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Rosiglitazone in Albuminuric Kidney Transplant Recipients
NCT00309309Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2005
- Countries
- 1
- Sponsor
- Mario Negri Institute for Pharmacological Research
- Modality
- Small Molecules
- Drugs
- rosiglitazone
- Conditions
- chronic allograft dysfunction (CAD)
01
Overview
Phase 2, open-label, single-arm trial of rosiglitazone in chronic allograft dysfunction (CAD), sponsored by Mario Negri Institute for Pharmacological Research. Primary endpoints: Insulin sensitivity at 6 months, Blood pressure at 6 months and 1 more. Started Apr 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Rosiglitazone
Patients receive Rosiglitazone for 4 months
03
Who it enrols
Adult kidney transplant recipients (>= 6 months post-transplant) with chronic allograft dysfunction, stable creatinine <= 3mg/dl, and albuminuria >= 20µg/min, on stable RAS inhibitors. Excludes patients on FK506, with overt diabetes, heart failure, or liver disease.
04
Endpoints
Primary
Insulin sensitivity
Blood pressure
Albumin urinary excretion
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