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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404325
First Posted: July 28, 2011
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Crolll Gmbh
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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: None (Open Label)
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 ( Novartis Pharmaceuticals ):

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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404325


Locations
Germany
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
Investigators
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01404325     History of Changes
Other Study ID Numbers: CRAD001ADE36
2011-001539-21 ( EudraCT Number )
First Submitted: July 13, 2011
First Posted: July 28, 2011
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
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 www.clinicalstudydatarequest.com.

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

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Lung transplantation
everolimus
kidney function

Additional relevant MeSH terms:
Everolimus
Sirolimus
Immunosuppressive Agents
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents