Renoprotection by Pentoxifylline and Angiotensin Receptor Blocker in Chronic Kidney Disease (CKD)
Status:
Unknown status
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial to
investigate the renoprotective efficacy of combined pentoxifylline (PTX) and angiotensin
receptor blockers (valsartan), compared with placebo and valsartan in 700 patients with
Chronic Kidney Disease (CKD) stages 3 and 4. The effect on cardiovascular comorbidity will
also be observed. The observation period will be 3 years. The primary endpoints consists of
doubling of serum creatinine, end stage renal disease (ESRD), and death from any cause. The
secondary endpoints include changes of microalbuminuria or proteinuria, serum and urinary
levels of TNF-a(tumor necrosis factor-alpha ), MCP-1(monocyte chemotactic protein),
TGF-beta1(transforming growth factor ), collagens III (amino terminal peptide of procollagen
III) and IV, and fibronectin, urinary N-acetyl-beta-glucosaminidase, as well as serum
fibrinogen and high-sensitive CRP(C reactive protein), and development of heart failure,
nonfatal myocardial infarction, and stroke or transient ischemic attack.
Phase:
Phase 4
Details
Lead Sponsor:
National Taiwan University Hospital
Collaborators:
Cathay General Hospital Far Eastern Memorial Hospital Mackay Memorial Hospital Shin Kong Wu Ho-Su Memorial Hospital Taipei Medical University Hospital