Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Recruiting in Palo Alto (17 mi)
+109 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pharmacosmos A/S
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).
Research Team
PA
Pharmacosmos A/S Clinical and Non-clinical Research
Principal Investigator
Pharmacosmos A/S
Eligibility Criteria
Inclusion Criteria
Men and women, ≥ 18 years
Hb ≤ 11 g/dL
Chronic renal impairment, as defined by either (i) eGFR < 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) Estimated Glomerular Filtration Rate (eGFR) < 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model
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Treatment Details
Interventions
- Iron isomaltoside/ferric derisomaltose (Iron Supplement)
- Iron sucrose (Iron Supplement)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Iron isomaltoside/ferric derisomaltoseExperimental Treatment1 Intervention
Administered IV
Group II: Iron sucroseActive Control1 Intervention
Administered IV
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Who Is Running the Clinical Trial?
Pharmacosmos A/S
Lead Sponsor
Trials
45
Recruited
9,700+