Advagraf/Prograf Conversion Trial

Renal Transplant Clinical Trial

— SG#153  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410162
• Other study ID #: R-10-647
• Secondary ID: 17393
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2011
• Last updated: August 31, 2015
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Pancreas Transplant
• Renal Transplant

Intervention

Drug:
• Tacrolimus
tacrolimus extended release capsules vs Prograf

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Norman Muirhead	Astellas Pharma Canada, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function		baseline to 6 months	Yes
Secondary	Bioequivalence of MPA exposure with Advagraf	Bioequivalence is measured using Pharmacokinetic monitoring of MPA plasma concentrations.	Baseline, 12 weeks and 24 weeks	No