Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT00913393
Status:
TERMINATED
Last Update Posted:
2019-02-22
First Post:
2009-06-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of FibroGen (FG)-3019 in Subjects With Type 2 Diabetes Mellitus and Kidney Disease on ACEi and/or ARB Therapy
Sponsor:
FibroGen
Organization:
Study Overview
Official Title:
A Phase 2 Randomized, Double-blind, Placebo-controlled Study of FG-3019 in Subjects With Type 2 Diabetes Mellitus (DM) and Persistent Proteinuria on Background Angiotensin Converting Enzyme Inhibitor (ACEi) and/or Angiotensin II Receptor Blockade (ARB) Therapy
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated early for business purposes and as a result of a strategic decision to shift focus to another indication.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of FG-3019 on diabetic kidney disease or diabetic nephropathy.
Detailed Description:
The primary objective of this study is to assess the effect of FG-3019 on proteinuria as assessed by urinary albumin/creatinine ratio (ACR).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: