The Role of Endothelin-1 in Sickle Cell Disease

Completed · Phase 1 · Has a placebo group

Conditions studied: Sickle Cell Anemia

In brief

The primary goal of the study is to determine the safety and tolerability of ambrisentan. It is also expected that ambrisentan will improve blood flow in the lungs, decrease inflammation, and reduce pain in sickle cell patients. An additional goal is to evaluate the use of select biomarkers in evaluating sickle nephropathy.

Key facts

Study ID

NCT02712346

Run by

Augusta University

People needed

26

Starts

2015-09-01

Expected to finish

2019-11-30

Last updated by the study team

2020-04-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• SS or Sβo-thalassemia
• Age 18-65 years
• Microalbuminuria (24-hour albumin 150-300 mg) or macroalbuminuria (24-hour albumin >300 mq) OR random urine albumin-creatinine ratio (MA Random) ≥ 30 µg/ mg creatinine
• Subjects can have Stage 1, II, or III chronic kidney disease (CKD)
• Subjects can be on hydroxyurea, ACE inhibitors (ACEi), or angiotensin receptor blockers (ARBs) for a period of 3 months or greater
• Females of child bearing potential must agree to use two forms of birth control with one being a barrier method; abstinence is an acceptable form of birth control

You may not qualify if…

• Other genotypes of SCD
• History of renal transplant
• Chronic kidney disease (Stage IV and V including patients on hemo dialysis or peritoneal dialysis)
• Patients on chronic transfusion therapy
• Uncontrolled/poorly controlled hypertension or history of hypertension pre-dating proteinuria or
• Known history of HIV, Hepatitis C, and/or diabetes
• Peripheral edema
• History of congestive heart failure or pulmonary edema
• Recent history of coronary artery disease
• Pregnant or breast feeding
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >3-fold upper limit of normal
• Albumin <2.5 gm/dl
• Hemoglobin < 6 gm/dL
• History of non-compliance with medications and clinic visits; or Inability to give informed consent; or Patient deemed ineligible or unsuitable in the judgment of investigators

Where it is running

• Augusta University — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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