NCT01797341

Brief Summary

The present study is aimed at evaluating the impact of a switch from Prograf to Advagraf on renal function, trough tacrolimus levels, drug-related adverse effects and adherence in stable recipients of kidney-pancreas transplants. MPA pharmacokinetics will also be evaluated. The results of this study have the potential to change current practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 18, 2014

Status Verified

July 1, 2014

Enrollment Period

8 months

First QC Date

February 11, 2013

Last Update Submit

September 17, 2014

Conditions

Kidney-Pancreas Transplantation

Keywords

Renal TransplantationKidney transplantationPancreas TransplantationTacrolimusAdvagrafPrografDrug Adherence

Outcome Measures

Primary Outcomes (3)

  • Tacrolimus trough levels

    Serum trough levels

    prior to conversion and 12 weeks post-conversion

  • Change in Renal Function

    Serum creatinine and urea levels

    prior to conversion and 12 weeks post-conversion

  • Change in Tacrolimus dosage (week 12 compared to week 24)

    week 12 and week 24

Secondary Outcomes (5)

  • Change in Fasting glucose

    prior to conversion and 12 weeks post-conversion

  • Lipid profile

    prior to conversion and 12 weeks post-conversion

  • blood pressure

    prior to conversion and 12 weeks post-conversion

  • Drug Adherence

    assessed at weeks 12 and 24

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability"

    at week 12 and week 24

Study Arms (2)

Prograf arm

EXPERIMENTAL

patients will self-administer tacrolimus in the form of Prograf (twice daily administration. Dosage will be adjusted to maintain trough serum levels of 5-15 μg/ml. Maximum daily dose of 20 mg once per day.

Drug: Tacrolimus

Advagraf Arm

EXPERIMENTAL

patients will self-administer tacrolimus in the form of Advagraf (once daily dosing) Dosage will be adjusted to maintain trough serum levels of 5-15 μg/ml. Maximum daily dose of 20 mg once per day.

Drug: Tacrolimus

Interventions

TacrolimusDRUG
Also known as: Prograf
Prograf arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • recipient of kidney and pancreas transplant
  • aged 18 years or older
  • months or more since time of transplant
  • stable allograft function (creatinine \< 180 µmol/l and eGFR \> 40 ml/min)
  • targeted to a tacrolimus trough level of 5-10 ug/ml that has been stable during the prior 3 mo.

You may not qualify if:

  • episode of acute rejection within 6 months of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Mark S Cattral, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

February 22, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 18, 2014

Record last verified: 2014-07

Locations

CA(1)