NCT00155246

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

January 29, 2010

Status Verified

January 1, 2010

Enrollment Period

2 years

First QC Date

September 8, 2005

Last Update Submit

January 27, 2010

Conditions

Chronic Kidney Disease

Keywords

CKD, pentoxifylline

Outcome Measures

Primary Outcomes (1)

  • spot urinary proteinuria between groups

Secondary Outcomes (1)

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

Interventions

pentoxifylline (drug)DRUG

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic kidney disease with serum creatinine 1.3\~6.0 mg/dl

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 39082471DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

PentoxifyllinePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Tun-Jun Tsai, MD, PhD

    National Taiwan University Hosptial

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

July 1, 2004

Primary Completion

July 1, 2006

Study Completion

January 1, 2007

Last Updated

January 29, 2010

Record last verified: 2010-01

Locations

TW(1)