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Efficacy of Pentoxifylline on Chronic Kidney Disease

NCT ID: NCT00155246

Last Updated: 2010-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-01-31

Brief Summary

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To study whether pentoxifylline has additive renoprotective effect in patients taking ARB

Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Keywords

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CKD, pentoxifylline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pentoxifylline (drug)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan University Hospital

Principal Investigators

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Tun-Jun Tsai, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hosptial

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Natale P, Mooi PK, Palmer SC, Cross NB, Cooper TE, Webster AC, Masson P, Craig JC, Strippoli GF. Antihypertensive treatment for kidney transplant recipients. Cochrane Database Syst Rev. 2024 Jul 31;7(7):CD003598. doi: 10.1002/14651858.CD003598.pub3.

Reference Type DERIVED
PMID: 39082471 (View on PubMed)

Other Identifiers

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930202

Identifier Type: -

Identifier Source: org_study_id