NCT01334333

Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients

Completed Phase 4 Last updated 17 May 2018

What this trial tests

Phase 4 trial testing Tacrolimus - Prograf® twice daily formulation in Renal Disease in 46 participants. Completed in 1 March 2018.

Timeline

11 November 2011

Primary endpoint
30 October 2014

1 March 2018

Quick facts

Lead sponsor	University of British Columbia
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	46
Start date	11 November 2011
Primary completion	30 October 2014
Estimated completion	1 March 2018
Sites	1 location across Canada

Drugs / interventions tested

• Tacrolimus - Prograf® twice daily formulation — full drug profile →
• Tacrolimus - Advagraf® once daily formulation — full drug profile →

Conditions studied

• Renal Disease — all drugs for Renal Disease →
• Renal Transplant — all drugs for Renal Transplant →

Sponsor

University of British Columbia

Who can join

19 and older, any sex, with Renal Disease or Renal Transplant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A critical aspect of real-world functioning following kidney transplantation involves how adherent individuals are to their medication regimens. Regardless of the possible dangers of failing to adhere to anti-rejection medications, such as increased graft rejection, studies have reported rates of non-adherence at almost 50% following renal transplant.

The Cognitive Aging Laboratory under the direction of Dr. Wendy Thornton, at Simon Fraser University, has previously identified relationships between several potentially important cognitive and psychosocial variables, and self-reported medication adherence in renal transplant recipients, including depressive symptoms, as well as everyday and traditional cognitive functioning \[4\]. The possibility that changes in dosing regimens for a given medication may have an additional impact on medication adherence presents an important issue worth further exploration.

The current study will allow for more thorough delineation of the roles of psychosocial and cognitive predictors of adherence with state-of-the-art monitoring techniques. In addition, the investigators will assess whether different dosing formulations of tacrolimus impact adherence behaviors in renal transplant recipients.

The proposed research has two primary aims to examine:

1. To examine the role of cognitive and psychosocial variables in predicting medication adherence in renal transplant recipients.
2. To examine whether different formulations of tacrolimus (once per day dosing versus twice per day dosing) will impact medication adherence in renal transplant recipients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of Once- Versus Twice-Daily Tacrolimus Dosing on Medication Adherence in Stable Renal Transplant Recipients: A Canadian Single-Center Randomized Controlled Trial.
   Paterson TSE, Demian M, Shapiro RJ, Loken Thornton W. · · 2019 · cited 8× · PMID 31452902 · DOI 10.1177/2054358119867993