NCT00354731

Brief Summary

We aim to investigate (1) the effects of combined pentoxifylline and corticosteroids, compared to that of corticosteroids, on patients with primary nephrotic syndrome; and if possible (2) the effects of pentoxifylline monotherapy on patients with primary nephrotic syndrome not suitable for or intolerant of standard corticosteroid therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2006

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 14, 2012

Status Verified

October 1, 2012

Enrollment Period

4.4 years

First QC Date

July 18, 2006

Last Update Submit

November 12, 2012

Conditions

Nephrotic Syndrome

Keywords

nephrotic syndrome, pentoxifylline, corticosteroid

Outcome Measures

Primary Outcomes (1)

  • changes from baseline in urinary protein excretion

    18 months

Secondary Outcomes (1)

  • change from baseline in creatinine and estimated GFR

    18 months

Other Outcomes (1)

  • Urinary nephrin, TNF-alpha and MCP-1

    12 months

Study Arms (2)

corticosteroid

ACTIVE COMPARATOR

Oral prednisolone (1 mg/kg/day) x 3 M, followed by gradual tapering (0.5 mg/kg/day at 6 M, 0.25 mg/day at 12 M, and discontinued at 18 M

Drug: Corticosteroid

Pentoxifylline + corticosteroid

EXPERIMENTAL

Oral pentoxifylline 1,200 mg/day (for estimated GFR ≧60 ml/min) or 800 mg/day (estimated GFR 59-30 ml/min) x 6 months, followed by stepwise reduction (800 mg/day x 6 M, 400 mg/day x 6 M and discontinued at 18 M + oral prednisolone (1 mg/kg/day) x 3 M, followed by gradual tapering (0.5 mg/kg/day at 6 M, 0.25 mg/day at 12 M, and discontinued at 18 M

Drug: pentoxifyllineDrug: Corticosteroid

Interventions

pentoxifyllineDRUG

Oral pentoxifylline 1,200 mg/day (for estimated GFR ≧60 ml/min) or 800 mg/day (estimated GFR 59-30 ml/min) x 6 months, followed by stepwise reduction (800 mg/day x 6 M, 400 mg/day x 6 M and discontinued at 18 M

Also known as: Trental
Pentoxifylline + corticosteroid
CorticosteroidDRUG

Oral prednisolone (1 mg/kg/day) x 3 M, followed by gradual tapering (0.5 mg/kg/day at 6 M, 0.25 mg/day at 12 M, and discontinued at 18 M

Also known as: Predonin
Pentoxifylline + corticosteroidcorticosteroid

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • biopsied-proved primary glomerular diseases, and nephrotic syndrome

You may not qualify if:

  • History of allergy to pentoxifylline, Females are nursing or pregnant, 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, Uncontrolled hypertension with systolic blood pressure \> 200 mmHg and/or diastolic blood pressure \> 110 mmHg, Liver cirrhosis, Biliary obstructive disorders, Active malignancy or infection, Uncontrolled diabetes mellitus, GFR ≦ 30 ml/min/1.73 m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

PentoxifyllineAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Yung-Ming Chen, M.D.

    NTUH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2006

First Posted

July 20, 2006

Study Start

August 1, 2006

Primary Completion

January 1, 2011

Study Completion

April 1, 2011

Last Updated

November 14, 2012

Record last verified: 2012-10

Locations

TW(1)