Efficacy of Pentoxifylline on Rapidly Progressive Glomerulonephritis

NCT00354198 | Terminated Phase 3

• 1 other identifier: 941008
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

We have recently demonstrated that pentoxifylline (PTX) has the potential to treat severe glomerular inflammation in a rat model of accelerated anti-glomerular basement membrane (GBM) glomerulonephritis. This study aims to investigate the therapeutic effects of combined PTX and conventional immunosuppressive regimens on patients with rapidly progressive glomerulonephritis.

Conditions

Glomerulonephritis

Keywords

rapidly progressive glomerulonephritis; pentoxifylline

Outcome Measures

Primary Outcomes (1)

• initiation of acute dialysis or doubling of serum creatinine levels

  3 months

Secondary Outcomes (1)

• end-stage renal disease (ESRD)

  6 months

Study Arms (2)

corticosteroids

ACTIVE COMPARATOR

\[intravenous pulse methylprednisolone (15 mg/kg/day or a maximum of 1 g/day) x 3 days + oral prednisolone (0.5-1.0 mg/kg/day) for 27 days\] x 3 courses

Drug: corticosteroids

pentoxifylline + corticosteroids

EXPERIMENTAL

\[intravenous pulse methylprednisolone (15 mg/kg/day or a maximum of 1 g/day) x 3 days + oral prednisolone (0.5-1.0 mg/kg/day) for 27 days\] x 3 courses + intravenous infusion of pentoxifylline (0.33-0.66 mg/kg/h) x 7 days + oral pentoxifylline (400-800 mg/day) from days 8 to 90

Drug: pentoxifylline; Drug: corticosteroids

Interventions

pentoxifylline DRUG

intravenous pentoxifylline (0.33-0.66 mg/kg/h from days 1 to 7) followed by oral pentoxifylline 400-800 mg/day (from days 8-90). The dose of intravenous pentoxifylline will be determined by estimated GFR, patients whose GFRs are 30-59 ml/min/1.73 m2 will be given 0.66 mg/kg/h, and those below 30 ml/min/1.73 m2 will be given 0.33 mg/kg/h. The oral dose of pentoxifylline will also be determined by estimated GFR. Patients whose estimated GFRs are between 30-59 ml/min/1.73 m2 will be given 800 mg/day, and those below 30 ml/min/1.73 m2 will be given 400 mg/day.

Also known as: Trental

pentoxifylline + corticosteroids

corticosteroids DRUG

intravenous methylprednisolone (15 mg/kg/day or a maximum of 1 g/day) x 3 days + oral prednisolone (0.5-1.0 mg/kg/day) for 27 days\] x 3 courses

Also known as: Solu-medrol, Predonin

corticosteroids; pentoxifylline + corticosteroids

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• biopsied-proved crescentic glomerulonephritis, with rapidly progressive renal failure

You may not qualify if:

• Anti-GBM disease, Dialysis-dependency or pulmonary hemorrhage, History of allergy to pentoxifylline, Females are nursing or pregnant, Congestive heart failure, 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 or diabetes, Liver cirrhosis or hepatic dysfunction as defined by liver enzymes \> 2 times the upper limit of the normal range, Biliary obstructive disorders, Active malignancy or infection

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Glomerulonephritis

Interventions

Pentoxifylline; Adrenal Cortex Hormones; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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: August 1, 2009
• Study Completion: June 1, 2010
• Last Updated: November 14, 2012

Record last verified: 2012-10

Locations

TW (1)