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OpenTrials
Completed

NCT Number: NCT01158911

Uric Acid and Long-term Outcomes in Chronic Kidney Disease

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Kidney Failure

Secondary outcomes

  1. CVD and All-Cause Mortality

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Official study title

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

Important dates

Study start
2007
First posted
Jul 8, 2010
Registry last updated
Jul 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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