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Completed

NCT Number: NCT01014442

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

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.

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Key information

Conditions

Lung Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Cardiothoracic, Transplantation and Vascular Surgery at Hannover Medical School

Hanover, 30625, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Mycophenolate mofetil

Drug

1.5 g PO BID from Days 2 to 30 post-transplantation, 1 g PO BID Days 31 to 90 post-transplantation

Other names: CellCept

Primary outcomes

  1. Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 after transplantation

    Cmax was expressed in milligrams per liter (mg/L).

  2. Cmax of MPA, MPAG and AcMPAG at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

    Cmax was expressed in mg/L.

  3. Cmax of MPA, MPAG and AcMPAG at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

    Cmax was expressed in mg/L.

  4. Cmax of MPA, MPAG and AcMPAG at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

    Cmax was expressed in mg/L.

  5. Cmax of Free MPA at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

    Cmax was expressed in micrograms per liter (mcg/L).

  6. Cmax of Free MPA at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

    Cmax was expressed in mcg/L.

  7. Cmax of Free MPA at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

    Cmax was expressed in mcg/L.

  8. Cmax of Free MPA at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

    Cmax was expressed in mcg/L.

  9. Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

    Dose-normalized Cmax was determined (in 1 per liter [1/L]) by dividing the Cmax by the actual dose taken.

  10. Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

    Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.

  11. Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

    Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.

  12. Dose-Normalized Cmax of MPA, MPAG, AcMPAG and Free MPA at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

    Dose-normalized Cmax was determined (in 1/L) by dividing the Cmax by the actual dose taken.

  13. Time to Maximum Concentration (Tmax) of MPA, MPAG, AcMPAG and Free MPA at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

  14. Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

  15. Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

  16. Tmax of MPA, MPAG, AcMPAG and Free MPA at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

  17. Minimum Concentration (Cmin) of MPA, MPAG and AcMPAG at Day 4

    Time frame: Predose (0 hour) on Day 4 post-transplantation

    Cmin was expressed in mg/L.

  18. Cmin of MPA, MPAG and AcMPAG at Day 8

    Time frame: Predose (0 hour) on Day 8 post-transplantation

    Cmin was expressed in mg/L.

  19. Cmin of MPA, MPAG and AcMPAG at Day 20

    Time frame: Predose (0 hour) on Day 20 post-transplantation

    Cmin was expressed in mg/L.

  20. Cmin of MPA, MPAG and AcMPAG at Day 90

    Time frame: Predose (0 hour) on Day 90 post-transplantation

    Cmin was expressed in mg/L.

  21. Cmin of Free MPA at Day 4

    Time frame: Predose (0 hour) on Day 4 post-transplantation

    Cmin was expressed in mcg/L.

  22. Cmin of Free MPA at Day 8

    Time frame: Predose (0 hour) on Day 8 post-transplantation

    Cmin was expressed in mcg/L.

  23. Cmin of Free MPA at Day 20

    Time frame: Predose (0 hour) on Day 20 post-transplantation

    Cmin was expressed in mcg/L.

  24. Cmin of Free MPA at Day 90

    Time frame: Predose (0 hour) on Day 90 post-transplantation

    Cmin was expressed in mcg/L.

  25. Volume of Distribution (Vz) of MPA, MPAG and AcMPAG at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

    Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

  26. Vz of MPA, MPAG and AcMPAG at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

    Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

  27. Vz of MPA, MPAG and AcMPAG at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

    Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

  28. Vz of MPA, MPAG and AcMPAG at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

    Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

  29. Clearance (CL) of MPA, MPAG and AcMPAG at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

    CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in liters per hour (L/hour).

  30. CL of MPA, MPAG and AcMPAG at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

    CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.

  31. CL of MPA, MPAG and AcMPAG at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

    CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.

  32. CL of MPA, MPAG and AcMPAG at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

    CL is a quantitative measure of the rate at which a drug substance is removed from the body and expressed in L/hour.

  33. Area Under the Curve From Time 0 to 12 Hours (AUC0-12) of MPA, MPAG and AcMPAG at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours time milligrams per liter (hours*[mg/L]).

  34. AUC0-12 of MPA, MPAG and AcMPAG at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).

  35. AUC0-12 of MPA, MPAG and AcMPAG at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).

  36. AUC0-12 of MPA, MPAG and AcMPAG at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mg/L).

  37. AUC0-12 of Free MPA at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours times micrograms per liter (hours*[mcg/L]).

  38. AUC0-12 of Free MPA at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).

  39. AUC0-12 of Free MPA at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).

  40. AUC0-12 of Free MPA at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours and expressed in hours*(mcg/L).

  41. Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.

  42. Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.

  43. Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.

  44. Dose-Normalized AUC0-12 of MPA, MPAG, AcMPAG and Free MPA at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

    AUC0-12 is a measure of the serum concentration of the drug from time 0 to 12 hours. Dose-normalized AUC0-12 was determined (in hours/L) by dividing the AUC0-12 by the actual dose taken.

  45. Free Fraction of Free MPA at Day 4

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 4 post-transplantation

    MPA Free fraction (in percent [%]) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.

  46. Free Fraction of Free MPA at Day 8

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 8 post-transplantation

    MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.

  47. Free Fraction of Free MPA at Day 20

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 20 post-transplantation

    MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.

  48. Free Fraction of Free MPA at Day 90

    Time frame: Predose (0 hour), 0.5, 1, 1.5, 2, 4, 8, 10, and 12 hours post-dose on Day 90 post-transplantation

    MPA Free fraction (in %) was calculated by dividing free MPA AUC0-12 by total MPA AUC0-12 times 100%.

Secondary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1) at Day 90 Post-Transplantation

    Time frame: Day 90 post-transplantation

    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.

  2. Percent of Predicted FEV1 at Day 90 Post-Transplantation

    Time frame: Day 90 post-transplantation

    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Percent predicted FEV1 [%] = (FEV1 [L] / Predicted normal value FEV1 [L]) * 100%

  3. Forced Vital Capacity (FVC) at Day 90 Post-Transplantation

    Time frame: Day 90 post-transplantation

    FVC at Day 90 post-transplantation is reported.

  4. Change From Baseline in Intracellular Adenosine-Tri-Phosphate (iATP) Levels

    Time frame: Baseline, Days 4, 8, 20 and 90 post-transplantation

    iATP was expressed in ng/mL.

  5. Change From Baseline in T-Cell Phenotype

    Time frame: Baseline, Days 20 and 90 post-transplantation

    Reported values are change in the T-cell phenotype status from baseline to Day 20 and 90 for cluster of differentiation (CD) 3, CD19, CD4, CD4CD25, CD28, CD45RA, CD45RO, CD69, CD127, and CD152.

  6. Percentage of Participants With Opportunistic Infections

    Time frame: Up to Day 90

    Opportunistic infections included all infections which occurred due to aspergillus, candida, pneumocystis, cryptococcus, listeria, herpes zoster, herpes simplex, cytomegalovirus pathogens.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Pharmacokinetics of Mycophenolate Mofetil in de Novo Lung Allograft Recipients

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 17, 2009
Registry last updated
Feb 10, 2017

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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