Advagraf/Prograf Conversion Trial (SG#153)

Norman Muirhead

Status and phase

Completed

Phase 4

Conditions

Renal Transplant

Kidney Pancreas Transplant

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01410162

17393 (Other Identifier)

R-10-647

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No 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