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Trial Outcomes & Findings for Iron Indices and Intravenous Ferumoxytol: Time to Steady State (NCT NCT01148745)

NCT ID: NCT01148745

Last Updated: 2012-03-30

Results Overview

TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values \<0.05 were considered statistically significant.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration

Results posted on

2012-03-30

Participant Flow

Participant milestones

Participant milestones
Measure
Ferumoxytol
2 doses of 510 mg IV over 17 seconds separated by 3 days
Overall Study
STARTED
15
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iron Indices and Intravenous Ferumoxytol: Time to Steady State

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ferumoxytol
n=15 Participants
2 doses of 510 mg IV over 17 seconds separated by 3 days
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=5 Participants
Age, Categorical
>=65 years
6 Participants
n=5 Participants
Age Continuous
60 years
STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
Region of Enrollment
United States
15 participants
n=5 Participants

PRIMARY outcome

Timeframe: pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration

TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values \<0.05 were considered statistically significant.

Outcome measures

Outcome measures
Measure
Ferumoxytol
n=15 Participants
All participants received 510 mg IV ferumoxytol at both visits 1 and 2.
Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize
2 weeks

SECONDARY outcome

Timeframe: 7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.

Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100

Outcome measures

Outcome measures
Measure
Ferumoxytol
n=15 Participants
All participants received 510 mg IV ferumoxytol at both visits 1 and 2.
Transferrin Saturation (TSAT)
TSAT at day 7 (visit 5)
27.6 percent
Interval 14.7 to 54.4
Transferrin Saturation (TSAT)
TSAT at day 14 (visit 8)
26.7 percent
Interval 14.7 to 45.3
Transferrin Saturation (TSAT)
TSAT at day 21 (visit 11)
23.9 percent
Interval 17.0 to 33.3
Transferrin Saturation (TSAT)
TSAT at day 28 (visit 14)
26.7 percent
Interval 15.2 to 57.0

SECONDARY outcome

Timeframe: 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)

Serum ferritin values were measured at all visits

Outcome measures

Outcome measures
Measure
Ferumoxytol
n=15 Participants
All participants received 510 mg IV ferumoxytol at both visits 1 and 2.
Serum Ferritin
Ferritin at day 7 (visit 5)
912 g/mL
Interval 679.0 to 1257.0
Serum Ferritin
Ferritin at day 14 (visit 8)
713 g/mL
Interval 535.0 to 1236.0
Serum Ferritin
Ferritin at day 21 (visit 11)
679 g/mL
Interval 590.0 to 1257.0
Serum Ferritin
Ferritin at day 28 (visit 14)
670 g/mL
Interval 527.0 to 3172.0

Adverse Events

Ferumoxytol

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Toros Kapoian, M.D., F.A.C.P.

Dialysis Clinic, Inc.

Phone: 732-940-8368

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place