A Study to Evaluate the Safety and Preliminary Efficacy of a Response-guided Dose Titration of KER-047 in the Treatment of Functional IDA (Iron Deficiency Anemia).
← catalyst calendarSponsored by Keros Therapeutics, Inc. (industry) · KROS — their whole pipeline →.
Phase
Phase 2
Status
Withdrawn
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
0actual
Sites
5
Countries
Australia, Israel
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Despite several attempts to recruit eligible participants and major protocol amendments to increase the recruitment rate, recruitment challenges remained. Therefore, the Sponsor has made the decision to terminate the KER047-IR-202 Study globally.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-11-30 | estimated | When the study began enrolling |
| Primary completion | 2025-08-29 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-01-04 | estimated | The whole study's end, after follow-up |
| First posted | 2023-07-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2023-11-24 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Iron Deficiency Anemia
Intervention
- Drug: KER-047
Primary outcomes
what the primary-completion date above is the date OFPercentage of participants experiencing Treatment-emergent adverse events (TEAEs)
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Dose limiting toxicities (DLTs)
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Percentage of participants experiencing Treatment-related AEs (Adverse events)
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Number of participants discontinuing due to AEs (Adverse events)
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Change from Baseline in clinical laboratory values
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Systolic Blood Pressure
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Diastolic Blood Pressure
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Respiratory rate
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Heart rate
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Body temperature
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Fridericia corrected QT interval via 12-lead Electrocardiogram (ECG)
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
QT interval via 12-lead Electrocardiogram (ECG)
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
QRS interval via 12-lead Electrocardiogram (ECG)
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
PR interval via 12-lead Electrocardiogram (ECG)
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Body weight (in kg)
measured Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Permalink · KROS's whole pipeline · Catalyst calendar · Every registered study · What changed