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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01014442
First received: November 16, 2009
Last updated: July 22, 2015
Last verified: July 2015
  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
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 ]

Enrollment: 70
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MMF; Cystic Fibrosis
Participants with cystic fibrosis received mycophenolate mofetil (MMF) 1.5 grams (g), orally (PO), twice per day (BID, from Days through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation.
Drug: mycophenolate mofetil
1.5 g PO BID from Days 1 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation
Other Name: CellCept
Experimental: MMF; Other
Participants with chronic obstructive pulmonary disease (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), or alpha-1 antitrypsin deficiency (A1AD) received MMF 1.5 g, PO, BID, from Days through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation.
Drug: mycophenolate mofetil
1.5 g PO BID from Days 1 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation
Other Name: CellCept

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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

Responsible Party: 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: July 22, 2015
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

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

ClinicalTrials.gov processed this record on September 29, 2016