Phase 3
N=1,538
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Iron Deficiency Anaemia · Iron Deficiency Anemia · Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02940860 ↗Enrolled (actual)
1,538
Serious AEs
8.7%
Results posted
Mar 2020
Primary outcome: Primary: Change in Hemoglobin (Hb) From Baseline to Week 8 — 1.22; 1.14 g/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Iron isomaltoside/ferric derisomaltose (Drug); Iron sucrose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmacosmos A/S
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin (Hb) From Baseline to Week 8 |
1.22; 1.14 | — |
| PRIMARY Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions |
3; 0 | — |
| SECONDARY Composite Cardiovascular Adverse Events (AEs) |
42; 35 | 0.0248 sig |
| SECONDARY Time to First Composite Cardiovascular Safety AE |
NA; NA | 0.0185 sig |
| SECONDARY S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 |
32; 4 | — |
| SECONDARY Hb Concentration Increase of ≥1 g/dL From Baseline to Week 1, 2, 4, and 8 |
200; 78; 339; 112; 430; 174 | 0.0478 sig |
| SECONDARY Time to Change in Hb Concentration ≥1 g/dL |
56; 56 | 0.0174 sig |
| SECONDARY Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8 |
259; 121 | 0.5074 |
| SECONDARY Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8 |
307; 133 | 0.1035 |
| SECONDARY S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8 |
873; 388 | <0.0001 sig |
| SECONDARY Change in Hb Concentration From Baseline to Week 1, 2, and 4 |
0.44; 0.21; 0.77; 0.50; 1.08; 0.90 | <0.0001 sig |
| SECONDARY Change in S-ferritin From Baseline to Weeks 1, 2, 4, and 8 |
492.4; 183.9; 381.2; 292.4; 258.4; 255.4 | <0.0001 sig |
| SECONDARY Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8 |
12.10; 4.31; 5.84; 5.64; 4.99; 5.59 | <0.0001 sig |
| SECONDARY Change in Concentration of S-iron From Baseline to Week 1, 2, 4, and 8 |
34.8; 11.1; 11.1; 12.4; 6.5; 10.2 | <0.0001 sig |
| SECONDARY Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8 |
5.04; 5.01; 7.29; 7.63; 9.13; 9.07 | 0.8196 |
| SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car |
19.0; 18.0 | — |
| SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit |
2.00; 2.00; 2.00; 2.00 | — |
| SECONDARY Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits |
152; 57; 70; 26; 410; 197 | — |
| SECONDARY Health Care Resource Use Questionnaire |
1.17; 1.00; 2.58; 2.33 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria includes:
- 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
- Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %
- Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation
- Willingness to participate and signing the informed consent form
Exclusion Criteria includes:
- Anaemia predominantly caused by factors other than IDA
- Hemochromatosis or other iron storage disorders
- Previous serious hypersensitivity reactions to any IV iron compounds
- Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
- Undergoing dialysis for treatment of CKD
- Planned surgical procedure within the trial period
- Decompensated liver cirrhosis or active hepatitis
- Alcohol or drug abuse within the past 6 month.
- Pregnant or nursing women.
Data sourced from ClinicalTrials.gov (NCT02940860). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.