Renoprotection by Pentoxifylline and Angiotensin Receptor Blocker in Chronic Kidney Disease (CKD)

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.

Conditions

• Chronic Renal Failure

Interventions

DRUG

ARB

Angiotensin II receptor antagonists ,these medicines have names that end in "sartan".For examples:losartan,candesartan,irbesartan,olmesartan,telmisartan,valsartan

DRUG

Pentoxifylline

This medication is used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease)

DRUG

Placebo (for Pentoxifylline)

Sugar pill manufactured to mimic Pentoxifylline 400mg tablet

Sponsors & Collaborators

• Far Eastern Memorial Hospital

  collaborator OTHER

• Mackay Memorial Hospital

  collaborator OTHER

• Taipei Medical University Hospital

  collaborator OTHER

• Shin Kong Wu Ho-Su Memorial Hospital

  collaborator OTHER

• Cathay General Hospital

  collaborator OTHER

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Yung-Ming Chen, M.D.; PhD · National Taiwan University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• Taiwan

Study Locations