A Single Centre Physiological Study of Glucose Metabolism Before and After Tacrolimus Withdrawal For Deteriorating Kidney Function In Renal Transplant Recipients - Tacrolimus And Glucose Metabolism In Renal Transplantation (v. 1.1)

• Conditions: Alterations in glucose metabolism secondary to tacrolimus (Prograf), a calcineurin inhibitor, after kidney transplantation.

• Registration Number: EUCTR2010-022075-66-GB
• Lead Sponsor: Cardif and Vale University Local Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-23
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
;
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

• 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

;
• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified