Alterations in glucose metabolism secondary to tacrolimus (Prograf), a calcineurin inhibitor, after kidney transplantation.
Conditions
Interventions
Trade Name: Prograf
Product Name: Prograf
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Tacrolimus (as monohydrate)
Other descriptive name: Prograf
Concentration unit: mg milligram(s)
Concen
Sponsors
Cardif and Vale University Local Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a. Caucasian kidney transplant recipients who have undergone transplantation more than 12 months ago at the University Hospital of Wales, and currently being treated with a combination of tacrolimus and mycphenolate mofetil/mycophenolic acid. b. Functioning kidney transplant with follow up in the transplant clinic at the University Hospital of Wales. b. Decision by subjects’ own transplant physicians to withdraw tacrolimus c. Fasting plasma glucose less than 7.0 mmol/L Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: a. Caucasian kidney transplant recipients who have undergone transplantation more than 12 months ago at the University Hospital of Wales, and currently being treated with a combination of tacrolimus and mycphenolate mofetil/mycophenolic acid. b. Functioning kidney transplant with follow up in the transplant clinic at the University Hospital of Wales. b. Decision by subjects’ own transplant physicians to withdraw tacrolimus c. Fasting plasma glucose less than 7.0 mmol/L Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Concurrent liver disease • Pregnancy • Unstable graft function with incipient graft failure • History of acute graft rejection in the previous six months • Fasting plasma glucose of more than 7.0 mmol/L • Intolerance to Mycophenolate mofetil or Mycophenolic acid . Previous cytomegalovirus infection ;Exclusion criteria: • Concurrent liver disease • Pregnancy • Unstable graft function with incipient graft failure • History of acute graft rejection in the previous six months • Fasting plasma glucose of more than 7.0 mmol/L • Intolerance to Mycophenolate mofetil or Mycophenolic acid . Previous cytomegalovirus infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change in pancreatic beta islet cell function and change in insulin sensitivity after the withdrawal of tacrolimus in kidney transplant recipients.;Main Objective: Is the toxicity of the antirejection drug tacrolimus (a type of Calcineurin inhibitor - [CNI] used in kidney transplantation) on pancreatic beta cell function and insulin production reversible and does the withdrawal of CNIs improve glucose metabolism in kidney transplant recipients?;Secondary Objective: A secondary objective will be to explore the relationship between the level of kidney function and risk of developing diabetes mellitus in kidney transplant recipients.;Primary end point(s): Change in pancreatic beta islet cell function and change in insulin sensitivity after the withdrawal of tacrolimus in kidney transplant recipients.;Main Objective: Is the toxicity of the antirejection drug tacrolimus (a type of Calcineurin inhibitor - [CNI] used in kidney transplantation) on pancreatic beta cell function and insulin production reversible and does the withdrawal of CNIs improve glucose metabolism in kidney transplant recipients?;Secondary Objective: A secondary objective will be to explore the relationship between the level of kidney function and risk of developing diabetes mellitus in kidney transplant recipients. | — |
Countries
United Kingdom
Contacts
Public Contact; ;
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Outcome results
None listed