Once Daily Immunosuppression Regimen
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|ClinicalTrials.gov Identifier: NCT03555448|
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant; Complications||Drug: Once daily immunosuppression regimen Drug: Twice daily immunosuppression regimen||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Once a Day Immunosuppression Regimen: Outcomes and Compliance|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Once daily regimen
Once daily medication regimen (Envarsus and azathioprine)
Drug: Once daily immunosuppression regimen
Intervention focuses on the type of regimen, in this case the intervention arm will receive a once daily regimen for immunosuppression compared to the twice daily regimen.
Active Comparator: Twice daily regimen
Twice daily medication regimen (Tacrolimus and mycophenolic acid)
Drug: Twice daily immunosuppression regimen
This is the arm which we are designating the standard, which will be the comparison to the active drug arm.
- Change in Compliance and tolerability of medication regimen at 3 and 12 months [ Time Frame: 3 months and 12 months post transplant ]BAASIS Survey
- Change in Self-recorded Compliance and tolerability of medication regimen at 3 and 12 months [ Time Frame: 3 months and 12 months post transplant ]Pill Manager (personal medication record keeping for those who participants who choose to use this method of recording their self-administered medication)
- Composite endpoint measurement [ Time Frame: 12 months ]Incidence of Biopsy proven Acute Rejection, graft loss, death, Lost to follow-up at 12 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555448
|Contact: Rowena Delos Santos, MDfirstname.lastname@example.org|
|Contact: Tarek Alhamad, MDemail@example.com|
|Principal Investigator:||Rowena Delos Santos||Washington University School of Medicine|