Metabolic and Renal Effects of Rosiglitazone in Kidney Transplant

NCT00309309 | Completed Phase 2

• 1 other identifier: GLITA-TX
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (3)

• Insulin sensitivity (at 0,4,6 months)

• Blood pressure (at 0,4,6 months)

• Albumin urinary excretion (at 0,4,6 months)

Interventions

Rosiglitazone DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age: 18-70 years old
• kidney transplant since at least six months
• serum creatinine ≤ 3mg/dl without dialysis requirement
• serum creatinine changes ≤ + 30 % over the last three months
• overnight urinary albumin excretion rate ≥20µg/min
• well controlled hypertension (systolic/diastolic blood pressure \<150/90 mmHg)
• concomitant treatment with inhibitors of the renin angiotensin system (RAS) since at least six months
• effective contraception
• written informed consent
• legal capacity

You may not qualify if:

• acute graft rejection over the last six months
• immunosuppressive therapy with FK506
• evidence of previous or concomitant liver disease and abnormal liver transaminases over the last six months
• evidence of heart failure (NYHA class II or more) or fluid overload
• overt diabetes or concomitant treatment with oral antidiabetic agents and/or insulin
• specific contraindication to the study drug
• legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Clinical Research Center for Rare Diseases

Ranica, Bergamo, 24020, Italy

Location

MeSH Terms

Interventions

Rosiglitazone

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Norberto Perico, MD

  Mario Negri Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2006
• First Posted: March 31, 2006
• Study Start: April 1, 2005
• Study Completion: July 1, 2007
• Last Updated: July 3, 2007

Record last verified: 2007-07

Locations

IT (1)