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Phase 4 Study of the Efficacy of Pentoxifylline in Patients With Chronic Kidney Disease Receiving Angiotensin Receptor Blockade


Phase 4
20 Years
70 Years
Not Enrolling
Both
Chronic Kidney Disease

Thank you

Trial Information

Phase 4 Study of the Efficacy of Pentoxifylline in Patients With Chronic Kidney Disease Receiving Angiotensin Receptor Blockade


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

spot urinary proteinuria between groups

Principal Investigator

Tun-Jun Tsai, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hosptial

Authority:

Taiwan: Department of Health

Study ID:

930202

NCT ID:

NCT00155246

Start Date:

July 2004

Completion Date:

January 2007

Related Keywords:

  • Chronic Kidney Disease
  • CKD, pentoxifylline
  • Kidney Diseases
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic

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