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Incidence of Non Adherence to Treatment With Once-daily Formulation of Tacrolimus (Advagraf)

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ClinicalTrials.gov Identifier: NCT02805842
Recruitment Status : Unknown
Verified July 2016 by Alexander yussim, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2016
Last Update Posted : July 12, 2016
Sponsor:
Collaborators:
Astellas Pharma Inc
Teva Pharma
Information provided by (Responsible Party):
Alexander yussim, Rabin Medical Center

Brief Summary:

Aim The primary objective of this study is to compare medication adherence with medical therapy in patients receiving once-daily versus twice-daily tacrolimus regimens.

Participants 60 adult renal transplant patients randomized 1:2 into twice-daily and once-daily tacrolimus groups

Outcomes The primary outcome will be medication adherence to the once-daily and twice-daily regimens, measured in terms of implementation. Secondary outcomes will include graft and patient survival, renal function and adverse events. Follow up - 12 months


Condition or disease Intervention/treatment Phase
Medication Adherence Drug: Tacrolimus BID Drug: Advagraf QD Phase 3

Detailed Description:

Following randomization (Day 0), 60 kidney transplant recipients of deceased or live kidneys will be randomized 1:2 into control and study- experimental arm. In control arm, named Tacrolimus BID arm, tacrolimus will be administered unchanged twice daily, morning and evening, while in study--experimental group named Tacrolimus QD- Advagraf, the Advagraf tacrolimus formulation will be administered once daily in the morning. In both groups doses will be adjusted to maintain tacrolimus trough levels at 10-12 ng/mL (days 1-28), 8-10 ng/mL (days 29-168) and 6-8 ng/mL thereafter for both treatment arms.

Adjunct immunosuppression. Per-protocol rejection prophylaxis: All patients will receive Basiliximab induction at 20mg/bw on days 0 and 4. Methylprednisolone will be administered as intravenous bolus doses of 500 mg , 250 mg and 125 mg perioperatively, on days 0,1 and 2. Thereafter oral prednisone will be given: 20 mg/day (days 2-14), 15 mg/day (days 15-30), 10 mg/day (days 30-45), 7.5 mg/day (days 45-60) and 5 mg/day thereafter. MMF (2 g BID) will be started preoperatively, and reduced to 500 mg three times daily after 14-30 days.

Rejection treatment: First-line acute rejection (AR) therapy with corticosteroids will be administered at the dose of 500 mg/day for 3 days. Mono- and/or polyclonal antibodies could be used as therapy for corticosteroid-resistant AR. First-line antibody therapy will be permitted only if biopsy indicate a severe vascular rejection (Banff IIB or III).

Prophylactic treatment:

Prophylactic antiviral treatment with oral ganciclovir 450 mg/day, and PCP prevention with 400 mg Sulfamethoxazole and 80 mg of Trimethoprim/day will be given to all patients on days 1-90.

Endpoints.

The primary endpoint:

• adherence to the Tacrolimus administration defined as self-reported number of missed drug ingestions scored in Morisky Medical Adherence Assessment questionnaire

Secondary endpoints:

• efficacy failure defined as biopsy proven rejection, renal function, incidence of adverse events (AEs) and graft loss or death at the end of the analysis period

Statistical analysis The data collected will be analyzed with Fisher's exact test, Wilcoxon' matched pair test and Kaplan-Meier's test

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Incidence of Non Adherence to Treatment With Once-daily Formulation of Tacrolimus (ADVAGRAF) in Kidney Transplant Recipients
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Active Comparator: Tacrolimus BID
20 patients receiving twice daily (BID) Tacrolimus
Drug: Tacrolimus BID
Administration of Tacrolimus BID
Other Name: Prograf, Tacrocell

Active Comparator: Advagraf QD
40 patients randomized to receive once daily (QD) Advagraf
Drug: Advagraf QD
administration of Advagraf QD
Other Name: Advagraf




Primary Outcome Measures :
  1. Morisky Medical Adherence Assessment questionnaire [ Time Frame: 2 years ]
    adherence to the Tacrolimus QD administration defined as self-reported number 9on scale from 1-8) of missed drug ingestions scored in Morisky Medical Adherence Assessment questionnaire


Secondary Outcome Measures :
  1. graft and patient survival [ Time Frame: 2 years ]
    % of patients and grafts alive after 1st and 2nd year of study

  2. gfr [ Time Frame: 2 years ]
    gfr - glomerular filtration rate - a measure of renal function, in ml/min/1.73m2

  3. adverse events [ Time Frame: 2years ]
    percentage of patients with complications



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age: 18 Years to 60 Years
  • Gender: both
  • Patients willing and able to participate in this study
  • Patients who signed the informed consent form
  • Patients who can visit the center based on the study schedule in the protocol

Exclusion Criteria

  • Patients who had previously received a kidney or another organ
  • Patients, having positive lymphocyte cross-match
  • Patients with PRA >50%
  • Patients, who underwent desensitization
  • Patients, who were diagnosed with cancer in the last five years
  • Patients, who themselves or their donors have positive HIV, HBsAg, or anti-HCV test results
  • Patients, who were treated with other investigated drugs within 30 days from their study enrollment
  • Patients, who are planning to be pregnant, or who are pregnant or breastfeeding and who are not planning to use any contraceptive method during the study period.
  • Patients who were addicted to drugs/alcohol within six months of their study enrollment
  • Patients, who have a mental illness that makes appropriate communication with them impossible

Information from the National Library of Medicine

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): NCT02805842


Contacts
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Contact: Eytan Mor, MD 97239376472 emor@clalit.org.il
Contact: Alex Yussim, MD 97239376479 ayussim@clalit.org.il

Locations
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Israel
Rabin Med Ctr
Petach Tikva, Israel, 4100
Sponsors and Collaborators
Rabin Medical Center
Astellas Pharma Inc
Teva Pharma
Investigators
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Study Director: Eyan Mor, MD Rabin Med CTR
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Responsible Party: Alexander yussim, Director transplantation research unit, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02805842    
Other Study ID Numbers: 0076-16 RMC
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Alexander yussim, Rabin Medical Center:
non adherence
Tacrolimus
Advagraf
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action