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We need more options for
myelodysplastic
neoplasms/syndromes
(MDS)

A clinical trial for people with MDS
and anemia is now enrolling.

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Renew Study

About the RENEW Study

The RENEW Study is evaluating a study drug to see if it may safely and effectively reduce the need for blood transfusions due to myelodysplastic neoplasms/syndromes (MDS)-related anemia.

This trial has at least 20 visits, some of which may be done from home.

During the trial, you will have a 2 in 3 (67%) chance of receiving the active study drug and a 1 in 3 (33%) chance of receiving a placebo. A placebo is an inactive material that looks like the study drug but does not contain any active study drug.

The study drug is expected to block a protein in the blood that interferes with your body’s ability to make red blood cells. It will be given by subcutaneous (under the skin) injection about every 4 weeks at the study site.

You may be eligible to participate in this clinical trial if you:*

  • Are over 18 years old
  • Have been diagnosed with very low-, low-, or intermediate-risk MDS
  • Have anemia that must be treated with blood infusions
  • Are no longer benefiting from the initial treatment you received for MDS, or are not expected to benefit from standard treatment
*You may not be eligible to participate if you have received certain treatments for your MDS. The study team will discuss additional criteria with you.
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Clinical Trial
Why Participate

Why Participate?

If you qualify and decide to participate, you will receive:

  • The study drug and all study-related care at no cost
  • Close monitoring by a study doctor and team who are experienced with MDS
  • Reimbursement for costs to attend trial visits, as needed
  • The opportunity to help advance medical knowledge about MDS

Your safety while participating in the RENEW Study is our highest priority. If you have questions or concerns at any point throughout the trial, a study team member is available to speak to you.

Your participation in any clinical trial is voluntary, and you are free to withdraw at any time for any reason. Your privacy will be maintained throughout the trial.

About MDS and Anemia

Myelodysplastic neoplasms/syndromes (MDS) are types of blood cancer. MDS-related anemia is caused when the MDS bone marrow is unable to make enough healthy red blood cells. People with MDS often have anemia, or low red blood cell counts, and require blood transfusions to help relieve their symptoms. These symptoms may include:

  • Excessive fatigue/tiredness
  • Shortness of breath
  • Pale skin
  • Loss of appetite
  • Irregular/fast heartbeat
  • Chest pain
Most people with MDS have some degree of anemia, and approximately half of patients with MDS require regular blood transfusions.1 While there are treatments available for MDS, they do not work for everyone, and not all people qualify to receive them.
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Contact A Trial Site Near You.

Please call the number listed in the location results to confirm the nearest study site. Talk with a study site
member for more information. The information you provide will be kept confidential.
Travel and reimbursement support will be provided.

Frequently Asked Questions

This section will help answer some important questions you may have about participating in this study.

About the RENEW Study

The RENEW Study is evaluating a study drug to see if it may safely and effectively reduce the need for blood transfusions due to myelodysplastic neoplasms/syndromes (MDS)-related anemia.
The study drug is expected to block a protein in the blood that interferes with your body’s ability to make red blood cells.
Before you agree to participate, the study team will review all aspects of the trial with you, including required tests and procedures. If you decide to take part, you will be given a document called an Informed Consent Form that provides, in writing, the trial’s purpose, tests, procedures, benefits, risks, and precautions. You will have the opportunity to ask questions and decide if taking part is right for you.
Please contact a study site near you if you have questions. A research nurse or coordinator can provide more information and answer your questions.
A placebo is an inactive material that looks like the study drug but does not contain any active study drug. The use of a placebo in a trial like this is needed to allow researchers to compare the results in a group that got the trial drug to the results in a group that did not get the trial drug but otherwise followed the same steps and received the same level of care.

Privacy, Stopping Participation, Costs, and Permission

The study teams respect and protect your privacy and will not share your information except as required by law and will store your personal information with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be maintained.
Your participation in a clinical trial is entirely voluntary and you may withdraw at any time. If you decide to withdraw early, you will be asked to notify the study team before doing so. You will be asked to return to the clinic at least once to complete a final visit. With your permission, the study team may contact you periodically for a period of 3 to 5 years after your last dose of study treatment.
There is no charge for participation. All tests and procedures and the study drug related to the clinical trial are provided at no charge.
You will not be paid for taking part in the trial. The study team can inform you about reimbursement for expenses incurred to attend study visits if you are eligible.
Your doctor does not have to give permission for you to participate. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin, ask about your medical history, and keep your doctor up to date about your progress.

About Clinical Trials

A clinical trial, also known as a research study, is a scientific study that evaluates the safety and effectiveness of a study drug. A clinical trial may show that the study drug is better than, as good as, or worse than the standard treatment or inactive placebo (looks like the study drug but contains no active ingredient). Qualified doctors, nurses, and other medical professionals are responsible for conducting the trial.

It is only through the completion of clinical trials that study drugs can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries will provide this approval after a thorough review. Prescription drugs in use today were first proven safe and effective during clinical trials.

Only participants who meet all required eligibility criteria for a clinical trial may take part. The study team at the clinic you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the trial. You may also be asked to provide information from your medical records to help the study team determine whether or not you may be eligible.

A study drug is a drug that is currently being tested and has not been approved by regulatory or health authorities for prescription use.

Reference:

1. Platzbecker U, Fenaux P, Adès L, et al. Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials. Blood. 2019;133(10):1020-1030. doi:10.1182/blood-2018-06-857102

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