Losartan to Reverse Sickle Nephropathy

Conditions:Renal Impairment / Chronic Kidney Disease, Neurology, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology, Neurology
Age Range:6 - Any
Start Date:February 2012
End Date:December 2015

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A Phase II Trial of Losartan to Reverse Sickle Nephropathy

Sickle cell disease causes kidney damage with increasing age, leading to chronic kidney
disease and renal failure in nearly one third of patients with sickle cell disease.
Currently, there is no treatment for sickle cell related kidney disease.

The purpose of this research study is to see if losartan can help reduce or reverse damage
done to the kidneys of children and adults with Sickle Cell Anemia (SCA) and Sickle Beta-zero
(HbSβ0) Thalassemia.

Inclusion Criteria:

1. Age ≥6 years of age; for no albuminuria (NoA) group age is ≥ 6 years and <21 years of

2. Diagnosis of hemoglobin SS disease or Sβ0 thalassemia by hemoglobin electrophoresis
and/or β-globin gene mapping.

3. Urine osmolality <700 mOsm on first morning urine

4. Written informed consent (and assent, where applicable)

5. Documented urine albumin levels showing either

- NoA:,.UAlb <30mg/g creatinine on a first morning urine

- MiA: UAlb 30-300 mg/g creatinine on a first morning urine or

- MaA: UAlb >300 mg/g creatinine on a first morning urine sample

6. A documented negative serum pregnancy test for females with child bearing potential or
greater than 10 years of age within (prior to) 7 days of starting the study

7. Subjects with child-bearing potential must be willing to use a medically accepted form
of contraception throughout the study.

8. Patients on hydroxyurea who are on a stable (not changing) dose of HU for three months
prior to study entry.

Exclusion Criteria:

1. Patients with Hb SC, SD, Sβ+thal, SE and other sickle hemoglobinopathies, and sickle
trait (AS).

2. Pregnant or lactating females, or females of child-bearing potential that are unable
to use a medically accepted form of contraception throughout the study.

3. Urine creatinine clearance (Clcr) <60 mL/minute/1.73 m2

4. Gross (not microscopic) hematuria. If hematuria has resolved for 2 weeks or more,
patients will be eligible.

5. Hyperkalemia (K≥5.5) at baseline despite a low potassium diet

6. Concurrent condition that predisposes to nephropathy, such as lupus, diabetes, and
hypertension, not controlled with medications..

7. On a renin-angiotensin pathway inhibitor (e.g., captopril, lisinopril, Losartan,
valsartan, etc) for the last two weeks prior to enrollment.

8. Hypersensitivity to Angiotensin II receptor blockers such as losartan, valsartan,

9. Patients on red cell apheresis or ongoing aggressive chronic transfusions (one or more
a month with a goal of HbS < 30%). Patients receiving a simple transfusion for
symptoms during acute event will be eligible, but if they receive a partial or full
exchange transfusion during an acute event, then they will only be eligible after 90

10. Hepatic dysfunction defined as ALT or direct bilirubin > 3X upper limit of normal

11. Chronic therapy with NSAIDS or Cox2 inhibitors

12. On another interventional trial. May be eligible two weeks after completion of another
interventional study.

13. Any condition that interferes with the ability of the patient to understand or comply
with the treatment plan and follow up.

14. A serious mental or physical illness or a major disease (cardiac, renal, hepatic,
neurological, endocrine, metabolic, pulmonary function or psychiatric), which in the
opinion of the investigator would compromise participation in the study.

15. Unable to take oral medications.

16. HIV confirmed positive.

17. Chronic therapy with steroids. May be eligible after three weeks of completing steroid

18. Patients on lithium will be excluded
We found this trial at
1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
Akron, OH
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
Cincinnati, OH
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
Columbus, OH
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Bethesda, Maryland 20892
Bethesda, MD
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
Chicago, IL
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
Cincinnati, OH
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Dallas, Texas 75390
Dallas, TX
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
Houston, TX
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
Louisville, KY
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