Clinical trial NCT01292226: A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
Official title: Relationships Between Pharmacokinetic and Pharmacodynamic Strategies for Assessment of the Risks for Acute Rejection and Side Effects of Mycophenolate Mofetil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-02-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the correlation between the pharmacokinetic and pharmacodynamic parameters of CellCept in patients undergoing primary kidney transplantation, in order to assess the impact on clinical outcome and the risks of acute rejection. All patients will receive oral CellCept, 1g twice daily, and pharmacokinetic and pharmacodynamic parameters will be measured at weeks 2, 4, 12 and 24. The anticipated time on study treatment is 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 18 to 65 years of age
* Patients undergoing primary kidney transplantation

Exclusion Criteria:

* Recipients of multiple organ transplants
* Prior therapy with CellCept
* Presence or history of malignancies, except for successfully treated basal or squamous cell carcinoma of the skin
* Active peptic ulcer or active serious digestive system disease that may affect the absorption of CellCept

Primary outcomes:
measure: Percentage of Participants With Acute Rejection
timeFrame: Day 1, Weeks 2, 4, 12, 24, and 28
measure: Time to Rejection
timeFrame: Day 1, Weeks 2, 4, 12, 24, and 28
measure: Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR)
timeFrame: Day 1, Weeks 2, 4, 12, 24, and 28
Secondary outcomes:
measure: Percentage of Participants With Graft Loss
timeFrame: Day 1, Weeks 2, 4, 12, 24, and 28
measure: Percentage of Participants Surviving
timeFrame: Day 1, Weeks 2, 4, 12, 24, and 28
measure: Total Mycophenolate Acid (MPA) by Visit and Timepoint
timeFrame: Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up Visit), and any unscheduled visits
measure: Free MPA (mcg/mL) by Visit
timeFrame: Weeks 2, 4, 12, 24, safety follow-up (Week 28), and any unscheduled visits
measure: MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit
timeFrame: Predose and 40 minutes and 2 hours postdose at Weeks 2, 4, 12, and 24, and at the Safety follow-up (Week 28)
measure: Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint
timeFrame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
measure: IMPDH Expression I by Visit and Timepoint
timeFrame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
measure: IMPDH Expression II by Visit and Timepoint
timeFrame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
measure: Interleukin 8 (IL-8) Expression by Visit and Timepoint
timeFrame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
measure: Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint
timeFrame: BL and Weeks 2, 4, 12, and 24, and safety follow-up (Week 28) and any unscheduled visits
measure: Percentage of Participants With Infection
timeFrame: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
measure: Percentage of Participants With Gastrointestinal Toxicities
timeFrame: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-up Visit)
measure: Percentage of Participants With Hematologic Toxicity
timeFrame: BL and Weeks 2, 4, 12, 24, and 28 (Safety Follow-Up)
measure: Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity
timeFrame: BL and Weeks 2, 4, 12, and 24
measure: Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity
timeFrame: BL and Weeks 2, 4, 12, and 24
Other outcomes:
Locations:
city: Bari
country: Italy
city: Brescia
country: Italy
city: Coppito
country: Italy
city: Napoli
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Verona
country: Italy
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: