Trial Outcomes & Findings for Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents (NCT NCT00224042)
NCT ID: NCT00224042
Last Updated: 2012-03-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
Baseline
Results posted on
2012-03-29
Participant Flow
Participant milestones
| Measure |
Ferrlecit
Sodium ferric gluconate complex in sucrose injection
|
Oral Iron
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Ferrlecit
Sodium ferric gluconate complex in sucrose injection
|
Oral Iron
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Did not meet lab incusion criteria
|
2
|
3
|
|
Overall Study
Other
|
2
|
0
|
Baseline Characteristics
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
Baseline characteristics by cohort
| Measure |
Ferrlecit
n=26 Participants
Sodium ferric gluconate complex in sucrose injection
|
Oral Iron
n=26 Participants
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Age Continuous
|
67.4 years
STANDARD_DEVIATION 17.75 • n=99 Participants
|
66.1 years
STANDARD_DEVIATION 14.65 • n=107 Participants
|
66.8 years
STANDARD_DEVIATION 16.13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
26 participants
n=107 Participants
|
52 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Ferrlecit
n=24 Participants
Sodium ferric gluconate complex in sucrose injection
|
Oral Iron
n=24 Participants
|
|---|---|---|
|
Baseline Hemoglobin Concentration
|
10.3 g/dL
Standard Deviation 0.90
|
10.4 g/dL
Standard Deviation 0.92
|
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 |
Ferrlecit
n=24 Participants
Sodium ferric gluconate complex in sucrose injection
|
Oral Iron
n=24 Participants
|
|---|---|---|
|
Change in Hemoglobin (Hgb)
|
1.2 g/dL
Standard Deviation 1.23
|
1.0 g/dL
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
Ferrlecit
n=24 Participants
Sodium ferric gluconate complex in sucrose injection
|
Oral Iron
n=24 Participants
|
|---|---|---|
|
Baseline Serum Ferritin Concentration
|
74.3 ng/mL
Standard Deviation 80.95
|
68.7 ng/mL
Standard Deviation 67.36
|
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 |
Ferrlecit
n=24 Participants
Sodium ferric gluconate complex in sucrose injection
|
Oral Iron
n=24 Participants
|
|---|---|---|
|
Change in Serum Ferritin
|
150.0 ng/mL
Standard Deviation 113.11
|
18.1 ng/mL
Standard Deviation 33.66
|
Adverse Events
Ferrlecit
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Oral Iron
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferrlecit
n=26 participants at risk
Sodium ferric gluconate complex in sucrose injection
|
Oral Iron
n=26 participants at risk
|
|---|---|---|
|
Cardiac disorders
Acerbation of Chronic Heart Failure
|
3.8%
1/26 • Number of events 1
|
3.8%
1/26 • Number of events 1
|
|
Renal and urinary disorders
Pyelonephritis
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
General disorders
Pain Chest
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
|
Cardiac disorders
Myocardiac Infarction
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout Attack
|
3.8%
1/26 • Number of events 1
|
0.00%
0/26
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.00%
0/26
|
3.8%
1/26 • Number of events 1
|
Other adverse events
| Measure |
Ferrlecit
n=26 participants at risk
Sodium ferric gluconate complex in sucrose injection
|
Oral Iron
n=26 participants at risk
|
|---|---|---|
|
General disorders
Fever
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Infections and infestations
Infection
|
15.4%
4/26 • Number of events 4
|
0.00%
0/26
|
|
Injury, poisoning and procedural complications
Accidental Injury
|
7.7%
2/26 • Number of events 3
|
0.00%
0/26
|
|
General disorders
Abdominal Pain
|
7.7%
2/26 • Number of events 3
|
0.00%
0/26
|
|
Vascular disorders
Hypertension
|
11.5%
3/26 • Number of events 3
|
0.00%
0/26
|
|
Gastrointestinal disorders
Diarrhea
|
19.2%
5/26 • Number of events 7
|
11.5%
3/26 • Number of events 3
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
15.4%
4/26 • Number of events 6
|
3.8%
1/26 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
2/26 • Number of events 5
|
0.00%
0/26
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Edema
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
|
Metabolism and nutrition disorders
Peripheral Edema
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
11.5%
3/26 • Number of events 3
|
3.8%
1/26 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
7.7%
2/26 • Number of events 2
|
3.8%
1/26 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Increase Cough
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/26
|
7.7%
2/26 • Number of events 2
|
Additional Information
Gary Hoel, RPh, PhD, Executive Director of Clinical Research
Watson Laboratories, Inc.
Phone: 801-588-6641
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60