Trial Outcomes & Findings for Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients (NCT NCT00224055)
NCT ID: NCT00224055
Last Updated: 2012-03-29
Results Overview
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
89 participants
Primary outcome timeframe
Baseline to 10 weeks
Results posted on
2012-03-29
Participant Flow
Participant milestones
| Measure |
IV Iron
|
Oral Iron
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
45
|
|
Overall Study
COMPLETED
|
29
|
31
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
| Measure |
IV Iron
|
Oral Iron
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Inclusion Violation
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
Baseline characteristics by cohort
| Measure |
IV Iron
n=44 Participants
|
Oral Iron
n=45 Participants
|
Total
n=89 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
|
29 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age Continuous
|
66.3 years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 14.86 • n=7 Participants
|
64.4 years
STANDARD_DEVIATION 13.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
44 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Region of Enrollment
Puerto Rico
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 10 weeksPopulation: Modified ITT with LOCF imputation
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Outcome measures
| Measure |
IV Iron
n=36 Participants
|
Oral Iron
n=39 Participants
|
|---|---|---|
|
Change in Hemoglobin (Hgb)
|
0.6 g/dL
Standard Deviation 0.94
|
0.2 g/dL
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline to 10 weeksPopulation: Modified ITT with LOCF imputation
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Outcome measures
| Measure |
IV Iron
n=36 Participants
|
Oral Iron
n=39 Participants
|
|---|---|---|
|
Change in Serum Ferritin
|
207.7 ng/mL
Standard Deviation 207.02
|
22.6 ng/mL
Standard Deviation 53.40
|
Adverse Events
IV Iron
Serious events: 4 serious events
Other events: 22 other events
Deaths: 0 deaths
Oral Iron
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IV Iron
n=44 participants at risk
|
Oral Iron
n=45 participants at risk
|
|---|---|---|
|
Metabolism and nutrition disorders
Exacerbation Gout
|
2.3%
1/44 • Number of events 1
|
0.00%
0/45
|
|
Skin and subcutaneous tissue disorders
Lower Exteremities Skin Abcess Lesion
|
0.00%
0/44
|
2.2%
1/45 • Number of events 1
|
|
Vascular disorders
Hypotension
|
4.5%
2/44 • Number of events 2
|
0.00%
0/45
|
|
Renal and urinary disorders
Worsening Chronic Kidney Disease
|
0.00%
0/44
|
2.2%
1/45 • Number of events 1
|
|
Immune system disorders
Anaphylaxis
|
2.3%
1/44 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Pleural Iffusions
|
0.00%
0/44
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.00%
0/44
|
2.2%
1/45 • Number of events 1
|
|
Renal and urinary disorders
Admitted to Hospital for Renal Biopsy
|
0.00%
0/44
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
IV Iron
n=44 participants at risk
|
Oral Iron
n=45 participants at risk
|
|---|---|---|
|
General disorders
Abdominal Enlargement
|
0.00%
0/44
|
6.7%
3/45
|
|
General disorders
Asthenia
|
2.3%
1/44
|
6.7%
3/45
|
|
Infections and infestations
Infection
|
4.5%
2/44
|
6.7%
3/45
|
|
Psychiatric disorders
Abdominal Pain
|
6.8%
3/44
|
4.4%
2/45
|
|
Vascular disorders
Hypotension
|
9.1%
4/44
|
0.00%
0/45
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44
|
8.9%
4/45
|
|
Gastrointestinal disorders
Diarrhea
|
6.8%
3/44
|
6.7%
3/45
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/44
|
6.7%
3/45
|
|
Gastrointestinal disorders
Nausea
|
15.9%
7/44
|
6.7%
3/45
|
|
Gastrointestinal disorders
Vomiting
|
13.6%
6/44
|
4.4%
2/45
|
|
Metabolism and nutrition disorders
Edema
|
6.8%
3/44
|
0.00%
0/45
|
|
Nervous system disorders
Parasthesia
|
6.8%
3/44
|
0.00%
0/45
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60