NCT01102218|TerminatedPhase 2ResultsDMC

Study Stopped

Lack of statistical difference between both arms of the trial.

A Safety Study of Pentoxifylline for the Treatment of Anemia

A Randomized Multi-Center Study to Determine the Safety and Efficacy of Erythropoietin Plus Pentoxifylline Versus Erythropoietin Alone for the Treatment of Anemia in Subjects With End Stage Renal Disease on Maintenance Hemodialysis

Fresenius Medical Care North America ClinicalTrials.gov

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1 other identifier

2010-01

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredApr 2010

StartedAug 2010

CompletionJan 2012

Brief Summary

Chronic kidney disease (CKD) patients have increased levels of inflammation and oxidative stress, which in turn contribute to anemia and cardiovascular disease. Pentoxifylline is known to have anti-inflammatory and anti-oxidant properties, and has shown promise in improving the treatment of patients with anemia. This study will examine the use of pentoxifylline for the treatment of anemia in chronic kidney disease.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Aug 2010

Shorter than P25 for phase_2

Geographic Reach

1 country

10 active sites

Status

terminated

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

1.4 years study duration

First Submitted

Initial submission to the registry

April 9, 2010

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed

4 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed

3 months until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed

Last Updated

March 28, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

April 9, 2010

Results QC Date

January 18, 2012

Last Update Submit

March 26, 2012

Conditions

End Stage Renal Disease

Keywords

Anemia, ESRD

Outcome Measures

Primary Outcomes (1)

Change in Erythropoietin Dose
Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.
Baseline and 6 months

Secondary Outcomes (2)

Examine the EPO Resistance Index (Erythropoietin Dose/kg/Week/Hgb) or ERI Over Time
6 months
Observe Changes in Markers of Inflammation Including But Not Limited to TNF-α and IL-6
6 months

Study Arms (2)

erythropoietin plus pentoxifylline

EXPERIMENTAL

Drug: ErythropoietinDrug: Pentoxifylline

erythropoietin alone

ACTIVE COMPARATOR

Drug: Erythropoietin

Interventions

ErythropoietinDRUG

Standard of Care

erythropoietin plus pentoxifylline

PentoxifyllineDRUG

400 mg qd po for 6 months

Also known as: brand name is Trental

erythropoietin plus pentoxifylline

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, aged ≥18 years;
Able to comply with the study procedures and medication;
Written informed consent given;
On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to screening;
Subject must have been on a stable (\< 25% change) erythropoietin dose with an average of ≥ 15,000 and \<55,000 units/week of treatment for ≥ 14 days prior to screening visit;
Two hemoglobin measurements must meet the following criteria: (1) Taken ≥ 2 weeks apart; (2) Between 10 and 12 g/dL, inclusive; (3) Within 1 g/dL of each other; and (4) Occurred within 30 days prior to screening visit;
If subject is a female and of childbearing potential (pre-menopausal and not surgically sterile), subject is willing to use an effective contraceptive method throughout study, which includes abstinence, barrier methods, hormones, or IUDs;
Life expectancy of 12 months or greater;
Most recent single pool Kt/V ≥1.2, taken within 45 days prior to screening visit;
Stable nutrition status with all albumin levels ≥ 3.0 g/dL within the 30 days prior to screening visit.

You may not qualify if:

Participation in any clinical trial using an investigational product or device during the 30 days preceding the Screening Visit;
Currently undergoing nocturnal hemodialysis;
A significant history of alcohol, drug or solvent abuse in the opinion of the investigator;
Serum iPTH \> 800 pg/mL within 90 days prior to screening visit;
Dysrhythmia or severe cardiac disease: CHF Class III-IV; unstable cardiovascular diagnosis (for example MI, CABG, PTCA, CVA, and TIA) within 90 days prior to screening visit;
Significant concurrent liver disorder \[Aspartate transaminase (AST) or alanine transaminase (ALT) values \> 3 times upper limit of normal (ULN) within 30 days prior to screening\];
Platelet count \< 130x109 within 30 days prior to screening visit or on the day of the screening visit;
Known hypersensitivity to, or intolerance of, Pentoxifylline or other methylxanthines, such as caffeine, theophylline or theobromine;
Currently taking pentoxifylline, warfarin, theophylline, aminophylline, dyphylline, or oxtriphylline;
Absolute or functional iron deficiency \[transferrin saturation (TSAT) \<20%\] within 45 days prior to screening;
Recent or severe hemorrhage per PI discretion;
Significant bleeding episode or prolonged bleeding from dialysis access per PI judgment within the 3 months prior to screening;
Melatonin treatment, androgen therapy or blood transfusion within 30 days prior to screening;
Vitamin C therapy at dose greater than 100 mg/day or at a dose which has changed within the last 3 months;
Current active cancer (excluding basal cell carcinoma of the skin);
+8 more criteria

Contact the study team to confirm eligibility.