A Phase 4 interventional study of Once Daily Tacrolimus and Twice Daily Tacrolimus in Immunosuppression, Cardiovascular Diseases and Kidney Transplantation, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by University of Saskatchewan · Phase 4, Interventional, and Supportive care
Current standard prophylactic immunosuppression in renal transplantation includes tacrolimus, a calcineurin inhibitor, dosed twice daily. In Canada, oral tacrolimus has been available as a twice daily formulation marketed as Prograf® since 1997. It has recently become available in an extended release formulation called Advagraf®, which is dosed once daily. Advagraf® has been demonstrated to be therapeutically equivalent to Prograf® in the renal transplant maintenance population, and as a result it has been is approved as an alternative to the twice daily formulation in these patients. There is an evolving and expanding positive clinical experience with Advagraf® in kidney transplantation and it has shown to be preferred by many patients, due to the diminished dosing frequency. In clinical trials, Advagraf® has been shown to have other potential benefits over Prograf® such as less inter and intra-patient variability, improved cardiovascular profiles, and improved kidney function. Compared to Prograf®, Advagraf® also has a lower Cmin or 'trough' concentration as well as a lower Cmax or 'peak' concentration. The purpose of this study is to convert stabilized renal transplant patients currently receiving Prograf® to Advagraf®, to investigate these potential therapeutic benefits.
The Framingham Risk Score and the Reynold's Risk Score are currently recommended by the Canadian Cardiovascular Society (CCS) to predict 10-year cardiovascular risk in the general population. Surrogate markers are widely used in clinical trials to shorten follow-up durations. In this study, the investigators will use the Framingham Risk Score and Reynold's Risk Score to quantify changes in estimated cardiovascular risk. The investigators also intend to examine novel inflammatory markers to investigate cardiovascular risk.
The investigators hypothesize that the more consistent drug exposure and lower Cmax noted with Advagraf® will decrease Framingham Risk Score, Reynolds Risk score as well as markers of inflammation in kidney transplant recipients.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 36 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment Arm - Subjects are switched from the tacrolimus twice daily (Prograf®) to the once daily formulation (Advagraf®) to maintain a trough tacrolimus level of 5-8.
Drug: Once Daily Tacrolimus
Control Arm - Subjects are kept on Prograf® which is the Twice Daily Tacrolimus
Drug: Twice Daily Tacrolimus
Subjects switched from the tacrolimus twice daily (Prograf®) to the once daily formulation (Advagraf®) to maintain a trough tacrolimus level of 5-8.
Also known as: Advagraf®
Subjects are kept on Prograf® which is the Twice Daily Tacrolimus
Also known as: Prograf®
Change in the Framingham risk scores and change in the Reynolds Risk Score.
Time frame: Visit 1, Visit 3 (12 months)
Comparison in GFR between the two groups.
Time frame: Visit 1, Visit 3 (12 months)
Effect of therapy on CV biomarkers, insulin resistance and lipid profile.
CV biomarkers will be assessed by luminex and insulin resistance and lipid profile will be assessed by the Metabolic Syndrome
Time frame: Visit 1, Visit 3 (12 months)
To look at change in the glomerular filtration rate (GFR) over the duration of the study.
Time frame: Vist 1, Visit 3 (12 months)
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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University of Saskatchewan