Trial · NCT01102218

A Safety Study of Pentoxifylline for the Treatment of Anemia

NCT01102218, Phase 2, Terminated, Fresenius Medical Care North America; results first posted 2012-03-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety Study of Pentoxifylline for the Treatment of Anemia. Trials, record NCT01102218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01102218

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety Study of Pentoxifylline for the Treatment of Anemia
NCT number: NCT01102218
Status: Terminated
Phases: Phase 2
Enrollment: 48 participants, actual
Lead sponsor: Fresenius Medical Care North America
Conditions: End Stage Renal Disease
Interventions: Erythropoietin, Erythropoietin, Pentoxifylline
First posted: 2010-04-13
Last updated: 2012-03-28
Results first posted: 2012-03-26
Limitations and caveats: Release of new FDA guidelines re target Hgb values impacted EPO dosing.

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Erythropoietin Dose	Baseline and 6 months	Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.
Secondary	Examine the EPO Resistance Index (Erythropoietin Dose/kg/Week/Hgb) or ERI Over Time	6 months
Secondary	Observe Changes in Markers of Inflammation Including But Not Limited to TNF-α and IL-6	6 months

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Erythropoietin Dose	Baseline and 6 months	The number of patients for analysis was based on those patient who had completed 6 months of treatment. The analysis was per protocol.	Units EPO	MEAN
SECONDARY	Examine the EPO Resistance Index (Erythropoietin Dose/kg/Week/Hgb) or ERI Over Time	6 months
SECONDARY	Observe Changes in Markers of Inflammation Including But Not Limited to TNF-α and IL-6	6 months

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Erythropoietin Dose	Erythropoietin Plus Pentoxifylline		-8700	Standard Deviation 12586	Units EPO
Change in Erythropoietin Dose	Erythropoietin Alone		-2988	Standard Deviation 10232	Units EPO

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Erythropoietin Plus Pentoxifylline	24
Overall Study	STARTED	Erythropoietin Alone	24
Overall Study	COMPLETED	Erythropoietin Plus Pentoxifylline	13
Overall Study	COMPLETED	Erythropoietin Alone	14
Overall Study	NOT COMPLETED	Erythropoietin Plus Pentoxifylline	11
Overall Study	NOT COMPLETED	Erythropoietin Alone	10

Source ClinicalTrials.gov

Adverse events34

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	GI upset	Gastrointestinal disorders	Erythropoietin Plus Pentoxifylline	6	24	13
other	GI upset	Gastrointestinal disorders	Erythropoietin Alone	6	24	11
other	Infection	Infections and infestations	Erythropoietin Plus Pentoxifylline	5	24	6
other	Infection	Infections and infestations	Erythropoietin Alone	7	24	13
other	Access-related	Vascular disorders	Erythropoietin Plus Pentoxifylline	3	24	7
other	Access-related	Vascular disorders	Erythropoietin Alone	4	24	6
other	Other	General disorders	Erythropoietin Plus Pentoxifylline	2	24	5
other	Other	General disorders	Erythropoietin Alone	3	24	3
other	Pain	General disorders	Erythropoietin Plus Pentoxifylline	4	24	5
other	Pain	General disorders	Erythropoietin Alone	2	24	2

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Erythropoietin Plus Pentoxifylline
Total, all-cause mortality	Erythropoietin Alone
Total, other adverse events	Erythropoietin Plus Pentoxifylline	22	24
Total, other adverse events	Erythropoietin Alone	24	24
Total, serious adverse events	Erythropoietin Plus Pentoxifylline	12	24
Total, serious adverse events	Erythropoietin Alone	12	24

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Erythropoietin Plus Pentoxifylline vs Erythropoietin Alone: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01102218

GET https://conductscience.org/api/trials/v1/NCT01102218/events?page=2

API reference For AI assistants