Efficacy of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients (4EVERLUNG)
This study is currently recruiting participants.
Verified January 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Collaborator:
Crolll Gmbh
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01404325
First received: July 13, 2011
Last updated: January 18, 2013
Last verified: January 2013
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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 |
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: | 300 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | November 2015 (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
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404325
Contacts
| Contact: Novartis Pharmaceuticals | 41613241111 |
Locations
| Germany | |
| Novartis Investigative Site | Recruiting |
| Berlin, Germany | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative Site | Recruiting |
| Essen, Germany | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative Site | Not yet recruiting |
| Freiburg, Germany | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative Site | Not yet recruiting |
| Grosshadern, Germany | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative Site | Recruiting |
| Hamburg, Germany | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative Site | Recruiting |
| Hannover, Germany | |
| Contact: Novartis Pharmaceuticals 41613241111 | |
| Novartis Investigative Site | Withdrawn |
| Leipzig, Germany | |
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: | January 18, 2013 |
| Health Authority: | 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 May 16, 2013