Advagraf/Prograf Conversion Trial

Phase 4

Completed

• Conditions: Renal Transplant; Kidney Pancreas Transplant
• Interventions: Drug: Tacrolimus

• Registration Number: NCT01410162
• Lead Sponsor: Norman Muirhead

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-08-03
• Study First Posted: 2011-08-04
• Primary Completion: 2014-02
• Study Completion: 2014-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Advagraf	Tacrolimus	-
Prograf	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
renal function	baseline to 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada