Status:
COMPLETED
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Lung Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment
- Exclusion criteria:
- Patients with thrombocytopenia (platelets \<100,000/mm³), with an absolute neutrophil count of \<1,500/mm³ or leucopenia (leucocytes \<3000/mm³), with anemia with Hb \< 8g/dl at time of screening
- Patients with uncontrolled hypercholesterolemia (\> 350 mg/dL; \> 9.1 mmol/L) or hypertriglyceridemia (\> 750 mg/dL; \> 8.5 mmol/L) at time of screening
- Patients with a history of malignancy of any organ system, treated or untreated, during the last five years, whether or not there is evidence of local recurrence or metastases, except squamous or basal cell carcinoma of the skin Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2017
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT01404325
Start Date
February 1 2012
End Date
January 5 2017
Last Update
March 14 2019
Active Locations (9)
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1
Novartis Investigative Site
Berlin, Germany, 10117
2
Novartis Investigative Site
Berlin, Germany, 13353
3
Novartis Investigative Site
Essen, Germany, 45147
4
Novartis Investigative Site
Freiburg im Breisgau, Germany, 79106