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

Roche

Status and phase: Completed; Phase 3

Conditions: Lung Transplantation

Treatments: Drug: mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014442

ML22608

2009-012231-15

Details and patient eligibility

About

This open-label, single center study will assess the pharmacokinetics, efficacy and safety of mycophenolate mofetil in lung allograft recipients. Participants will be split into 2 groups according to the original disease: Group A (cystic fibrosis) and Group B (chronic obstructive pulmonary disease [COPD], emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency [A1AD]). All participants will receive mycophenolate mofetil orally, 1.5 grams (g) twice daily (BID) from Day 2 to 30 post transplantation, and 1 g BID from Day 31 to 90 post transplantation. Anticipated time on study treatment is 90 days, and target sample size is 50-100 individuals.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary single or bilateral lung allograft
• original disease cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or A1AD

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Mycophenolate Mofetil; Cystic Fibrosis

Experimental group

Description:

Participants with cystic fibrosis will receive mycophenolate mofetil 1.5 g, orally (PO), BID from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation.

Treatment:

Drug: mycophenolate mofetil

Mycophenolate Mofetil; Other

Experimental group

Description:

Participants with COPD, emphysema, idiopathic pulmonary fibrosis, or A1AD will receive mycophenolate mofetil 1.5 g, PO, BID, from Days 2 through 30 post-transplantation, and 1 g, PO, BID from Days 31 through 90 post-transplantation.

Treatment:

Drug: mycophenolate mofetil