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Completed

NCT Number: NCT00402532

Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

The purpose of this study is to determine whether Everolimus is effective in the treatment and prevention of chronic graft dysfunction and chronic graft rejection after lung transplantation.

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Key information

Conditions

Lung Transplantation Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Opportunistic Infections Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hannover Medical School, Division of Thoracic and Cardiovascular Surgery

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

Initial dosage 2 x 0.75 mg/d

Other names: Certican

Mycophenolatmofetil

Drug

Initial dosage 2 x 500 mg/d intravenous

Other names: Cellcept

Primary outcomes

  1. Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation

    Time frame: 2 years

Secondary outcomes

  1. Incidence and severity of Nephrotoxicity within 2 years of transplantation

    Time frame: 2 years

  2. Incidence and severity of opportunistic infections within 2 years of transplantation

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2006
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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