Uric Acid and Long-term Outcomes in Chronic Kidney Disease

Completed

• Conditions: Chronic Kidney Disease

• Registration Number: NCT01158911
• Lead Sponsor: Tufts Medical Center

Brief Summary

Patients in the earlier stages of Chronic kidney disease (CKD) are at risk both for the development of end-stage renal disease (ESRD) (define by the requirement for dialysis or kidney transplantation) and development of cardiovascular disease (CVD). Although controversial, there is literature to suggest that uric acid may play a role in the progression of kidney disease and development of cardiovascular disease (CVD). The Modification of Diet in Renal Disease (MDRD) Study was a randomized controlled trial in patients with CKD, which examined the effects of dietary protein restriction and strict blood pressure control on progression of non-diabetic CKD. Extensive data on risk factors for progression of kidney disease and development of CVD are available, as is long term follow up. 838 of the 840 patients who were randomized have uric acid levels measured at baseline. The aims of the present study are to examine the determinants of uric acid in cross sectional analysis at baseline, to determine the association between uric acid and development of ESRD, and the association of uric acid with all-cause and CVD mortality.

Level of kidney function will be a major determinant of uric acid levels independent of other risk factors.

Level of uric acid will be associated with development of ESRD independent of level of kidney function and other risk factors.

Uric Acid levels will be associated with both all-cause and CVD mortality independent of kidney function and other risk factors.

Detailed Description

Not available

Study Timeline

• Status Verified: 2006-10
• Study Start: 2007-02
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-07
• Last Update Submitted: 2010-07-07
• Study First Posted: 2010-07-08
• Last Update Posted: 2010-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 838

Inclusion Criteria

• between 18 and 70 years of age
• with serum creatinine of 1.2 to 7 mg/dl in women and 1.4 to 7 mg/dl in men

Exclusion Criteria

• pregnancy
• Type I diabetes
• insulin dependent type II diabetes
• renal artery stenosis
• proteinuria greater than 10mg/day
• mean arterial pressure greater than 125 mmHg
• prior kidney transplant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kidney Failure

Secondary Outcome Measures

Name	Time	Method
CVD and All-Cause Mortality

Trial Locations

Locations (1)

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States