Trial Outcomes & Findings for Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia (NCT NCT00236977)
NCT ID: NCT00236977
Last Updated: 2020-10-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
182 participants
Primary outcome timeframe
Change from Baseline up to Day 56
Results posted on
2020-10-06
Participant Flow
Recruitment period: August 2003 to October 2004. Locations: Hospitals, Medical Clinics
Eligibility requirements: Serum Transferrin Saturation (TSAT) \<= to 25%, Ferritin \<= to 300 ng/mL, and no iron following enrollment. At randomization subjects were stratified by gender, hemoglobin (Hgb) levels (\< or = to 9.0 g/dL, 9.1 - 10.0 g/dL, 10.1 - 11.0 g/dL), and erythropoietin use.
Participant milestones
| Measure |
Venofer
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
91
|
|
Overall Study
COMPLETED
|
70
|
72
|
|
Overall Study
NOT COMPLETED
|
21
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Baseline characteristics by cohort
| Measure |
Venofer
n=91 Participants
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=91 Participants
oral iron tablets; 325 mg three times a day orally for 56 days
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
92 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=93 Participants
|
48 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
126 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
56 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline up to Day 56Population: Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.
Outcome measures
| Measure |
Venofer
n=79 Participants
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=82 Participants
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Patients With an Increase in Hemoglobin >= 1gm/dL.
|
35 participants
|
23 participants
|
SECONDARY outcome
Timeframe: Change from Baseline up to Day 56Population: Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.
Clinical Response (change in Hemoblobin (Hgb) \>= 1gm/dL and change in ferritin \>= 160ng/ml)
Outcome measures
| Measure |
Venofer
n=79 Participants
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=82 Participants
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Number of Subjects With a Clinical Response
|
31 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Change from Baseline up to Day 56Population: Only subjects who completed the study from the Intent to Treat (ITT) population.
Outcome measures
| Measure |
Venofer
n=67 Participants
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=65 Participants
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56
|
1.1 g/dL
Standard Deviation .94
|
.8 g/dL
Standard Deviation .78
|
SECONDARY outcome
Timeframe: Change from Baseline up to Day 56Population: Only subjects who completed the study from the Intent to Treat (ITT) population.
Outcome measures
| Measure |
Venofer
n=67 Participants
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=65 Participants
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Highest Change From Baseline in Ferritin (ng/mL) up to Day 56
|
391.7 ng/mL
Standard Deviation 213.19
|
45 ng/mL
Standard Deviation 52.19
|
SECONDARY outcome
Timeframe: Change from Baseline at Day 56Outcome measures
| Measure |
Venofer
n=79 Participants
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=82 Participants
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Mean Change in Ferritin (ng/mL) From Baseline to Day 56
|
230 ng/mL
Standard Deviation 138.2
|
30 ng/mL
Standard Deviation 54.63
|
SECONDARY outcome
Timeframe: Change from Baseline at Day 56Population: Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.
Outcome measures
| Measure |
Venofer
n=79 Participants
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=82 Participants
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56
|
8.5 percentage of change
Standard Deviation 8.31
|
5.5 percentage of change
Standard Deviation 9.14
|
SECONDARY outcome
Timeframe: Change from Baseline at Day 56Population: Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization.
Outcome measures
| Measure |
Venofer
n=79 Participants
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=82 Participants
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Mean Change From Baseline in Hemoglobin (g/dL) at Day 56
|
.7 g/dL
Standard Deviation .94
|
.3 g/dL
Standard Deviation .90
|
Adverse Events
Venofer
Serious events: 10 serious events
Other events: 37 other events
Deaths: 0 deaths
Ferrous Sulfate
Serious events: 6 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Venofer
n=91 participants at risk
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=91 participants at risk
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
|
Surgical and medical procedures
Fracture reduction
|
0.00%
0/91 • 1 year and 2 months
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/91 • 1 year and 2 months
|
2.2%
2/91 • Number of events 2 • 1 year and 2 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Vascular disorders
Hypotension NOS
|
2.2%
2/91 • Number of events 2 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Injury, poisoning and procedural complications
Intraoperative haemorrhage
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Infections and infestations
Lobar pneumonia NOS
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
General disorders
Mental status changes
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Infections and infestations
Pneumonia NOS
|
0.00%
0/91 • 1 year and 2 months
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
|
Renal and urinary disorders
Renal failure acute
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Infections and infestations
Sepsis NOS
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/91 • 1 year and 2 months
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
Other adverse events
| Measure |
Venofer
n=91 participants at risk
iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
|
Ferrous Sulfate
n=91 participants at risk
oral iron tablets; 325 mg three times a day orally for 56 days
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.5%
5/91 • Number of events 5 • 1 year and 2 months
|
12.1%
11/91 • Number of events 11 • 1 year and 2 months
|
|
Gastrointestinal disorders
Diarrhea NOS
|
5.5%
5/91 • Number of events 5 • 1 year and 2 months
|
9.9%
9/91 • Number of events 9 • 1 year and 2 months
|
|
Nervous system disorders
Dizziness
|
5.5%
5/91 • Number of events 6 • 1 year and 2 months
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
|
Gastrointestinal disorders
Dysgeusia
|
7.7%
7/91 • Number of events 12 • 1 year and 2 months
|
0.00%
0/91 • 1 year and 2 months
|
|
General disorders
Fatigue
|
3.3%
3/91 • Number of events 4 • 1 year and 2 months
|
6.6%
6/91 • Number of events 6 • 1 year and 2 months
|
|
Investigations
Fecal Occult Blood Positive
|
2.2%
2/91 • Number of events 2 • 1 year and 2 months
|
5.5%
5/91 • Number of events 7 • 1 year and 2 months
|
|
Vascular disorders
Hypertension NOS
|
5.5%
5/91 • Number of events 5 • 1 year and 2 months
|
2.2%
2/91 • Number of events 2 • 1 year and 2 months
|
|
Gastrointestinal disorders
Nausea
|
5.5%
5/91 • Number of events 5 • 1 year and 2 months
|
9.9%
9/91 • Number of events 10 • 1 year and 2 months
|
|
General disorders
Oedema NOS
|
4.4%
4/91 • Number of events 4 • 1 year and 2 months
|
8.8%
8/91 • Number of events 8 • 1 year and 2 months
|
|
General disorders
Oedema peripheral
|
7.7%
7/91 • Number of events 8 • 1 year and 2 months
|
2.2%
2/91 • Number of events 2 • 1 year and 2 months
|
|
Infections and infestations
Urinary Tract Infection NOS
|
1.1%
1/91 • Number of events 1 • 1 year and 2 months
|
6.6%
6/91 • Number of events 6 • 1 year and 2 months
|
|
Gastrointestinal disorders
Vomiting NOS
|
3.3%
3/91 • Number of events 3 • 1 year and 2 months
|
6.6%
6/91 • Number of events 6 • 1 year and 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60