Trial Outcomes & Findings for VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease (NCT NCT00317239)
NCT ID: NCT00317239
Last Updated: 2018-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
255 participants
Primary outcome timeframe
anytime during the study
Results posted on
2018-02-20
Participant Flow
Hospitals and medical clinics
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
|
Ferrous Sulfate Tablets
325 mg/TID x 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
103
|
|
Overall Study
COMPLETED
|
134
|
84
|
|
Overall Study
NOT COMPLETED
|
13
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=147 Participants
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
|
Ferrous Sulfate Tablets
n=103 Participants
325 mg/TID x 8 weeks
|
Total
n=250 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
|
65 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
82 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 13.48 • n=7 Participants
|
65.94 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
147 participants
n=5 Participants
|
103 participants
n=7 Participants
|
250 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: anytime during the studyPopulation: Modified Intent to Treat (mITT) population defined as subjects who received at least 1 dose of study medication, had stable EPO for at least 8 weeks prior to randomization, had at least 1 post-baseline hemoglobin assessment, and who had NDD-CKD characterized by a GFR ≤45 mL/min/1.73²
Outcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=144 Participants
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
|
Ferrous Sulfate Tablets
n=101 Participants
325 mg/TID x 8 weeks
|
|---|---|---|
|
Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL
|
87 participants
|
35 participants
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 13 serious events
Other events: 11 other events
Deaths: 0 deaths
Ferrous Sulfate Tablets
Serious events: 10 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=147 participants at risk
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
|
Ferrous Sulfate Tablets
n=103 participants at risk
325 mg/TID x 8 weeks
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
1.4%
2/147 • 1 year and 9 months
|
0.97%
1/103 • 1 year and 9 months
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
2/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Cardiac disorders
Myocardial ischemia
|
0.00%
0/147 • 1 year and 9 months
|
0.97%
1/103 • 1 year and 9 months
|
|
Cardiac disorders
Palpitations
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/147 • 1 year and 9 months
|
1.9%
2/103 • 1 year and 9 months
|
|
Gastrointestinal disorders
Intestinal hemorrhage
|
0.00%
0/147 • 1 year and 9 months
|
0.97%
1/103 • 1 year and 9 months
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Infections and infestations
Cellulitis
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Infections and infestations
Sepsis
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Infections and infestations
Skin infection
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Injury, poisoning and procedural complications
Polytraumatism
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/147 • 1 year and 9 months
|
0.97%
1/103 • 1 year and 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/147 • 1 year and 9 months
|
0.97%
1/103 • 1 year and 9 months
|
|
Renal and urinary disorders
Glomerulonephritis proliferative
|
0.00%
0/147 • 1 year and 9 months
|
0.97%
1/103 • 1 year and 9 months
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/147 • 1 year and 9 months
|
1.9%
2/103 • 1 year and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/147 • 1 year and 9 months
|
0.97%
1/103 • 1 year and 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.68%
1/147 • 1 year and 9 months
|
0.00%
0/103 • 1 year and 9 months
|
Other adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=147 participants at risk
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
|
Ferrous Sulfate Tablets
n=103 participants at risk
325 mg/TID x 8 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.4%
2/147 • 1 year and 9 months
|
17.5%
18/103 • 1 year and 9 months
|
|
General disorders
Odema peripheral
|
6.1%
9/147 • 1 year and 9 months
|
1.9%
2/103 • 1 year and 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60