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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Novartis
Sponsor:
Collaborator:
Crolll Gmbh
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01404325
First received: July 13, 2011
Last updated: July 17, 2014
Last verified: July 2014
  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: 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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of acute rejection episodes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • The incidence of, and time to progression of Bronchiolitis obliterans syndrome (BOS) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • incidence of death [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Exercise capacity (6MWT) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Incidence of retransplantation [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 232
Study Start Date: February 2012
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01404325

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Germany
Novartis Investigative Site Completed
Berlin, Germany, 10117
Novartis Investigative Site Recruiting
Berlin, Germany, 13353
Novartis Investigative Site Recruiting
Essen, Germany, 45147
Novartis Investigative Site Recruiting
Freiburg, Germany, 79106
Novartis Investigative Site Recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Novartis Investigative Site Not yet recruiting
Homburg, Germany, 66421
Novartis Investigative Site Withdrawn
Leipzig, Germany, 04103
Novartis Investigative Site Recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Not yet recruiting
Marburg, Germany, 35039
Novartis Investigative Site Recruiting
Muenchen, Germany, 81377
Sponsors and Collaborators
Novartis Pharmaceuticals
Crolll Gmbh
Investigators
Study Director: Novartis Pharmceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01404325     History of Changes
Other Study ID Numbers: CRAD001ADE36, 2011-001539-21
Study First Received: July 13, 2011
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by Novartis:
Lung transplantation
everolimus
kidney function

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

ClinicalTrials.gov processed this record on July 29, 2014