Anemia
Conditions
Keywords
Anemia, CKD, Chronic Kidney Disease, Iron, Maintenance Dose
Brief summary
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).
Detailed description
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004. In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.
Interventions
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Sponsors
American Regent, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who completed or discontinued Protocol 1VIT04004
Exclusion criteria
* Known hypersensitivity reaction to VIT-45 * Anemia not related to CKD * Chronic, serious infection * Recent IV iron other than study drug in past 12 weeks * Recent blood loss within the last 12 weeks * Need for surgery or dialysis * Female subjects who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-emergent Adverse Events | 44 week study duration |
Countries
United States
Participant flow
Recruitment details
Hospitals and medical clinics
Pre-assignment details
no treatment with FCM in the trial excluded 18 subjects from the Safety population
Participants by arm
| Arm | Count |
|---|---|
| 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 | 127 |
| Total | 127 |
Baseline characteristics
| Characteristic | Ferric Carboxymaltose (FCM) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 66 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants |
| Age, Continuous | 65.6 years STANDARD_DEVIATION 13.39 |
| Region of Enrollment United States | 127 participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 23 / 127 |
| serious Total, serious adverse events | 23 / 127 |
Outcome results
Primary
Incidence of Treatment-emergent Adverse Events
Time frame: 44 week study duration
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ferric Carboxymaltose (FCM) | Incidence of Treatment-emergent Adverse Events | 84 each event |