A Research Study for Children and Adults who have Kidney Damage Caused by Sickle Cell Disease

What is the purpose of this study?

This is a research study to find out if a medication, called losartan, can help reduce or reverse sickle cell-related kidney disease.

Who can participate?

Children at least 6 years old and adults who have a minor or major form of kidney damage caused by sickle cell anemia (SS disease) and sickle beta-zero thalassemia may be eligible to participate.

Ages

  • 6  years old and above

Conditions

  • Hematology - Sickle Cell and Hemoglobin

What is involved?

Participation in the study involves about eleven visits over a period of about six months. All study participants will receive losartan medication for a total of six months and will be required to maintain a medication diary for the duration of the study.

Other tests and procedures that will be performed include, but are not limited to:

  • Health and medication history
  • Physical exams, including height and weight, temperature, pulse, and blood pressure measurements
  • Blood draws to check kidney function, blood cells, and blood levels
  • Urine tests to check for protein levels
  • EKG (electrocardiogram) and ECHO (ultrasound of the heart) to check heart function
  • Walking tests to assess heart and lung function

A detailed list of tests and procedures will be provided to those interested in knowing more about this study.

What are the benefits?

Participants may receive a direct medical benefit by taking part in the study, including the possibility of reduced or reversed kidney damage. In addition, information from the study may benefit other patients with sickle cell disease in the future.

Will I get all the facts about the study?

Those interested in participating will be given a consent form that thoroughly explains all of the details of the study. The consent form covers all of the procedures, the potential risks and benefits, who to contact with questions or concerns and more. A member of the study staff will review the consent form with participants to ensure all questions are answered. Study procedures will not begin until the participant has signed this consent form.

What are the risks and discomforts of the study?

There are some potential side effects associated with taking losartan and minor discomforts associated with the study procedures. A complete list of risks and benefits will be provided in the consent form to those interested in learning more about the study.

Do participants receive pay, compensation or reimbursement?

Participants may receive up to $520 for time and travel.

Who should I contact for more information?

Clinical Research Nurse Coordinator

Sickle Cell Research Office
513-636-6770

Division of Hematology
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue
Cincinnati, OH 45229-3039

sicklecell@cchmc.org

Principal Investigator

Punam Malik, MD
Principal Investigator
Program Leader, Hematology and Gene Therapy Program, Division of Hematology Cincinnati Children’s Hospital Medical Center