Overview

This trial is active, not recruiting.

Condition sickle cell disease
Sponsor Emory University
Start date December 2012
End date December 2016
Trial size 40 participants
Trial identifier NCT01989078, IRB00056125, SCD Losartan

Summary

Sickle cell nephropathy (SCN) is a progressive complication of sickle cell disease (SCD) that begins in childhood and results in renal (kidney) failure and early mortality in nearly 12% of adults with hemoglobin SS (HbSS). The potential for prevention and reversal of kidney damage in SCD is not known. Albuminuria is a commonly used biomarker of glomerular damage; however the correlations of albuminuria with specific measurements of glomerular function and pathophysiology have not been determined. The investigators hypothesize that in patients with persistent albuminuria despite treatment of SCD with hydroxyurea, losartan will reverse kidney dysfunction in early stage nephropathy and ameliorate progressive kidney dysfunction in more advanced nephropathy. The primary aim is to study the acute and longer-term effects of losartan (study drug) on specific glomerular functions in children and adults with SCD who have persistent albuminuria. Research glomerular function tests will be done at study entry (prior to losartan), 1 month, and 1 year after starting losartan therapy. In addition, subjects are seen each month in clinic and assessed by their regular clinical team. The second aim is to assess the correlation of changes in albuminuria after 1 month of losartan with changes in direct measurements of glomerular function at 12 months, thus determining if the magnitude of the initial decrease in albuminuria in response to losartan predicts sustained improvements in renal function.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
patients taking losartan

Primary Outcomes

Measure
Effects of Losartan
time frame: 12 months after last enrollment

Secondary Outcomes

Measure
chronic angiotensin blockade
time frame: 12 months after last enrollment

Eligibility Criteria

Male or female participants at least 10 years old.

Inclusion Criteria: - SCD genotype HbSS or HbS/beta-0-thalassemia - Age greater than or equal to 10 years old - Urinary albumin/creatinine ratio (ACR) greater than or equal to 30 mg/gram creatinine on greater than or equal to 2 occasions separated by one month or more - current treatment with hydroxyurea and a sustained hematologic response for 6 months or more prior to enrollment Exclusion Criteria: - end-stage renal failure - known co-existent medical conditions that could affect the kidneys - chronic therapy with non-steroidal anti-inflammatory drugs - females who are pregnant - pre-existing hperkalemia - current chronic transfusion therapy

Additional Information

Official title Losartan Treatment for Sickle Cell Chronic Kidney Disease
Principal investigator Marianne Yee, MD
Description Sickle cell nephropathy (SCN) is a progressive complication of sickle cell disease (SCD) that begins in childhood and results in renal (kidney) failure and early mortality in nearly 12% of adults with hemoglobin SS (HbSS). The potential for prevention and reversal of kidney damage in SCD is not known. Albuminuria is a commonly used biomarker of glomerular damage; however the correlations of albuminuria with specific measurements of glomerular function and pathophysiology have not been determined. We hypothesize that in patients with persistent albuminuria despite treatment of SCD with hydroxyurea, losartan will reverse kidney dysfunction in early stage nephropathy and ameliorate progressive kidney dysfunction in more advanced nephropathy. The primary aim is to study the acute and longer-term effects of losartan (study drug) on renal function in children and adults with SCD who have persistent albuminuria. The renal function tests (research tests) will be done at study entry (prior to losartan), 1 month, and 1 year after starting losartan therapy. In addition, subjects are seen each month in clinic and assessed by their regular clinical team. The second aim is to assess the correlation of changes in albuminuria after 1 month of losartan with changes in direct measurements of renal function at 12 months, thus determining if the magnitude of the initial decrease in albuminuria in response to losartan predicts sustained improvements in renal function. Losartan is an FDA-approved drug to treat blood pressure to protect the kidneys in people who have diseases like diabetes and blood pressure. It is not specifically labeled for use in sickle cell disease. Thirty subjects, at least 10 years old, will be enrolled from Children's Healthcare of Atlanta (pediatric subjects) or Grady Memorial Hospital (adult subjects). Subjects are in the study about 1 year. Accrual is expected to take 2 years. Study is funded for 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Emory University.