Uric Acid and Long-term Outcomes in Chronic Kidney Disease

NCT01158911 | Completed

• 1 other identifier: 4530
• Study Type: observational
• Target: 838
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

kidney disease; uric acid; outcomes; cardiovascular; mortality; kidney failure; Uric Acid levels in patients with Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Kidney Failure

Secondary Outcomes (1)

• CVD and All-Cause Mortality

Study Arms (1)

non-diabetic Chronic Kidney disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

838 participants of the randomized arm of the Modification of Diet in Renal Disaese (MDRD) Study conducted between 1989-1993

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Takeda Pharmaceuticals North America, Inc.: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases; Renal Insufficiency

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 8, 2010
• Study Start: February 1, 2007
• Last Updated: July 8, 2010

Record last verified: 2006-10

Locations

US (1)