A multi-centre, multinational clinical study to investigate the safety and effectiveness of intravenous infusions of VIT-45 (Ferinject) in patients with iron deficiency anaemia (IDA) caused by chronic inflammatory bowel disease (IBD) in comparison with oral iron capsules
- Conditions
- Iron deficiency anaemia secondary to chronic inflammatory bowel diseaseSigns and Symptoms
- Registration Number
- ISRCTN82615441
- Lead Sponsor
- Vifor (International) Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 252
1. Male and female, inpatient or outpatient, aged 18 to 80 years (inclusive).
2. Have IDA secondary to chronic IBD (Crohn’s disease or ulcerative colitis).
3. IDA defined as: - Hb = 110 g/L and at least one of the following:
3.1. Serum transferrin saturation (TSAT) < 20%.
3.2. Serum ferritin < 100 µg/L
Hb concentration was defined for inclusion purposes as the mean of 2 qualifying values drawn on different days during the screening period. These 2 days were no more than 14 days an no less than 5 days before baseline. For eligibility, both values had to be =110 g/L or, if one of the two Hb values was greater than 110 g/L, the average of both Hb values had to be =110 g/L and the difference between the two samples was not >10 g/L. Patients who met all criteria, except the last condition were re-screened (i.e., two further Hb assessments on separate days). Also, patients who were previously screened and failed because of the Hb values being >100 g/L, were eligible for re-screening. (changed according to amendment 3, dated 13 October 2004).
4. Required treatment with at least 1000 mg total iron, based on individual assessment of iron deficiency
5. Females of child-bearing potential that have had a negative urine pregnancy test at screening and practised an acceptable method of birth control during the study and for up to 1 month after the last dose of the study medication. Acceptable methods of birth control included:
5.1. Barrier methods (including male and female condoms)
5.2. Diaphragms (cervical caps) with intravaginal spermicide (including jellies, foams and suppositories)
5.3. Intra-uterine devices or hormonal contraceptives
6. Non child-bearing potential including:
6.1. Being surgically sterilised at least 6 months prior to the study
6.2. Postmenopausal with no menstrual bleeding for at least 2 years prior to the study
7. Fertile males that used adequate contraception during the study
8. Demonstrated the ability to understand the requirements of the study, provided written informed consent, abide by the study restrictions, and agreed to undergo the required assessments
1. Blood transfusion or oral or parenteral iron treatment within 30 days prior to enrolment, or anticipated need for a blood transfusion during the study
2. Erythropoietin (EPO) treatment within the 8 weeks prior to enrolment
3. Documented hypersensitivity to components of VIT-45
4. Other types of anaemia (especially haemolytic, macrocytic, hypoplastic, or sideroblastic anaemia).
5. Haemochromatosis or other iron-storage disorders
6. Untreated vitamin B12 or folic acid deficiency (deficiency defined as below the NR)
7. Allergy to acetylsalicylic acid
8. Treatment with an investigational drug within the 30 days prior to enrolment
9. History of addiction to drugs or chronic alcohol abuse
10. Immunosuppressive therapy causing myelosuppression, or need for surgery. For medications permitted see Section 9.4.8
11. Active severe infection or malignancy other than carcinoma in situ of the cervix and non-melanoma skin cancer
12. Active or chronic liver or kidney disease. Serum albumin <25 g/L or serum creatinine >20 mg/L
13. Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgement of the investigator
14. Positive for anti-HIV 1 and 2.
15. Positive for HbsAg, anti-HCV and evidence for active hepatitis, i.e., abnormal liver function test (LFT) results.
16. Pregnant women or nursing mothers.
17. Endocrinologic or metabolic disorders that are not controlled.
18. Prior use of VIT-45 or prior participation in other studies of VIT-45
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Efficacy was assessed through the change from baseline levels of hemoglobin (Hb) to Week 12.<br>2. The following variables were used to assess the safety of the drug: <br>2.1. Adverse Events (AEs) (including discontinuation of treatment due to AEs)<br>2.2. Vital signs<br>2.3. 12-lead electrocardiogram (ECG)<br>2.4. Physical examinations and clinical laboratory panels
- Secondary Outcome Measures
Name Time Method 1. Change from baseline levels of Hb at weeks 2, 4 and 8 and serum ferritin and transferrin saturation (TSAT) at weeks 2, 4, 8 and 12<br>2. Maximum increase in Hb, serum ferritin and TSAT<br>3. The number and proportion of patients who, at weeks 2, 4, 8 and 12, achieved: Hb levels of 135 to 180 g/L for males and 120 to 160 g/L for females<br>4. Serum ferritin levels of 100 to 800 µg/L<br>5. TSAT levels of 20 to 50%; the number and proportion of patients who had, at weeks 2, 4, 8 and 12, Hb levels >20 g/L higher than their baseline level, and whether the patient discontinued due to lack of response<br>6. SF-36v1 questionnaire - change from baseline to weeks 4, 8 and 12