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A Double-blind, Proof of Concept Trial of the use of Pegvisomant to Reduce Urinary Albumin excretion in Type 1 and Type 2 Diabetic Patients treated with Angiotensin Convertase Inhibitors/Angiotensin r...

Update Il y a 5 ans
Reference: EUCTR2004-001190-25

A Double-blind, Proof of Concept Trial of the use of Pegvisomant to Reduce Urinary Albumin excretion in Type 1 and Type 2 Diabetic Patients treated with Angiotensin Convertase Inhibitors/Angiotensin receptor blockers, with persistent Albuminuria

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Extract

To establish that Pegvisomant causes a clinically meaningful decrease in urinary albumin creatinine ratio (UACR) beyond that provided by ACEIs and ARBs. A clinically meaningful decrease is defined as either a 30% average decrease in UACR or a significant percentage of subjects (≥70%) showing a 30% decrease in UACR.

Inclusion criteria

  • Diabetic nephropathy DN (Diabetes mellitus (DM) type I and type II with renal manifestations),MedDRA classification code : 10061835, 10045236 and 10045250 (Version 7.0, Level LLT)

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