH