Trial Outcomes & Findings for Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease (NCT NCT00317226)
NCT ID: NCT00317226
Last Updated: 2018-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
145 participants
Primary outcome timeframe
44 week study duration
Results posted on
2018-02-20
Participant Flow
Hospitals and medical clinics
no treatment with FCM in the trial excluded 18 subjects from the Safety population
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
|
|---|---|
|
Overall Study
STARTED
|
127
|
|
Overall Study
COMPLETED
|
104
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=127 Participants
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
61 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
66 Participants
n=5 Participants
|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 44 week study durationOutcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=127 Participants
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
|
|---|---|
|
Incidence of Treatment-emergent Adverse Events
|
84 each event
|
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 23 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=127 participants at risk
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.79%
1/127 • 1 year and 8 months
|
|
Cardiac disorders
Angina unstable
|
0.79%
1/127 • 1 year and 8 months
|
|
Cardiac disorders
Coronary artery disease
|
0.79%
1/127 • 1 year and 8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
1/127 • 1 year and 8 months
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.79%
1/127 • 1 year and 8 months
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.79%
1/127 • 1 year and 8 months
|
|
Gastrointestinal disorders
Nausea
|
0.79%
1/127 • 1 year and 8 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.79%
1/127 • 1 year and 8 months
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
1/127 • 1 year and 8 months
|
|
General disorders
Chest pain
|
0.79%
1/127 • 1 year and 8 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.79%
1/127 • 1 year and 8 months
|
|
Infections and infestations
Cellulitis
|
1.6%
2/127 • 1 year and 8 months
|
|
Infections and infestations
Localized infection
|
0.79%
1/127 • 1 year and 8 months
|
|
Infections and infestations
Pyelonephritis
|
0.79%
1/127 • 1 year and 8 months
|
|
Infections and infestations
Urinary tract infection
|
0.79%
1/127 • 1 year and 8 months
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.79%
1/127 • 1 year and 8 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.79%
1/127 • 1 year and 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.79%
1/127 • 1 year and 8 months
|
|
Musculoskeletal and connective tissue disorders
Localized osteoarthritis
|
0.79%
1/127 • 1 year and 8 months
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.79%
1/127 • 1 year and 8 months
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.79%
1/127 • 1 year and 8 months
|
|
Nervous system disorders
Headache
|
0.79%
1/127 • 1 year and 8 months
|
|
Renal and urinary disorders
Azotemia
|
0.79%
1/127 • 1 year and 8 months
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.79%
1/127 • 1 year and 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.79%
1/127 • 1 year and 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.79%
1/127 • 1 year and 8 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.79%
1/127 • 1 year and 8 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.79%
1/127 • 1 year and 8 months
|
|
Vascular disorders
Lymphoedema
|
0.79%
1/127 • 1 year and 8 months
|
Other adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=127 participants at risk
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
|
|---|---|
|
General disorders
Odema peripheral
|
7.1%
9/127 • 1 year and 8 months
|
|
Infections and infestations
Urinary tract infection
|
5.5%
7/127 • 1 year and 8 months
|
|
Vascular disorders
Hypertension
|
5.5%
7/127 • 1 year and 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60