Iron Deficiency AnemiaPhase 2NCT05927012

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).

A Phase 2 study testing KER-047 in people with Iron Deficiency Anemia, run by Keros Therapeutics, Inc. at 5 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

This study aims to explore the safety and preliminary efficacy of a response-guided dose titration of KER-047 in the treatment of functional IDA (Iron deficiency anemia) in MDS (Myelodysplastic syndrome), MF(Myelofibrosis), and MDS/MPN (Myeloproliferative neoplasm) overlap syndromes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Iron Deficiency Anemia
What is being tested?: KER-047
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 5 sitesin 2 countries
Study dates: 30 Nov 2023to 4 Jan 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female ≥18 years of age, at the time of signing informed consent.
One of the following:
Diagnosis of MDS according to the 2016 World Health Organization (WHO) classification that meets Revised International Prognostic Scoring System (IPSS-R) classification of very low, low, or intermediate risk disease with bone marrow blast percentage <5% within 6 months prior to Day 1 (D1).
Diagnosis of primary myelofibrosis, post polycythemia vera MF, or post-essential thrombocytopenia MF according to the 2017 WHO criteria with bone marrow and peripheral blood blast percentage <2%, or stable between 2% to 5% over 6 months.
Diagnosis of MDS/MPN overlap syndromes according to the 2016 WHO classification, with bone marrow blast percentage <5% within 6 months prior to D1.
Anemia with iron-restricted erythropoiesis as assessed by laboratory criteria during screening.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations.
Females of childbearing potential and sexually active males must meet the contraception requirements as outlined in the protocol.

Who cannot join

Active infection within 14 days of D1.
IPSS-R score indicating high or very high risk MDS, accelerated myelofibrosis (defined as >10% blasts), or diagnosis of acute leukemia.
Diagnosis of hemolytic anemia.
Diagnosis of porphyria.
Anemia due to blood loss 28 days prior to D1.
Diagnosis of thalassemia, thalassemia trait, or other hemoglobinopathy.

Show all 9Show fewer

History of drug or alcohol abuse, as defined by the Investigator, within the past 2 years.
History of stroke, arterial embolism, or deep venous thrombosis within 6 months prior to D1.
Known positive for human immunodeficiency virus, active infectious hepatitis B virus or active infectious hepatitis C virus.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Israel4 sites

Hadassah University Medical Center
Jerusalem, 9112001
Galilee Medical Center
Nahariya, 2633737
Laniado Hospital - Sanz Medical Center
Netanya, 4244916
Shamir Medical Center (Assaf Harofeh Medical Center)
Zrifin, 7033001

Other trials in Israel

Australia1 site

Royal Adelaide Hospital
Adelaide, South Australia, 5000

Other trials in Australia

About this study

Official title: A Phase 2, Intrapatient Dose Titration Study of KER-047 in Participants With Functional Iron Deficiency Anemia Associated With Myelodysplastic Syndromes, Myelofibrosis, and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes

Read the detailed description

This is a Phase 2 multicenter, open-label study being conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of response-guided dose titration of KER-047 in adult participants with functional iron deficiency anemia (IDA) associated with myelodysplastic syndrome (MDS), myelofibrosis (MF), and myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN) overlap syndromes. Approximately 20 patients will be enrolled. Dosing of KER-047 may be adjusted based on safety/tolerability and treatment response. The study will be conducted in 2 parts: Part 1 Initial Titration Strategy and Part 2 Cohort Expansion or Alternate Titration Strategy.

The total planned duration of participation for an individual participant is approximately 32 weeks (4-week screening phase, 24-week treatment period, and 4-week follow-up period). For participants in the extension phase, the maximum duration of participation would be approximately 104 weeks (2 years) (4-week screening phase, 24-week treatment period, 18 month [72 weeks] extension period, and 4-week follow-up period).

