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Efficacy of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients (4EVERLUNG)

This study has been completed.
Crolll Gmbh
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: July 13, 2011
Last updated: April 20, 2017
Last verified: April 2017
This trial will evaluate the efficacy of Everolimus in combination with a centre specific standard immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.

Condition Intervention Phase
Lung Transplantation
Drug: standard therapy
Drug: Everolimus (RAD001) as add-on
Drug: RAD001
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A 2-arm, Prospective, Randomized, Controlled, Open-label, 12 Month Phase III Trial to Evaluate the Efficacy of Everolimus in Combination With a Centre Specific Standard Immunosuppressive Regimen Consisting of CNI, MPA and Steroids Versus a Standard Triple Immunosuppressive Regimen in Lung Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function measured by calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula at 12 months [ Time Frame: 12 months after randomization ]

Secondary Outcome Measures:
  • incidence of acute rejection episodes [ Time Frame: 6 and 12 months ]
  • The incidence of, and time to progression of Bronchiolitis obliterans syndrome (BOS) [ Time Frame: 6 and 12 months ]
  • incidence of death [ Time Frame: 6 and 12 months ]
  • Exercise capacity (6MWT) [ Time Frame: 6 and 12 months ]
  • Incidence of retransplantation [ Time Frame: 6 and 12 months ]

Enrollment: 131
Actual Study Start Date: February 1, 2012
Study Completion Date: January 5, 2017
Primary Completion Date: January 5, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
centre specific CNI-based triple drug immunosuppression
Drug: standard therapy
centre specific CNI-based triple drug immunosuppression
Experimental: Arm 2
quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids
Drug: Everolimus (RAD001) as add-on
quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids
Drug: RAD001


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Adult recipients of de novo cadaveric lung transplants

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 (>330mg/dL; >9mmol/L) or hypertriglyceridemia (>300 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01404325

Novartis Investigative Site
Berlin, Germany, 10117
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Homburg, Germany, 66421
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Muenchen, Germany, 81377
Sponsors and Collaborators
Novartis Pharmaceuticals
Crolll Gmbh
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01404325     History of Changes
Other Study ID Numbers: CRAD001ADE36
2011-001539-21 ( EudraCT Number )
Study First Received: July 13, 2011
Last Updated: April 20, 2017
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis:
Lung transplantation
kidney function

Additional relevant MeSH terms:
Immunosuppressive Agents
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on May 24, 2017