Immunosuppressive Therapy With Certican (Everolimus) Afte... | NCT00402532

Studies
Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

NCT00402532

Sponsor

Hannover Medical School

Status

Completed

Last Update Posted

Dec 8, 2011Estimated

Enrollment

190Actual

Phase

Phase 3

Conditions

Lung Transplantation

Interventions

Everolimus
Mycophenolatmofetil

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Nov 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Nov 20, 2006

First Submission Date that Met QC Criteria

Nov 20, 2006

First Posted Date

Nov 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2011

Last Update Posted Date

Dec 8, 2011Estimated

Name	Class
Novartis Pharmaceuticals	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

190Actual

Label	Type	Description	Intervention Names
Everolimus	Active Comparator		Drug: Everolimus
Mycophenolatmofetil	Active Comparator		Drug: Mycophenolatmofetil

Name	Type	Description	Arm Group Labels	Other Names
Everolimus	Drug	Initial dosage 2 x 0.75 mg/d	Everolimus	Certican

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation		2 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence and severity of Nephrotoxicity within 2 years of transplantation		2 years
Incidence and severity of opportunistic infections within 2 years of transplantation		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recipient of Single or Bilateral Lung Transplantation
Informed consent
Recipients who are able to receive Everolimus at week 3 after Lung Transplantation
women of childbearing potential must have a negative pregnancy test within 48 hours of enrolment
women of childbearing potential must use appropriate contraceptive method at enrolment, during the study and up to 8 weeks after the end of the study
donor must not have relevant pulmonary diseases
donor must have oxygen partial pressure higher than 300 mmHg at FiO 1.0 and positive end-expiratory pressure of 5 cm H2O.

Exclusion Criteria:

systemic infection of the donor
donor: signs or symptoms of aspiration
donor: severe pulmonary injury or contusion
donor: malignant neoplasm of the lung
donor: HIV positive
recipients who receive immunosuppressive agents not used in this protocol
recipients who participated within 30 days before study start or are currently participating in another investigational drug trial
HIV positive recipient
systemic infection of the recipient
recipients of combined/ multiple transplantations
pregnancy of the recipient
recipients with signs/ Symptoms of impaired wound healing of the pulmonary anastomoses
recipients who are still on artificial respiration or who are not able to swallow tablets at week 3 after transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Martin Strueber, Dr.	Hannover Medical School	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School, Division of Thoracic and Cardiovascular Surgery		Hanover		30625	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001989	Bronchiolitis Obliterans
D009894	Opportunistic Infections

Ancestor Terms

ID	Term
D001988	Bronchiolitis
D001991	Bronchitis
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208

ID	Term
D000068338	Everolimus
D009173	Mycophenolic Acid