Trial Outcomes & Findings for 2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients. (NCT NCT00223977)
NCT ID: NCT00223977
Last Updated: 2013-07-08
Results Overview
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
146 participants
Primary outcome timeframe
Baseline to 5 weeks and 9 weeks
Results posted on
2013-07-08
Participant Flow
Participant milestones
| Measure |
Sodium Ferric Gluconate Complex 125 mg
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
325 mg ferrous sulfate three times daily x 8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
46
|
58
|
42
|
|
Overall Study
COMPLETED
|
37
|
47
|
39
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
3
|
Reasons for withdrawal
| Measure |
Sodium Ferric Gluconate Complex 125 mg
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
325 mg ferrous sulfate three times daily x 8 weeks
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
10
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
2
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
Baseline characteristics by cohort
| Measure |
Sodium Ferric Gluconate Complex 125 mg
n=46 Participants
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
n=58 Participants
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
n=42 Participants
325 mg ferrous sulfate three times daily x 8 weeks
|
Total
n=146 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Age Continuous
|
52.5 years
STANDARD_DEVIATION 14.11 • n=5 Participants
|
48.1 years
STANDARD_DEVIATION 12.49 • n=7 Participants
|
51.5 years
STANDARD_DEVIATION 12.88 • n=5 Participants
|
50.5 years
STANDARD_DEVIATION 13.18 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Region of Enrollment
Croatia
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
19 participants
n=5 Participants
|
19 participants
n=7 Participants
|
14 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Region of Enrollment
India
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 5 weeks and 9 weeksPopulation: modified intent to treat (mITT) with last observation carried forward (LOCF) imputation
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Outcome measures
| Measure |
Sodium Ferric Gluconate Complex 125 mg
n=46 Participants
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
n=55 Participants
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
n=42 Participants
325 mg ferrous sulfate three times daily x 8 weeks
|
|---|---|---|---|
|
Hemoglobin
|
1.49 ng/mL
Standard Deviation 1.09
|
0.89 ng/mL
Standard Deviation 1.35
|
1.02 ng/mL
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: Baseline to 5 weeks and 9 weeksChange from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Outcome measures
| Measure |
Sodium Ferric Gluconate Complex 125 mg
n=46 Participants
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
n=55 Participants
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
n=42 Participants
325 mg ferrous sulfate three times daily x 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Hematocrit (Hct)
|
4.62 percent
Standard Deviation 3.37
|
2.93 percent
Standard Deviation 4.61
|
3.07 percent
Standard Deviation 4.59
|
SECONDARY outcome
Timeframe: Baseline to 5 weeks and 9 weeksChange from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Outcome measures
| Measure |
Sodium Ferric Gluconate Complex 125 mg
n=46 Participants
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
n=55 Participants
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
n=42 Participants
325 mg ferrous sulfate three times daily x 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Transferrin Saturation (TSAT).
|
8.13 percent
Standard Deviation 8.77
|
8.2 percent
Standard Deviation 9.31
|
1.84 percent
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline to 5 weeks and 9 weeksChange from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
Outcome measures
| Measure |
Sodium Ferric Gluconate Complex 125 mg
n=46 Participants
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
n=55 Participants
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
n=42 Participants
325 mg ferrous sulfate three times daily x 8 weeks
|
|---|---|---|---|
|
Change From Baseline in Serum Ferritin.
|
259.88 ng/mL
Standard Deviation 212.73
|
368.67 ng/mL
Standard Deviation 270.05
|
26.98 ng/mL
Standard Deviation 86.57
|
SECONDARY outcome
Timeframe: Baseline to 5 weeks and 9 weeksPatients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron.