Conditions: Iron Deficiency Anemia
Being tested: KER-047
Keywords: Functional Iron Deficiency Anemia (Functional IDA), Myelodysplastic Syndromes (MDS), Myelofibrosis (MF), Myelodysplastic Syndrome (MDS), Myeloproliferative Neoplasm Overlap Syndromes (MPN)
Medical subject headings: Anemia, Iron-Deficiency, Myelodysplastic Syndromes, Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KER-047Drug
Oral tablet, daily (or every other day) administration

Study groups in NCT05927012
Study group	Role	What they receive
Part 1 (Initial Titration Strategy)	Experimental	KER-047(30 mg, 60mg or 80mg) oral tablet daily (or every other day) for up to 24 weeks. Receives: Drug: KER-047
Part 2 (Cohort Expansion or Alternate Titration Strategy)	Experimental	The starting dose regimen and titration schedule of KER-047 oral tablet will be based on the SRC (Safety Review Committee) recommendation from Part 1. Receives: Drug: KER-047

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of participants experiencing Treatment-emergent adverse events (TEAEs)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Dose limiting toxicities (DLTs)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
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)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
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)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
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
To determine the safety and tolerability based on changes from baseline in select clinical laboratory parameters including: Alkaline phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Glucose, Potassium, Sodium, Total bilirubin, Folate, WBC count, Platelet Count, Reticulocyte Count, Transferrin Saturation percentage.
Note - Select safety parameters will be listed as separate outcomes during results update.
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Systolic Blood Pressure
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Diastolic Blood Pressure
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Respiratory rate
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Heart rate
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Body temperature
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
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)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
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)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
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)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
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)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Body weight (in kg)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension

Secondary outcomes (13)

Change from baseline in reticulocyte hemoglobin content (RET-He)
To evaluate the Pharmacodynamic (PD) effects of KER-047 on iron metabolism in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Change from baseline in hepcidin concentration
To evaluate the Pharmacodynamic (PD) effects of KER-047 on iron metabolism in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Change from baseline in hemoglobin (Hgb)
To evaluate the effect of KER-047 on anemia in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Proportion of participants who have Hgb increase of ≥1.0 g/dL (0.6 mmol/L)
To evaluate the effect of KER-047 on anemia in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Proportion of participants who have Hgb increase of ≥1.5 g/dL (0.9 mmol/L)
To evaluate the effect of KER-047 on anemia in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Proportion of RBC-transfused participants who achieve ≥8 weeks of transfusion independence during any consecutive period up to End of Treatment
To evaluate the effect of KER-047 on anemia in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 29 weeks or up to 101 weeks if in the treatment extension
Plasma KER-047 and any metabolites concentration, summarized by time point
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Week 1 and Week 13 in Part 1 and 2
Estimated peak plasma concentration (Cmax)
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Week 1 and Week 13 in Part 1 and 2
Time to peak plasma concentration (Tmax)
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Week 1 and Week 13 in Part 1 and 2
Area under the plasma KER-047 concentration curve (AUClast)
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Week 1 and Week 13 in Part 1 and 2
Mean trough (Ctrough) plasma KER-047 and metabolites of interest concentration
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 25 weeks
Plasma KER-047 and metabolites of interest accumulation (Rac)
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 25 weeks
Determination of steady-state (as appropriate)
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Measured: Up to 25 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 20234 Jan 2026

First posted3 Jul 2023
Study start30 Nov 2023 (estimated)
Primary completion29 Aug 2025 (estimated)
Study completion4 Jan 2026 (estimated)

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: 2 parts: Part 1 Initial Titration Strategy and Part 2 Cohort Expansion or Alternate Titration Strategy
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05927012
Sponsor's protocol ID: KER047-IR-202
Status last verified: Nov 2023
First submitted: 8 Jun 2023
Last updated: 24 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Iron Deficiency Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Intrapatient Dose Titration Study of KER-047 in Participants With Functional Iron Deficiency Anemia Associated With Myelodysplastic Syndromes, Myelofibrosis, and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes
ClinicalTrials.gov ID: NCT05927012
Acronym / sponsor ID: KER047-IR-202
Conditions: Iron Deficiency Anemia
Keywords: Functional Iron Deficiency Anemia (Functional IDA), Myelodysplastic Syndromes (MDS), Myelofibrosis (MF), Myelodysplastic Syndrome (MDS), Myeloproliferative Neoplasm Overlap Syndromes (MPN)
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: 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.
Enrolment: 0 participants (actual)
Lead sponsor: Keros Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 30 Nov 2023 (estimated)
Primary completion: 29 Aug 2025 (estimated)
Study completion: 4 Jan 2026 (estimated)
First posted: 3 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: 2 parts: Part 1 Initial Titration Strategy and Part 2 Cohort Expansion or Alternate Titration Strategy

