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Efficacy of Pentoxifylline on Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
pentoxifylline (drug)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD, pentoxifylline

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Chronic kidney disease with serum creatinine 1.3~6.0 mg/dl Exclusion Criteria: History of allergy to pentoxifylline Females are nursing or pregnant Obstructive uropathy Unable to stop chronic immunosuppressive therapy, NSAID Congestive heart failure (New York Heart Association functional class III or IV) Unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, within the past 6 months prior to signing the informed consent form Cerebral hemorrhage within the past 6 months prior to signing the informed consent form Retinal hemorrhage within the past 6 months prior to signing the informed consent form Known or suspected secondary hypertension (e.g., primary aldosteronism, renovascular hypertension, pheochromocytoma) Severe uncontrolled hypertension with SBP > 220 mmHg and/or DBP > 115 mmHg Hepatic dysfunction as defined by the following laboratory parameters: ALT or AST > 2 times the upper limit of the normal range Biliary obstructive disorders (e.g. cholestasis) Active malignancy

Sites / Locations

  • National Taiwan University Hospital

Outcomes

Primary Outcome Measures

spot urinary proteinuria between groups

Secondary Outcome Measures

estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups.

Full Information

First Posted
September 8, 2005
Last Updated
January 27, 2010
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00155246
Brief Title
Efficacy of Pentoxifylline on Chronic Kidney Disease
Official Title
Phase 4 Study of the Efficacy of Pentoxifylline in Patients With Chronic Kidney Disease Receiving Angiotensin Receptor Blockade
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To study whether pentoxifylline has additive renoprotective effect in patients taking ARB
Detailed Description
In patients with CKD and serum creatinine 1.3~6.0 md/gl, having taken losartan 100 mg/day for at least 3 months, with stable renal function, will be recruited to a randomized open-label trial. Patients taking pentoxifylline or not will be compared for their spot urinary proteinuria, estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups in a 2-year study. Add-on pentoxifylline in control group in the same dose as in treat group will be performed to observe the renoprotective effect if any protective potential is demonstrated in the end of maintenance 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
CKD, pentoxifylline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pentoxifylline (drug)
Primary Outcome Measure Information:
Title
spot urinary proteinuria between groups
Secondary Outcome Measure Information:
Title
estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic kidney disease with serum creatinine 1.3~6.0 mg/dl Exclusion Criteria: History of allergy to pentoxifylline Females are nursing or pregnant Obstructive uropathy Unable to stop chronic immunosuppressive therapy, NSAID Congestive heart failure (New York Heart Association functional class III or IV) Unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, within the past 6 months prior to signing the informed consent form Cerebral hemorrhage within the past 6 months prior to signing the informed consent form Retinal hemorrhage within the past 6 months prior to signing the informed consent form Known or suspected secondary hypertension (e.g., primary aldosteronism, renovascular hypertension, pheochromocytoma) Severe uncontrolled hypertension with SBP > 220 mmHg and/or DBP > 115 mmHg Hepatic dysfunction as defined by the following laboratory parameters: ALT or AST > 2 times the upper limit of the normal range Biliary obstructive disorders (e.g. cholestasis) Active malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tun-Jun Tsai, MD, PhD
Organizational Affiliation
National Taiwan University Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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Efficacy of Pentoxifylline on Chronic Kidney Disease

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