Phase 3
N=167
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
Renal Insufficiency, Chronic · Iron-Deficiency Anemia
Bottom Line
View on ClinicalTrials.gov: NCT02968368 ↗Enrolled (actual)
167
Serious AEs
24.3%
Results posted
May 2020
Primary outcome: Primary: Change in Hb Concentration From Baseline to Week 16 — 0.50; -0.02 g/dl — p=0.0149
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferric maltol (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shield Therapeutics
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hb Concentration From Baseline to Week 16 |
0.50; -0.02 | 0.0149 sig |
| SECONDARY Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16 |
22; 5 | — |
| SECONDARY Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16 |
30; 7 | — |
| SECONDARY Change in Hb Concentration From Baseline to Week 8 |
0.53; 0.00 | — |
| SECONDARY Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16 |
7; 0 | — |
| SECONDARY Changes in Ferritin From Baseline to Week 16 |
33.13; -5.90 | 0.0006 sig |
| SECONDARY Number of Participants With (TEAEs) |
75; 42 | — |
| SECONDARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) |
27; 9 | — |
| SECONDARY Changes in TSAT From Baseline to Week 16 |
4.32; -0.15 | 0.0007 sig |
| SECONDARY Changes in Iron Parameter From Baseline to Week 16 |
1.87; 0.01 | 0.0098 sig |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
76; 35 | — |
| SECONDARY Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) |
27; 9 | — |
Summary
To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
Eligibility Criteria
Inclusion Criteria
- Ability to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved information sheet and consent form. Must sign and date the informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations prior to any study mandated procedure.
- Willing and able to comply with study requirements.
- Age ≥ 18 years at the time of informed consent.
- A current diagnosis of CKD with an estimated glomerular filtration rate (eGFR) of 3 times the upper limit of normal as assessed via screening laboratory results.
- Clinically significant vitamin B12 or folic acid deficiency as determined by the screening laboratory results (retest following at least 2 weeks of starting treatment with vitamin B12 or folate replacement is permitted).
- Pregnant or breast feeding.
- Concomitant medical conditions with significant active bleeding likely to initiate or prolong anemia; for example coagulation disorders or recurrent GI bleeding.
- Scheduled or expected major surgery during the course of the study. (Minor surgeries not associated with significant blood loss, in the Investigator's judgement, are permitted e.g. surgery related to fistulae or vascular access, minor dental extractions, incision and drainage of abscess or simple excisions).
- Participation in any other interventional clinical study within 30 days prior to screening.
- Cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject.
- Any other unspecified reason that, in the opinion of the Investigator or the Sponsor make the subject unsuitable for enrolment.
Data sourced from ClinicalTrials.gov (NCT02968368). 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.