A Study of CellCept (Mycophenolate Mofetil) in Lung Transplant Recipients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Hoffmann-La Roche.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01014442
First received: November 16, 2009
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

This open-label, single center study will assess the pharmacokinetics, efficacy and safety of Cellcept in lung allograft recipients. Patients will be split into 2 groups according to the original disease: group A (cystic fibrosis) and group B (chronic obstructive pulmonary disease, emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency). All patients will receive CellCept orally, 1.5g twice daily on days 1-30 post transplantation, and 1g twice daily on days 31-90. Anticipated time on study treatment is 90 days, and target sample size is 50-100 individuals.


Condition Intervention Phase
Lung Transplantation
Drug: mycophenolate mofetil [CellCept]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Mycophenolate Mofetil in de Novo Lung Allograft Recipients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics and metabolic ratios: Cmax, Tmax, Cmin, V2, AUC for MPA, MPAG, AcMPAG and free MPA [ Time Frame: days 4, 8, 20 and 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: pulmonary function, alloimmune status, peripheral T-cell phenotype [ Time Frame: days 4, 8, 20 and 90, pulmonary function day 90 ] [ Designated as safety issue: No ]
  • Safety: AEs, laboratory parameters, opportunistic infections [ Time Frame: throughout study, laboratory assessments days 4, 8, 20 and 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A:cystic fibrosis Drug: mycophenolate mofetil [CellCept]
1.5g po twice daily days 1-30 post transplantation, 1g po twice daily days 31-90
Experimental: B:other Drug: mycophenolate mofetil [CellCept]
1.5g po twice daily days 1-30 post transplantation, 1g po twice daily days 31-90

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • primary single or bilateral lung allograft
  • original disease cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or alpha-1 antitrypsin deficiency

Exclusion Criteria:

  • lung allograft retransplantation
  • multiple organ transplantation
  • severe gastrointestinal disorder
  • malignancies or history of malignancy
  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: NCT01014442

Contacts
Contact: Please reference Study ID Number: ML22608 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Germany
Recruiting
Hannover, Germany, 30625
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01014442     History of Changes
Other Study ID Numbers: ML22608, 2009-012231-15
Study First Received: November 16, 2009
Last Updated: December 7, 2011
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014