Trial Outcomes & Findings for A Safety Study of Pentoxifylline for the Treatment of Anemia (NCT NCT01102218)
NCT ID: NCT01102218
Last Updated: 2012-03-28
Results Overview
Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2012-03-28
Participant Flow
This study was conducted at Fresenius Medical Care North America Dialysis clinics between August 2010 and October 2011.
There was no wash out or run in period for this trial.68 subjects signed informed consent, and 48 subjects were randomized.13 of the 20 screen failures were due to exclusionary lab values, 3 due to excluded medications, and 3 were due to other exclusion criteria, 1 due to unrelated SAE. Zero patients withdrew consent prior to randomization.
Participant milestones
| Measure |
Erythropoietin Plus Pentoxifylline
Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
|
Erythropoietin Alone
Standard of care prescribed erythropoietin dose.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety Study of Pentoxifylline for the Treatment of Anemia
Baseline characteristics by cohort
| Measure |
Erythropoietin Plus Pentoxifylline
n=24 Participants
Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
|
Erythropoietin Alone
n=24 Participants
Standard of care prescribed erythropoietin dose.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age Continuous
|
56 years
STANDARD_DEVIATION 12 • n=5 Participants
|
57 years
STANDARD_DEVIATION 14 • n=7 Participants
|
56 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The number of patients for analysis was based on those patient who had completed 6 months of treatment. The analysis was per protocol.
Erythropoietin dose is amount needed to maintain a hemoglobin between 11 and 12 mg/dL.
Outcome measures
| Measure |
Erythropoietin Plus Pentoxifylline
n=9 Participants
Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
|
Erythropoietin Alone
n=8 Participants
Standard of care prescribed erythropoietin dose.
|
|---|---|---|
|
Change in Erythropoietin Dose
|
-8700 Units EPO
Standard Deviation 12586
|
-2988 Units EPO
Standard Deviation 10232
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
Erythropoietin Plus Pentoxifylline
Serious events: 12 serious events
Other events: 22 other events
Deaths: 0 deaths
Erythropoietin Alone
Serious events: 12 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Erythropoietin Plus Pentoxifylline
n=24 participants at risk
Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
|
Erythropoietin Alone
n=24 participants at risk
Standard of care prescribed erythropoietin dose.
|
|---|---|---|
|
Infections and infestations
Infection
|
8.3%
2/24 • Number of events 3 • 6 months
|
12.5%
3/24 • Number of events 5 • 6 months
|
|
Cardiac disorders
Cardiac
|
20.8%
5/24 • Number of events 5 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Vascular disorders
Access related
|
4.2%
1/24 • Number of events 2 • 6 months
|
8.3%
2/24 • Number of events 2 • 6 months
|
|
General disorders
Dizziness
|
0.00%
0/24 • 6 months
|
8.3%
2/24 • Number of events 2 • 6 months
|
|
Cardiac disorders
Fluid overload
|
4.2%
1/24 • Number of events 2 • 6 months
|
0.00%
0/24 • 6 months
|
|
General disorders
Other
|
4.2%
1/24 • Number of events 1 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Endocrine disorders
Diabetes
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Electrolyte disorder
|
0.00%
0/24 • 6 months
|
4.2%
1/24 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
GI upset
|
4.2%
1/24 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
4.2%
1/24 • Number of events 1 • 6 months
|
0.00%
0/24 • 6 months
|
Other adverse events
| Measure |
Erythropoietin Plus Pentoxifylline
n=24 participants at risk
Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
|
Erythropoietin Alone
n=24 participants at risk
Standard of care prescribed erythropoietin dose.
|
|---|---|---|
|
Gastrointestinal disorders
GI upset
|
25.0%
6/24 • Number of events 13 • 6 months
|
25.0%
6/24 • Number of events 11 • 6 months
|
|
Infections and infestations
Infection
|
20.8%
5/24 • Number of events 6 • 6 months
|
29.2%
7/24 • Number of events 13 • 6 months
|
|
Vascular disorders
Access-related
|
12.5%
3/24 • Number of events 7 • 6 months
|
16.7%
4/24 • Number of events 6 • 6 months
|
|
General disorders
Other
|
8.3%
2/24 • Number of events 5 • 6 months
|
12.5%
3/24 • Number of events 3 • 6 months
|
|
General disorders
Pain
|
16.7%
4/24 • Number of events 5 • 6 months
|
8.3%
2/24 • Number of events 2 • 6 months
|
|
Cardiac disorders
Cardiac
|
8.3%
2/24 • Number of events 2 • 6 months
|
8.3%
2/24 • Number of events 3 • 6 months
|
Additional Information
Christina Kahn, Senior Manager of Clinical Trials
Fresenius Medical Care North America
Phone: 615-345-5542
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After Sponsor's (S) publication (pub) of multi-center pub,Institution (I) and/or Principal Investigator (PI) may publish data/results from Study based solely upon Study conducted by I/PI,provided that I/PI submits pub to S for review/comment \> 60 days before date of proposed pub.S may review in advance contents of pub.If pub is not submitted within 12 months after termination of Study at all sites,or if S confirms there will be no pub,the I/PI may publish Study results.
- Publication restrictions are in place
Restriction type: OTHER