Arm	Type	Receives
Part 1 (Initial Titration Strategy)	Experimental	Drug: KER-047KER-047(30 mg, 60mg or 80mg) oral tablet daily (or every other day) for up to 24 weeks.
Part 2 (Cohort Expansion or Alternate Titration Strategy)	Experimental	Drug: KER-047The starting dose regimen and titration schedule of KER-047 oral tablet will be based on the SRC (Safety Review Committee) recommendation from Part 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female ≥18 years of age, at the time of signing informed consent.
One of the following:
Anemia with iron-restricted erythropoiesis as assessed by laboratory criteria during screening.
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local study participant privacy regulations.
Females of childbearing potential and sexually active males must meet the contraception requirements as outlined in the protocol.

Key exclusion criteria (9 listed)

Active infection within 14 days of D1.
IPSS-R score indicating high or very high risk MDS, accelerated myelofibrosis (defined as >10% blasts), or diagnosis of acute leukemia.
Diagnosis of hemolytic anemia.
Diagnosis of porphyria.
Anemia due to blood loss 28 days prior to D1.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KER-047Oral tablet, daily (or every other day) administration	Drug	Part 1 (Initial Titration Strategy), Part 2 (Cohort Expansion or Alternate Titration Strategy)

Primary outcome

Percentage of participants experiencing Treatment-emergent adverse events (TEAEs)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Dose limiting toxicities (DLTs)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Percentage of participants experiencing Treatment-related AEs (Adverse events)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Number of participants discontinuing due to AEs (Adverse events)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Change from Baseline in clinical laboratory values
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine the safety and tolerability based on changes from baseline in select clinical laboratory parameters including: Alkaline phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Glucose, Potassium, Sodium, Total bilirubin, Folate, WBC count, Platelet Count, Reticulocyte Count, Transferrin Saturation percentage. Note - Select safety parameters will be listed as separate outcomes during results update.
Systolic Blood Pressure
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Diastolic Blood Pressure
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Respiratory rate
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Heart rate
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Body temperature
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Fridericia corrected QT interval via 12-lead Electrocardiogram (ECG)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
QT interval via 12-lead Electrocardiogram (ECG)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
QRS interval via 12-lead Electrocardiogram (ECG)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
PR interval via 12-lead Electrocardiogram (ECG)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Body weight (in kg)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes

13 secondary outcomes

Change from baseline in reticulocyte hemoglobin content (RET-He)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Change from baseline in hepcidin concentration
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Change from baseline in hemoglobin (Hgb)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Proportion of participants who have Hgb increase of ≥1.0 g/dL (0.6 mmol/L)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Proportion of participants who have Hgb increase of ≥1.5 g/dL (0.9 mmol/L)
Time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Proportion of RBC-transfused participants who achieve ≥8 weeks of transfusion independence during any consecutive period up to End of Treatment
Time frame: Up to 29 weeks or up to 101 weeks if in the treatment extension
Plasma KER-047 and any metabolites concentration, summarized by time point
Time frame: Week 1 and Week 13 in Part 1 and 2
Estimated peak plasma concentration (Cmax)
Time frame: Week 1 and Week 13 in Part 1 and 2
Time to peak plasma concentration (Tmax)
Time frame: Week 1 and Week 13 in Part 1 and 2
Area under the plasma KER-047 concentration curve (AUClast)
Time frame: Week 1 and Week 13 in Part 1 and 2
Mean trough (Ctrough) plasma KER-047 and metabolites of interest concentration
Time frame: Up to 25 weeks
Plasma KER-047 and metabolites of interest accumulation (Rac)
Time frame: Up to 25 weeks
Determination of steady-state (as appropriate)
Time frame: Up to 25 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
Individual participant dataSharing planned: Undecided

Related trials for Iron Deficiency Anemia

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KER-047 in people with Iron Deficiency Anemia, run by Keros Therapeutics, Inc. at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Israel, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants experiencing Treatment-emergent adverse events (TEAEs) (time frame: Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05927012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.