Phase 2 N=36 Treatment

Losartan to Reverse Sickle Nephropathy

Nephropathy · Sickle Cell Anemia

Bottom Line

View on ClinicalTrials.gov: NCT01479439 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Categorical Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline — 1; 7; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Losartan (Drug)
Age: Pediatric, Adult, Older Adult · 6+ yrs
Sex: All
Sponsor: Children's Hospital Medical Center, Cincinnati
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Categorical Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline	1; 7; 5	—
SECONDARY Change in UACR	0.08; -0.46; -0.74	—
SECONDARY Change in Creatinine Clearance	0.06; 0.12; 0.05	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01479439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.