NCT00285298

Brief Summary

The purpose of the investigators study is to assess the impact of therapy with Pentoxifylline (PTF), a nonspecific phosphodiesterase inhibitor, on kidney function in patients at high-risk for progression to end-stage renal disease. The investigators hypothesize that therapy with Pentoxifylline will slow progression of kidney disease over time.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 29, 2011

Status Verified

September 1, 2009

Enrollment Period

2.2 years

First QC Date

January 31, 2006

Last Update Submit

July 28, 2011

Conditions

Kidney Failure, Chronic

Keywords

proteinuriaKidney failure, chronic

Outcome Measures

Primary Outcomes (1)

  • Rate of decline in estimated glomerular filtration rate over one year

    1 year

Secondary Outcomes (2)

  • 50% reduction in proteinuria

    1 year

  • Change in slope of 1/serum creatinine vs time

    1 year

Study Arms (2)

Pentoxifylline

EXPERIMENTAL
Drug: Pentoxifylline

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PentoxifyllineDRUG
Pentoxifylline
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age or older currently being treated with an ACE-I or ARB and with one of the following conditions:
  • Non-nephrotic range proteinuria (between 1 and 3 grams/day by 24-hr collection), hypertension (blood pressure \>130/80 or current use of antihypertensive drug therapy), and an eGFR of less than or equal to 40 ml/minute but greater than 20 ml/minute.
  • Nephrotic range proteinuria (\>=3 grams/day proteinuria) by 24-hr urine collection, and an eGFR greater than 20 ml/minute

You may not qualify if:

  • Acute renal failure: defined by \>25% decrease in eGFR over one month
  • Pregnancy or currently breast-feeding
  • Current use of cytotoxic drug therapy (cyclophosphamide, cyclosporine, mycophenolate mofetil, prednisone, chlorambucil) or a current indication for, and plan to implement, such therapy.
  • Current use of PTF
  • Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage
  • Current use of theophylline
  • Contraindication to ACE-I or ARB.
  • Fewer than 2 measured serum creatinine values separated by 6 months prior to potential enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Perkins RM, Aboudara MC, Uy AL, Olson SW, Cushner HM, Yuan CM. Effect of pentoxifylline on GFR decline in CKD: a pilot, double-blind, randomized, placebo-controlled trial. Am J Kidney Dis. 2009 Apr;53(4):606-16. doi: 10.1053/j.ajkd.2008.11.026. Epub 2009 Feb 12.

    PMID: 19216016RESULT

  • Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

    PMID: 37916745DERIVED

MeSH Terms

Conditions

Kidney Failure, ChronicProteinuria

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrination DisordersUrological ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Robert M Perkins, MD

    Walter Reed Army Medical Center, Nephrology Service

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 29, 2011

Record last verified: 2009-09