CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Atorvastatin +1 moredrug
Likely dose
Atorvastatin 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01732718
NCT01732718Phase 2Completed

The Effect of Atorvastatin on Endothelial Dysfunction and Albuminuria in Sickle Cell Disease (in the Grant Entitled: Endothelial Dysfunction in the Pathogenesis of Sickle Cell Nephropathy)

University of North Carolina, Chapel Hill·interventional·Posted Nov 26, 2012·Updated Mar 18, 2020

In Brief

A Phase 2 clinical trial evaluating Atorvastatin and Placebo for Sickle Cell Disease and Sickle Cell Nephropathy. Completed, enrolled 13 participants across 1 site.

Detailed Summary

The purpose of this research study is to learn about the effect of the drug, atorvastatin, on blood vessels in patients with sickle cell disease. The primary hypothesis is that endothelial dysfunction is an important contributor to the pathophysiology of albuminuria in SCD. The investigators propose that atorvastatin will improve endothelial dysfunction, decrease levels of soluble fms-like tyrosine kinase-1 (sFLT-1), and decrease albuminuria in SCD patients. Participants will be individuals with sickle cell disease, age 18 to 60, who have some degree of albuminuria. A total of 19 subjects, males and females, will be enrolled. The study is made up of Screening, Treatment, and Follow Up phases and has a cross-over design. After patients are screened for eligibility, they will be randomized to receive atorvastatin or placebo in the initial six-week treatment period. When that is complete, there will be a four-week washout period before they begin another six-week treatment period. In the second treatment period, they "cross-over" to the other treatment arm. Four weeks after the end of the second treatment period, follow-up safety assessments will be done.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 26, 2012
Enrollment StartSep 1, 2013
Primary CompletionJan 9, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 13.6 years ago

Interventions

Atorvastatindrug

40 mg tablet by mouth daily for 6 weeks

Placebodrug

Matching placebo tablet by mouth daily for 6 weeks