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| autoid | 14 |
| crg_id | CRG060500006 |
| titleoftrial | Second United Kingdom Heart and Renal Protection study |
| acronymnoftrial | UK-HARP-II |
| website | |
| identificationno | Sponsor\'s Protocol No. CTSUSHARP1 |
| leadprefix | Dr |
| leadsurname | Baigent |
| leadgivennames | Colin |
| leadposition | Reader in Clinical Epidemiology |
| leaddepartment | Clinical Trial Service Unit |
| leadorganisation | University of Oxford |
| leadaddress | Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford. OX3 7LF, UK |
| leademail | colin.baigent@ctsu.ox.ac.uk |
| leadphone | +44 1865 743743 |
| leadfax | +44 1865 743985 |
| leadsuffix | |
| contactprefix | Dr |
| contactsurname | Landray |
| contactgivennames | Martin J |
| contactposition | Senior Clinical Lecturer |
| contactdepartment | Clinical Trial Service Unit |
| contactorganisation | University of Oxford |
| contactaddress | Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford. OX3 7LF, UK |
| contactemail | martin.landray@ctsu.ox.ac.uk |
| contactphone | +44 1865 743743 |
| contactfax | +44 1865 743985 |
| funding | industry |
| otherfunding | |
| fundingnameofsponsors | University of Oxford |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | yes |
| blinding_investigators | yes |
| blinding_outcomes | yes |
| blinding_analysts | yes |
| proposedstart | |
| actualstart | 03/2002 |
| proposedcompletiondate | |
| actualcompletiondate | 02/2003 |
| multi_center_study | yes |
| numberofcentres | 8 |
| multi_national_study | no |
| countrycentres | United Kingdom |
| researchquestion | This study assessed the biochemical efficacy, safety and tolerability of adding ezetimibe 10 mg daily to simvastatin 20mg daily among patients with chronic kidney disease. |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | Chronic kidney disease |
| intervention1 | ezetimibe 10 mg daily + simvastatin 20 mg daily |
| intervention2 | ezetimibe 10 mg daily + placebo simvastatin daily |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 18 or over |
| totalrecruitment | 203 |
| inclusion | Men or women aged 18 or over were eligible if: (i) they were a pre-dialysis patient with the most recent serum or plasma creatinine ≥150 mol/l (1.7 mg/dl), a haemodialysis patient, or a peritoneal dialysis patient; and (ii) their own nephrologist did not consider that there was a definite indication for cholesterol-lowering therapy or a definite contraindication to either simvastatin or ezetimibe. |
| exclusion | Patients were not to be randomized for the following reasons: history of acute uraemic emergency within the preceding 2 months; history of chronic liver disease or baseline alanine transaminase [ALT] ≥1.5 x upper limit of normal (ULN); active muscle disease (i.e. dermatomyositis, polymyositis or polymyalgia rheumatica), or creatine kinase [CK] >3 x ULN; previous adverse reaction to a statin or to ezetimibe; current treatment with a contraindicated drug (i.e. non-study statin, fibrate; niacin; macrolide antibiotic [erythromycin or clarithromycin]; systemic imidazole or triazole antifungal; nefazodone; ciclosporin; tacrolimus); child-bearing potential (if female) in the absence of a reliable method of contraception; a life-threatening condition other than chronic renal failure or vascular disease; frequent non-attendance at clinics or known non-compliance with drug treatments. |
| primaryoutcomes | The principal analyses will be of: 1. tolerability: in terms of any excess of minor symptoms 2. safety: in terms of the frequency of abnormal liver enzymes or creatine kinase (CK>10xULN); differences in the mean concentration of plasma creatinine, and in the frequency of an increase of creatinine of 20% or more since randomisation; differences in concentrations of calcium, phosphate, vitamin A and vitamin E at 1, 3 and 6 months, and 3. efficacy: in terms of differences in lipid profile (total cholesterol, LDL-cholesterol and HDL-cholesterol, triglycerides, apolipoproteins AI and B). |
| secondaryoutcomes | |
| reference | 1. Presented in abstract form at the Scientific Sessions of the American Heart Association, Orlando, Florida, 10th November 2003. 2. Landray M. Baigent C. Leaper C. Adu D. Altmann P. Armitage J. Ball S. Baxter A. Blackwell L. Cairns HS. Carr S. Collins R. Kourellias K. Rogerson M. Scoble JE. Tomson CR. Warwick G. Wheeler DC. The second United Kingdom Heart and Renal Protection (UK-HARP-II) Study: a randomized controlled study of the biochemical safety and efficacy of adding ezetimibe to simvastatin as initial therapy among patients with CKD. American Journal of Kidney Diseases. 47(3):385-95, 2006 Mar. [added by Gail Higgins 21/08/2007] |