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Erythropoiesis-Stimulating Agent

KER-050 for Anemia in Myelodysplastic Syndromes

Phase 2
Recruiting
Research Sponsored by Keros Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of child-bearing potential and sexually active males must agree to use effective methods of contraception
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (if related to anemia)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from treatment initiation to end of study, approximately 2 years
Awards & highlights

Study Summary

This triallooks at how a drug, KER-050, can help treat anemia in patients with myelodysplastic syndrome (MDS).

Who is the study for?
This trial is for patients with very low to intermediate risk Myelodysplastic Syndromes (MDS) who have anemia. They should not have had recent infections, vitamin deficiencies, or certain treatments like chemotherapy. Participants need a specific white blood cell count and bone marrow blast percentage, and must agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests KER-050's effectiveness on anemia in MDS patients at various risk levels. It aims to see how well the drug improves red blood cell counts without transfusions or if it reduces the need for them in those already receiving transfusions.See study design
What are the potential side effects?
While specific side effects of KER-050 are not listed here, common side effects for drugs treating MDS may include fatigue, nausea, bruising or bleeding more easily due to low platelet counts, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control methods.
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I can care for myself, but my anemia affects my daily activities.
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My condition is a type of blood cancer classified as low to intermediate risk.
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I have anemia and meet the specific blood transfusion criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from treatment initiation to end of study, approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from treatment initiation to end of study, approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs) and serious adverse events (SAEs).
Secondary outcome measures
Change from Baseline in RBC counts and reticulocytes
Duration of erythroid response and modified 2006 IWG HI-E response
Erythroid response in low-transfusion burden (LTB) and high-transfusion burden (HTB) participants.
+6 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: KER-050 Dose Confirmation CohortExperimental Treatment1 Intervention
Participants to receive KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Group II: KER-050 Cohort 5Experimental Treatment1 Intervention
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Group III: KER-050 Cohort 4Experimental Treatment1 Intervention
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Group IV: KER-050 Cohort 3Experimental Treatment1 Intervention
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Group V: KER-050 Cohort 2Experimental Treatment1 Intervention
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 4 cycles. Participants have the option to continue to receive KER-050 once 4 cycles have been completed for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.
Group VI: KER-050 Cohort 1Experimental Treatment1 Intervention
Escalating doses of KER-050 administered subcutaneously every 4 weeks for up to 4 cycles. Participants have the option to continue to receive KER-050 once 4 cycles have been completed for up to 24 cycles. Eligible participants may be able to continue to receive subcutaneously administered KER-050 after completing 24 cycles.

Find a Location

Who is running the clinical trial?

Keros TherapeuticsLead Sponsor
1 Previous Clinical Trials
110 Total Patients Enrolled
Keros Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

KER-050 (Erythropoiesis-Stimulating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04419649 — Phase 2
Myelodysplastic Syndrome Research Study Groups: KER-050 Cohort 2, KER-050 Cohort 1, KER-050 Cohort 3, KER-050 Dose Confirmation Cohort, KER-050 Cohort 4, KER-050 Cohort 5
Myelodysplastic Syndrome Clinical Trial 2023: KER-050 Highlights & Side Effects. Trial Name: NCT04419649 — Phase 2
KER-050 (Erythropoiesis-Stimulating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04419649 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the patient enrolment for this clinical trial?

"That is correct. The online database shows that this study is looking for volunteers and was last updated on November 14th, 2020. 110 individuals are needed from a single location."

Answered by AI

Are there any open positions in this clinical trial?

"That is correct. The latest information on clinicaltrials.gov suggests that this study is looking for 110 individuals to participate between 1 locations. This particular trial was originally posted on 8/19/2020 and was last edited on 11/14/2022."

Answered by AI

What have been the reported dangers associated with KER-050 Cohort 2?

"KER-050 Cohort 2's safety is estimated to be a 2. This drug is in Phase 2, meaning that while there is evidence suggesting it won't cause too many adverse effects, there is no data yet supporting its efficacy."

Answered by AI
~36 spots leftby Jun 2025