Iron deficiency anemia due to non-dialysis dependent chronic kidney disease or iron deficiency anemia who are intolerant or unresponsive to oral iron.
Conditions
Interventions
Trade Name: Monoferric
Product Name: Monoferric
Pharmaceutical Form: Solution for injection/infusion
Sponsors
Pharmacosmos A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in the trial if he/she fulfils the following criteria: 1. Subjects =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this trial if he/she fulfils any of the following criteria: 1. Anemia caused by factors other than IDA according to Investigator's judgment 2. S-ferritin >600 ng/mL 3. Hb =5.0 g/dL 4. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis) 5. ALAT and/or ASAT >2 times upper limit of normal (e.g. decompensated liver cirrhosis or active hepatitis) 6. Pregnant or nursing female subjects. In order to avoid pregnancy, female subjects of childbearing potential have to use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) or be abstinent during the whole trial period and 7 days after the last dosing. Childbearing potential refers to all female subjects =12 years old or <12 years old who have started menstruating 7. Previous serious hypersensitivity reactions to any IV iron compounds including ferric derisomaltose 8. Received an investigational drug within 30 days prior to screening 9. Treatment with IV iron within 10 days prior to screening 10. Treatment with blood transfusion, radiotherapy, chemotherapy or other drugs that suppress the bone marrow, and drugs which have anemia as side effect within 30 days prior to screening 11. Planned elective surgery (or planned surgery during the trial period) where significant blood loss is expected within the last 30 days prior to screening 12. Any non-viral infection (non-viral infection that has been fully treated before the baseline visit is accepted) 13. Any other laboratory abnormality, medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject’s disease management at risk or may result in the subject being unable to comply with the trial requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Ability of IV ferric derisomaltose to increase Hb.;Secondary Objective: Effect of ferric derisomaltose on relevant iron related biochemical parameters. PK parameters (only obtained from the first 8 subjects in each age cohort). Safety of IV ferric derisomaltose.;Primary end point(s): Incidence of subjects with a Hb increase of =1 g/dL (NDD-CKD) or 2 g/dL (intolerant or unresponsive to oral iron) from baseline at any time from week 1 to week 8 in the absence of transfusions or ESA dose change or other iron supplementation.;Timepoint(s) of evaluation of this end point: From baseline at any time from week 1 to week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to increase Hb =1 g/dL (NDD-CKD) or 2 g/dL (intolerant or unresponsive to oral iron) • Incidence of subjects who achieve a serum (s-) ferritin of =100 ng/mL at weeks 1, 2, 4, and 8 • Incidence of subjects who achieve a transferrin saturation (TSAT) of =35 % (NDD-CKD) or =20 % (intolerant or unresponsive to oral iron) at weeks 1, 2, 4, and 8 • Change in Hb, s-ferritin, TSAT, and s-iron from baseline to weeks 1, 2, 4, and 8;Timepoint(s) of evaluation of this end point: At weeks 1, 2, 4, and 8 | — |
Countries
United States
Contacts
Public ContactClinical R&D
Pharmacosmos A/S
Outcome results
None listed