CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 9,438 enrolled
Drug / intervention
Simvastatin 20 mg +2 moredrug
Likely dose
Simvastatin 20 mg once daily plus ezetimibe 10 mg once dailyAI-extracted
Key inclusion· 2
  • History of chronic kidney disease: either pre-dialysis with serum creatinine ≥150 micromol/L (≥1.7 mg/dL) in men or ≥130 micromol/L (≥1.5 mg/dL) in women, OR currently on dialysis (hemodialysis or peritoneal dialysis)
  • Age ≥40 years
Key exclusion· 10
  • History of myocardial infarction or coronary revascularization procedure
  • Functioning renal transplant or living donor-related transplant planned
  • Less than 2 months since acute uraemic emergency presentation
  • Chronic liver disease or abnormal liver function (ALT >1.5× ULN or if unavailable, AST >1.5× ULN)

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

Search/NCT00125593
NCT00125593Phase 4Completed

Study of Heart and Renal Protection (SHARP): The Effects of Lowering LDL-cholesterol With Simvastatin 20mg Plus Ezetimibe 10mg in Patients With Chronic Kidney Disease: a Randomized Placebo-controlled Trial

University of Oxford·interventional·Posted Aug 1, 2005·Updated Feb 1, 2012

In Brief

A Phase 4 clinical trial evaluating Simvastatin 20 mg, Ezetimibe 10mg, and 1 other intervention for Kidney Disease, Chronic. Completed, enrolled 9,438 participants across 1 site.

Detailed Summary

The chief aim of SHARP was to determine whether lowering blood LDL cholesterol with simvastatin (20mg) plus ezetimibe (10mg) daily could safely reduce the risk of coronary heart disease, non-hemorrhagic stroke and the need for revascularization procedures in patients with chronic kidney disease (CKD). It also aimed to assess whether lowering LDL cholesterol reduced the rate of loss of renal function in people with CKD who had not commenced dialysis treatment.

Study Details

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

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 1, 2005
Enrollment StartJun 1, 2003
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.9 years ago

Interventions

Simvastatin 20 mgdrug

Once daily

Ezetimibe 10mgdrug

Once daily

Placebodrug

Once daily