Phase 2
Completed N=45
A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).
Source: ClinicalTrials.gov NCT01292226 ↗Enrolled (actual)
45
Serious AEs
44.4%
Results posted
Mar 2015
Primary outcomePrimary: Percentage of Participants With Acute Rejection — 9.1 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Acute Rejection |
9.1 | — |
| PRIMARY Time to Rejection |
23.67 | — |
| PRIMARY Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) |
4.5 | — |
| SECONDARY Percentage of Participants With Graft Loss |
2.3 | — |
| SECONDARY Percentage of Participants Surviving |
97.7 | — |
| SECONDARY Total Mycophenolate Acid (MPA) by Visit and Timepoint |
1.75; 1.87; 1.79; 1.90; 1.16; 1.32 | — |
| SECONDARY Free MPA (mcg/mL) by Visit |
0.03; 0.04; 0.03; 0.03; 0.01; 0.04 | — |
| SECONDARY MPA Area Under the Concentration - Time Curve From Time 0 to 12 Hours (AUC0-12) (mcg/mL) by Visit |
38.3; 39.7; 39.7; 39.8; 29.7 | — |
| SECONDARY Inosine MonoPhosphate DeHydrogenase (IMPDH) Activity by Visit and Timepoint |
5.01; 3.96; 3.89; 6.74; 9.58; 0 | — |
| SECONDARY IMPDH Expression I by Visit and Timepoint |
2.32; 32.29; 3.16; 4.10; 1.95; 11803.48 | — |
| SECONDARY IMPDH Expression II by Visit and Timepoint |
115.33; 113.43; 117.16; 112.43; 114.21; 123.86 | — |
| SECONDARY Interleukin 8 (IL-8) Expression by Visit and Timepoint |
4532.72; 29960.41; 54101.30; 1829.87; 10391.60; 1254.29 | — |
| SECONDARY Tumor Necrosis Factor (TNF) Expression by Visit and Timepoint |
4532.72; 29960.41; 54101.30; 1829.87; 10391.60; 1254.29 | — |
| SECONDARY Percentage of Participants With Infection |
2.22; 2.22; 13.33; 8.89; 4.44; 2.22 | — |
| SECONDARY Percentage of Participants With Gastrointestinal Toxicities |
2.22; 2.22; 2.22; 4.44; 2.22; 2.22 | — |
| SECONDARY Percentage of Participants With Hematologic Toxicity |
13.33; 11.11; 8.89; 6.67; 6.67; 6.67 | — |
| SECONDARY Spearman's Rank Correlation Coefficient Between MPA Levels and IMPDH Activity |
0.063; 0.028; 0.034; -0.050 | 0.4505 |
| SECONDARY Spearman's Rank Correlation Coefficient Between IMPDH I Expression and MPA Levels |
0.073; -0.024; 0.037; -0.140 | 0.3892 |
| SECONDARY Spearman's Rank Correlation Coefficient Between IMPDH I Expression and Free Fraction |
0.047; 0.080 | 0.5796 |
| SECONDARY Spearman's Rank Correlation Coefficient Between IMPDH II Expression and MPA Levels |
0.007; 0.073; -0.001; 0.084 | 0.9372 |
| SECONDARY Spearman's Rank Correlation Coefficient Between IMPDH II Expression and Free Fraction |
-0.027; 0.015 | 0.7455 |
| SECONDARY Spearman's Rank Correlation Coefficient Between IMPDH Inhibition and Risk of Acute Rejection |
0.030; 0.083; -0.062; -0.010; -0.121; -0.004 | 0.6847 |
| SECONDARY Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Infection |
0.045; 0.047 | 0.4130 |
| SECONDARY Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Hematologic Toxicity |
-0.116; -0.004 | 0.0316 sig |
| SECONDARY Spearman's Rank Correlation Coefficient Between IMPDH Expression and Risk of Gastrointestinal Toxicity |
0.082; 0.030 | 0.1328 |
| SECONDARY Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Infection |
-0.020; 0.063; 0.030 | 0.7332 |
| SECONDARY Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Hematologic Toxicity |
-0.004; -0.037; -0.038 | 0.9432 |
| SECONDARY Spearman's Rank Correlation Coefficient Between MPA Levels and Risk of Gastrointestinal Toxicity |
0.106; 0.142; 0.187 | 0.0656 |
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
Data sourced from ClinicalTrials.gov (NCT01292226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.