Back to resultsA 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).
Primary Purpose
Iron Deficiency Anemia
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KER-047
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Functional Iron Deficiency Anemia (Functional IDA), Myelodysplastic Syndromes (MDS), Myelofibrosis (MF), Myelodysplastic Syndrome (MDS), Myeloproliferative Neoplasm Overlap Syndromes (MPN)
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Sites / Locations
- Royal Adelaide HospitalRecruiting
- Hadassah University Medical CenterRecruiting
- Galilee Medical CenterRecruiting
- Laniado Hospital - Sanz Medical CenterRecruiting
- Shamir Medical Center (Assaf Harofeh Medical Center)Recruiting
- Spitalul Clinic Coltea
- Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
- Spitalul Clinic Municipal Filantropia Craiova
- Spitalul Clinic Judetean de Urgenta Targu Mures
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part 1 (Initial Titration Strategy)
Part 2 (Cohort Expansion or Alternate Titration Strategy)
Arm Description
KER-047(30 mg, 60mg or 80mg) oral tablet daily (or every other day) for up to 24 weeks.
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.
Outcomes
Primary Outcome Measures
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
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
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
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
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.
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
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
Respiratory rate
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Heart rate
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Body temperature
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)
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)
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)
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)
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)
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Secondary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
Full Information
NCT ID
NCT05927012
First Posted
June 8, 2023
Last Updated
October 18, 2023
Sponsor
Keros Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05927012
Brief Title
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).
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2023 (Anticipated)
Primary Completion Date
August 29, 2025 (Anticipated)
Study Completion Date
January 4, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Keros Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Functional Iron Deficiency Anemia (Functional IDA), Myelodysplastic Syndromes (MDS), Myelofibrosis (MF), Myelodysplastic Syndrome (MDS), Myeloproliferative Neoplasm Overlap Syndromes (MPN)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
2 parts: Part 1 Initial Titration Strategy and Part 2 Cohort Expansion or Alternate Titration Strategy
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1 (Initial Titration Strategy)
Arm Type
Experimental
Arm Description
KER-047(30 mg, 60mg or 80mg) oral tablet daily (or every other day) for up to 24 weeks.
Arm Title
Part 2 (Cohort Expansion or Alternate Titration Strategy)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
KER-047
Intervention Description
Oral tablet, daily (or every other day) administration
Primary Outcome Measure Information:
Title
Percentage of participants experiencing Treatment-emergent adverse events (TEAEs)
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Dose limiting toxicities (DLTs)
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Percentage of participants experiencing Treatment-related AEs (Adverse events)
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Number of participants discontinuing due to AEs (Adverse events)
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Change from Baseline in clinical laboratory values
Description
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.
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Systolic Blood Pressure
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Diastolic Blood Pressure
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Respiratory rate
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Heart rate
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Body temperature
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Fridericia corrected QT interval via 12-lead Electrocardiogram (ECG)
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
QT interval via 12-lead Electrocardiogram (ECG)
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
QRS interval via 12-lead Electrocardiogram (ECG)
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
PR interval via 12-lead Electrocardiogram (ECG)
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Body weight (in kg)
Description
To determine safety and tolerability of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Secondary Outcome Measure Information:
Title
Change from baseline in reticulocyte hemoglobin content (RET-He)
Description
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
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Change from baseline in hepcidin concentration
Description
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
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Change from baseline in hemoglobin (Hgb)
Description
To evaluate the effect of KER-047 on anemia in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Proportion of participants who have Hgb increase of ≥1.0 g/dL (0.6 mmol/L)
Description
To evaluate the effect of KER-047 on anemia in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Proportion of participants who have Hgb increase of ≥1.5 g/dL (0.9 mmol/L)
Description
To evaluate the effect of KER-047 on anemia in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks in Part 1 or up to 101 weeks if continuing in the treatment extension
Title
Proportion of RBC-transfused participants who achieve ≥8 weeks of transfusion independence during any consecutive period up to End of Treatment
Description
To evaluate the effect of KER-047 on anemia in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 29 weeks or up to 101 weeks if in the treatment extension
Title
Plasma KER-047 and any metabolites concentration, summarized by time point
Description
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Week 1 and Week 13 in Part 1 and 2
Title
Estimated peak plasma concentration (Cmax)
Description
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Week 1 and Week 13 in Part 1 and 2
Title
Time to peak plasma concentration (Tmax)
Description
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Week 1 and Week 13 in Part 1 and 2
Title
Area under the plasma KER-047 concentration curve (AUClast)
Description
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Week 1 and Week 13 in Part 1 and 2
Title
Mean trough (Ctrough) plasma KER-047 and metabolites of interest concentration
Description
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 25 weeks
Title
Plasma KER-047 and metabolites of interest accumulation (Rac)
Description
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 25 weeks
Title
Determination of steady-state (as appropriate)
Description
To evaluate the Pharmacokinetic (PK) of KER-047 in participants with functional IDA associated with MDS, MF, and MDS/MPN overlap syndromes
Time Frame
Up to 25 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Study Team
Phone
+1 617 314-6297
Email
clinicalstudies@kerostx.com
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Hadassah University Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
2633737
Country
Israel
Individual Site Status
Recruiting
Facility Name
Laniado Hospital - Sanz Medical Center
City
Netanya
ZIP/Postal Code
4244916
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shamir Medical Center (Assaf Harofeh Medical Center)
City
Zrifin
ZIP/Postal Code
7033001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic Coltea
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Individual Site Status
Withdrawn
Facility Name
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Withdrawn
Facility Name
Spitalul Clinic Municipal Filantropia Craiova
City
Craiova
ZIP/Postal Code
200143
Country
Romania
Individual Site Status
Withdrawn
Facility Name
Spitalul Clinic Judetean de Urgenta Targu Mures
City
Târgu-Mureş
ZIP/Postal Code
540136
Country
Romania
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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).
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