Phase 2
Completed N=70
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
Source: ClinicalTrials.gov NCT00282568 ↗Enrolled (actual)
70
Serious AEs
58.2%
Results posted
Sep 2013
Primary outcomePrimary: Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus — 215.1; 206.6; 200.7; 197.6 ng*hr/mL
Summary
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) for Tacrolimus |
215.1; 206.6; 200.7; 197.6 | — |
| PRIMARY Maximum Observed Concentration (Cmax) of Tacrolimus |
17.2; 16.0; 14.3; 14.2 | — |
| PRIMARY Minimum Concentration of Tacrolimus (Cmin) |
6.96; 6.73; 6.08; 5.83 | — |
| PRIMARY Time to Maximum Observed Concentration of Tacrolimus (Tmax) |
1.9; 2.0; 3.1; 2.7 | — |
| PRIMARY Patient Survival |
95.45 | — |
| PRIMARY Graft Survival |
86.36 | — |
| SECONDARY Percentage of Participants With Biopsy-confirmed Acute Rejection |
10.61 | — |
| SECONDARY Change From Baseline in Serum Creatinine |
1.37; 0.09; 0.57 | — |
| SECONDARY Change From Baseline in Creatinine Clearance |
62.29; -2.32; -5.41 | — |
| SECONDARY Time to Event for Patient Non Survival |
1754.00 | — |
| SECONDARY Time to Event for Graft Non Survival |
1526.00 | — |
| SECONDARY Time to First Biopsy-confirmed Acute Rejection |
727.00 | — |
| SECONDARY Grade of Biopsy-confirmed Acute Rejection Episodes |
3; 1; 2; 1; 0 | — |
| SECONDARY Number of Participants Receiving Anti-lymphocyte Antibody Therapy for Acute Rejection |
4 | — |
| SECONDARY Number of Participants With Multiple Rejection Episodes |
2 | — |
| SECONDARY Number of Participants With Clinically Treated Acute Rejection Episodes |
7 | — |
| SECONDARY Number of Participants With Chronic Rejection |
— | — |
| SECONDARY Number of Participants With Treatment Failure |
— | — |
| SECONDARY Primary Reason for Graft Loss |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants Returning to Permanent Dialysis |
3 | — |
| SECONDARY Safety as Assessed by Adverse Events, Laboratory Parameters and Vital Signs |
66; 39; 16; 29; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is currently receiving Prograf ® based immunosuppressive therapy for kidney transplantation.
- Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable
Exclusion Criteria
- Patient has previously received an organ transplant other than a kidney
- Patient is currently receiving sirolimus immunosuppression therapy.
Data sourced from ClinicalTrials.gov (NCT00282568). 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.