Metabolic and Renal Effects of Rosiglitazone in Kidney Transplant
Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
Participant gender:
Summary
Abnormalities in glucidic and lipidic metabolism are common features in renal transplant
patients on chronic immunossupression with steroids and calcineurin inhibitors. In kidney
transplant patients with chronic rejection these abnormalities cluster with renal and
cardiovascular risk factors and altogether may sustain premature graft loss and may increase
the risk of cardiovascular morbidity and mortality. Thiozolidinediones are a new class of
oral antidiabetic agents that may increase insulin sensitivity improving the glucose
tolerance and dyslipidemia. Moreover, rosiglitazone -one of these drugs- has been reported to
decrease blood pressure and albuminuria in subjects with type 2 diabetes and nephropathy.
Recent finding that glitazones ameliorate the glucidic and lipidic profile induced by steroid
treatment in healthy subjects, provided a further rationale to evaluate the metabolic and
renal effects of glitazones in renal transplant patients on chronic steroid therapy. Thus, we
designed and organized a pilot study to assess the short-term risk/benefit profile of
rosiglitazone in renal transplant patients with chronic rejection. Ten patients will have a
basal evaluation of insulin sensitivity, glucose tolerance,lipid profile, renal hemodynamic
and albuminuria. These evaluations will be repeated at the end of the treatment (4 months of
therapy with rosiglitazone 8 mg/day) period and 2 months after treatment withdrawal.
Phase:
Phase 2
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research