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NephropathyPhase 2NCT01479439

Losartan to Reverse Sickle Nephropathy

A Phase 2 study testing Losartan in people with Nephropathy and Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Nephropathy, Sickle Cell Anemia
What is being tested?
Losartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
9 sitesUnited States
Study dates
Feb 2012to Dec 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥6 years of age; for no albuminuria (NoA) group age is ≥ 6 years and <21 years of age
  • Diagnosis of hemoglobin SS disease or Sβ0 thalassemia by hemoglobin electrophoresis and/or β-globin gene mapping.
  • Urine osmolality <700 mOsm (milliosmoles) on first morning urine
  • Written informed consent (and assent, where applicable)
  • Documented urine albumin to creatinine ratio (UACR) showing either
  • NoA: UACR <30mg/g creatinine on a first morning urine
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  • MiA: UACR 30-300 mg/g creatinine on a first morning urine or
  • MaA: UACR >300 mg/g creatinine on a first morning urine sample
  • 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 medication.
  • Subjects with child-bearing potential must be willing to use a medically accepted form of contraception throughout the study.
  • Patients on hydroxyurea (HU) who are on a stable (not changing) dose of HU for three months prior to study entry.

Who cannot join

  • Patients with Hb SC, SD, Sβ+thal, SE and other sickle hemoglobinopathies, and sickle trait (AS).
  • Pregnant or lactating females, or females of child-bearing potential that are unable to use a medically accepted form of contraception throughout the study.
  • Urine creatinine clearance (Clcr) <60 mL/minute/1.73 m2
  • Gross (not microscopic) hematuria. If hematuria has resolved for 2 weeks or more, patients will be eligible.
  • Hyperkalemia (K≥5.5) at baseline despite a low potassium diet
  • Concurrent condition that predisposes to nephropathy, such as lupus, diabetes, and hypertension, not controlled with medications..
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  • On a renin-angiotensin pathway inhibitor (e.g., captopril, lisinopril, Losartan, valsartan, etc) for the last two weeks prior to enrollment.
  • Hypersensitivity to Angiotensin II receptor blockers such as losartan, valsartan, telmisartan.
  • 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 days.
  • Hepatic dysfunction defined as ALT (alanine aminotransferase) or direct bilirubin > 3-times upper limit of normal (ULN).
  • Chronic therapy with NSAIDS or Cox2 inhibitors
  • On another interventional trial. May be eligible two weeks after completion of another interventional study.
  • Any condition that interferes with the ability of the patient to understand or comply with the treatment plan and follow up.
  • 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.
  • Unable to take oral medications.
  • HIV confirmed positive.
  • Chronic therapy with steroids. May be eligible after three weeks of completing steroid therapy.
  • Patients on lithium will be excluded

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Akron Children's Hospital

    Akron, Ohio, 44308

  • NHLBI

    Bethesda, Maryland, 20892

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • University of Cincinnati

    Cincinnati, Ohio, 45229

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Texas Children's Hospital

    Houston, Texas, 77030

  • University of Louisville

    Louisville, Kentucky, 40201

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Losartan
Medical subject headings
Kidney Diseases, Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LosartanDrug

    Form: suspension, tablet. Dosage \& frequency: age 6-16 = 0.7mg/kg once daily; age >16 = 50mg once daily. Duration: 6 months

Study groups in NCT01479439
Study groupRoleWhat they receive
Sickle cell diseaseExperimentalThe 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.
Receives: Drug: Losartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Categorical Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline

    Number of participants who have a ≥25% reduction in urinary albumin-to-creatinine ratio (UACR) from baseline to 6 months. This is a categorical outcome (yes/no).

    We hypothesized and pre-specified that ≥30% of the subjects in the microalbuminuria group would meet this outcome.

    Measured: Baseline and 6 months

Secondary outcomes (2)

  1. Change in UACR

    Fold-change in UACR from baseline

    Measured: Baseline and 6 months

  2. Change in Creatinine Clearance

    Fold-change in creatinine clearance by 24h urine collection (GFR-CrCl) from baseline

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionNov 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01479439
Sponsor's protocol ID
2010-3070
Status last verified
Sep 2020
First submitted
16 Nov 2011
Last updated
29 Sep 2020
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Quinn CT, Saraf SL, Gordeuk VR, Fitzhugh CD, Creary SE, Bodas P, George A, Raj AB, Nero AC, Terrell CE, McCord L, Lane A, Ackerman HC, Yang Y, Niss O, Taylor MD, Devarajan P, Malik P. Losartan for the nephropathy of sickle cell anemia: A phase-2, multicenter trial. Am J Hematol. 2017 Sep;92(9):E520-E528. doi: 10.1002/ajh.24810. Epub 2017 Jul 19.

    PubMed 28589652

  • Eskandari N, Pappano E, Ruiz MA, Mahmud N, Ren G, Ivy Z, Gaitonde S, Gordeuk VR, Gladwin MT, Malik P, Quinn CT, Saraf SL. Renin-angiotensin-aldosterone system inhibition exacerbates anemia in sickle cell disease. Blood. 2026 Aug 6;148(6):783-788. doi: 10.1182/blood.2026033813.

    PubMed 42224366

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Losartan in people with Nephropathy and Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Categorical Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01479439, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.

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