Study of Heart and Renal ProtectionEstudio de Protección Cardíaca y Renal - SHARP

Phase 1

• Conditions: Chronic Kidney Disease

• Registration Number: EUCTR2004-001156-37-ES
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-10-04
• Study Completion: 2010-08-19
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9000

Inclusion Criteria

•History of Chronic Kidney Disease (CKD): either patients who are pre-dialysis (with a plasma or serum creatinine greater than or equal to 150 micromol/l [greater than or equal to 1.7 mg/dl] in men, or greater than or equal to 130 micromol/l [greater than or equal to 1.5 mg/dl] in women); or patients on dialysis (haemodialysis or peritoneal dialysis)
•Men or women aged greater than or equal to 40 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Definite history of myocardial infarction or coronary revascularisation procedure
•Functioning renal transplant, or living donor-related transplant planned
•Less than 2 months since presentation as an acute uraemic emergency (but may be entered later, if appropriate);
•Definite history of chronic liver disease, or abnormal liver function (i.e. alanine aminotransferase (ALT) > 1.5 x upper limit of normal (ULN) or, if ALT not available, aspartate aminotransferase (AST) > 1.5 x ULN). (Note: Patients with a history of hepatitis are eligible provided these limits are not exceeded);
•Evidence of active inflammatory muscle disease (e.g. dermatomyositis, polymyositis), or creatine kinase (CK) >3 x ULN;
•Definite previous adverse reaction to a statin or to ezetimibe
•Concurrent treatment with a contraindicated drug (Note: Patients who are temporarily taking such drugs may be re-screened for participation in the study when they discontinue them, if appropriate.) These contraindicated drugs include:
-HMG-CoA reductase inhibitor (statin”)
-fibric acid derivative (fibrate”)
-nicotinic acid
-macrolide antibiotic (erythromycin, clarithromycin)
-systemic use of imidazole or triazole antifungals (e.g. itraconazole, ketoconazole)
-protease-inhibitors (e.g. antiretroviral drugs for HIV infection)
-nefazodone
-ciclosporin
•Child-bearing potential (i.e. premenopausal woman who is not using a reliable method of contraception.)
•Known to be poorly compliant with clinic visits or prescribed medication
•Medical history that might limit the individual’s ability to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified