Advagraf/Prograf Conversion Trial

A Randomized, Open Label, Cross Over Study to Examine the Impact of Prograf and Advagraf on Tacrolimus Exposure, Mycophenolic Acid Pharmacokinetics, Renal Allograft Function or Adverse Effects.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01410162

Acronym

SG#153

Enrollment

Registered

2011-08-04

Start date

2010-12-31

Completion date

2014-12-31

Last updated

2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Pancreas Transplant, Renal Transplant

Keywords

Renal, Kidney/Pancreas, Transplant, conversion, bioequivalence, Mycophenolate Acid

Brief summary

Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.

Interventions

DRUGTacrolimus

tacrolimus extended release capsules vs Prograf

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Renal transplant or Renal Pancreas patients who are \> 12 months post transplant * Stable allograft function defined as eGFR \> 30-60ml/min * Renal patients who have a stable tacrolimus trough level of 5-8ng/ml in prior 3 months; Renal pancreas patients who have a stable tacrolimus trough level of 3-10 mg/ml in prior 3 months * Receiving concomitant therapy with mycophenolate mofetil in a dose of 500-1000mg bid or equivalent

Exclusion criteria

* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study. * History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. * Treated rejection within 3 months of randomization. * Increased serum creatinine \> 20% within 3 months of randomization. * Subject is pregnant or breastfeeding * Subject has significant co-morbid disease (eg. Malignancy or uncontrolled infection) or disability (e.g. cognitive deficit) which prevents understanding of, or adherence to, the protocol

Design outcomes

Primary

Measure	Time frame
renal function	baseline to 6 months

Secondary

Measure	Time frame	Description
Bioequivalence of MPA exposure with Advagraf	Baseline, 12 weeks and 24 weeks	Bioequivalence is measured using Pharmacokinetic monitoring of MPA plasma concentrations.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026