Advagraf/Prograf Conversion Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Renal Transplant Kidney Pancreas Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Advagraf

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

tacrolimus extended release capsules vs Prograf

Prograf

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

tacrolimus extended release capsules vs Prograf

Interventions

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Tacrolimus

tacrolimus extended release capsules vs Prograf

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No