Phase 4
Completed N=23
A Pharmacokinetic Study of CellCept (Mycophenolate Mofetil) Versus Mycophenolate Sodium in Kidney Transplant Patients
Source: ClinicalTrials.gov NCT01033864 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Pre-dose Trough Concentration (C0) — 2.387; 2.944 mg/L — p=0.8055
Summary
This open-label, 2-arm study will compare the pharmacokinetics of CellCept and mycophenolate sodium in kidney transplanted patients on a calcineurininhibitor-free mycophenolic acid-based therapy. On the study day patients will take their prescribed medication (either CellCept or mycophenolate sodium). Blood samples will be drawn directly before and at intervals up to 12 hours after intake of the study medication. Anticipated time on study treatment is 12 hours and target sample size is 24.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-dose Trough Concentration (C0) |
2.387; 2.944 | 0.8055 |
| PRIMARY Dose-Normalized C0 |
2.962; 4.658 | 0.2548 |
| PRIMARY Minimum Plasma Concentration (Cmin) |
1.385; 1.620 | 0.4417 |
| PRIMARY Dose-Normalized Cmin |
1.702; 2.613 | 0.0455 sig |
| PRIMARY Maximum Plasma Concentration (Cmax) |
15.385; 17.827 | 0.2300 |
| PRIMARY Dose-Normalized Cmax (mg/L) |
18.402; 29.996 | 0.0106 sig |
| PRIMARY MPA Area Under the Curve From 0 to 12 Hours (AUC0-12) |
50.36348; 57.06682 | 0.3401 |
| PRIMARY Dose-Normalized MPA AUC0-12 |
61.53862; 94.65765 | 0.0074 sig |
| PRIMARY Percentage of Participants By Time to Maximum Plasma Concentration (Tmax) |
16.7; 0.0; 16.7; 0.0; 16.7; 0.0 | 0.0002 sig |
| SECONDARY Regression Coefficients For Participants Receiving MMF |
2.17192; 0.74031; 1.89323; 2.85923 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >/=18 years of age
- kidney transplantation >/=6 months ago
- on mycophenolic acid-based, calcineurininhibitor-free therapy for >/=3 months, >/=1 month on stable dose
- co-therapy with 5mg prednisone for >/=1 month
Exclusion Criteria
- active gastrointestinal ulcus
- severe diarrhea od gastrointestinal disease
- severe impairment of renal function
- current malignancy
- Lesch-Nyhan- or Kelley-Seegmiller-Syndrome
Data sourced from ClinicalTrials.gov (NCT01033864). 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.