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Uric Acid and Long-term Outcomes in Chronic Kidney Disease

Does Uric Acid Promote Progression of Kidney Disease and Development of Cardiovascular Disease in Patients With Chronic Kidney Disease?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01158911
Enrollment
838
Registered
2010-07-08
Start date
2007-02-28
Completion date
Unknown
Last updated
2010-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

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

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.

Interventions

None listed

Sponsors

Takeda Pharmaceuticals North America, Inc.
CollaboratorINDUSTRY
Tufts Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Kidney Failure

Secondary

MeasureTime frame
CVD and All-Cause Mortality

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026