ISRCTN82615441
Completed
Phase 3
A multi-centre, randomised, controlled, phase iii study to investigate the safety and efficacy of intravenous infusions of VIT-45 in patients with iron deficiency anaemia secondary to chronic inflammatory bowel disease
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Iron deficiency anaemia secondary to chronic inflammatory bowel disease
- Sponsor
- Vifor (International) Inc.
- Enrollment
- 252
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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