Outcome measures
| Measure |
Sodium Ferric Gluconate Complex 125 mg
n=46 Participants
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
n=55 Participants
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
n=42 Participants
325 mg ferrous sulfate three times daily x 8 weeks
|
|---|---|---|---|
|
Responders by Treatment Group
|
30 participants
|
22 participants
|
20 participants
|
Adverse Events
Sodium Ferric Gluconate Complex 125 mg
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Sodium Ferric Gluconate Complex 250 mg
Serious events: 13 serious events
Other events: 20 other events
Deaths: 0 deaths
Oral Iron
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sodium Ferric Gluconate Complex 125 mg
n=46 participants at risk
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
n=58 participants at risk
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
n=42 participants at risk
325 mg ferrous sulfate three times daily x 8 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/46
|
0.00%
0/58
|
4.8%
2/42 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
CELLULITIS
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 1
|
|
Vascular disorders
CEREBROVASC ACCID
|
0.00%
0/46
|
1.7%
1/58 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/46
|
1.7%
1/58 • Number of events 1
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
EDEMA LUNG
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 1
|
|
General disorders
FEVER
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
FIBRILLAT ATR
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
HEM RECTAL
|
2.2%
1/46 • Number of events 1
|
0.00%
0/58
|
0.00%
0/42
|
|
Metabolism and nutrition disorders
HYPERGLYCEM
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
HYPERTENS
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 2
|
|
Metabolism and nutrition disorders
HYPERVOLEM
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
HYPOTENS
|
0.00%
0/46
|
8.6%
5/58 • Number of events 5
|
0.00%
0/42
|
|
Cardiac disorders
INFARCT MYOCARD
|
0.00%
0/46
|
1.7%
1/58 • Number of events 1
|
4.8%
2/42 • Number of events 2
|
|
Surgical and medical procedures
INJECT SITE REACT
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 1
|
|
Metabolism and nutrition disorders
KETOSIS
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 1
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.00%
0/46
|
1.7%
1/58 • Number of events 1
|
0.00%
0/42
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/46
|
0.00%
0/58
|
2.4%
1/42 • Number of events 1
|
|
Cardiac disorders
PERICARDITIS
|
0.00%
0/46
|
1.7%
1/58 • Number of events 1
|
0.00%
0/42
|
|
General disorders
PERITONITIS
|
4.3%
2/46 • Number of events 2
|
8.6%
5/58 • Number of events 5
|
0.00%
0/42
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.00%
0/46
|
1.7%
1/58 • Number of events 1
|
0.00%
0/42
|
|
Cardiac disorders
SYNCOPE
|
0.00%
0/46
|
1.7%
1/58 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
ULCER STOMACH
|
0.00%
0/46
|
1.7%
1/58 • Number of events 1
|
0.00%
0/42
|
|
Gastrointestinal disorders
VOMIT
|
0.00%
0/46
|
1.7%
1/58 • Number of events 1
|
0.00%
0/42
|
Other adverse events
| Measure |
Sodium Ferric Gluconate Complex 125 mg
n=46 participants at risk
125 mg sodium ferric gluconate weekly x 8 weeks
|
Sodium Ferric Gluconate Complex 250 mg
n=58 participants at risk
250 mg sodium ferric gluconate complex weekly x 4 weeks
|
Oral Iron
n=42 participants at risk
325 mg ferrous sulfate three times daily x 8 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
LAB TEST ABNORM
|
19.6%
9/46 • Number of events 11
|
13.8%
8/58 • Number of events 8
|
4.8%
2/42 • Number of events 2
|
|
Cardiac disorders
HYPERTENS
|
8.7%
4/46 • Number of events 4
|
10.3%
6/58 • Number of events 6
|
9.5%
4/42 • Number of events 4
|
|
Gastrointestinal disorders
DIARRHEA
|
6.5%
3/46 • Number of events 3
|
5.2%
3/58 • Number of events 3
|
7.1%
3/42 • Number of events 4
|
|
Cardiac disorders
HYPOTENS
|
2.2%
1/46 • Number of events 2
|
6.9%
4/58 • Number of events 6
|
0.00%
0/42
|
|
General disorders
INFECT
|
4.3%
2/46 • Number of events 2
|
1.7%
1/58 • Number of events 1
|
7.1%
3/42 • Number of events 3
|
|
Gastrointestinal disorders
PAIN ABDO
|
2.2%
1/46 • Number of events 1
|
1.7%
1/58 • Number of events 1
|
9.5%
4/42 • Number of events 4
|
|
General disorders
PAIN
|
0.00%
0/46
|
5.2%
3/58 • Number of events 4
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/46
|
5.2%
3/58 • Number of events 3
|
0.00%
0/42
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60