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Uric Acid and Long-term Outcomes in Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01158911
Recruitment Status : Completed
First Posted : July 8, 2010
Last Update Posted : July 8, 2010
Takeda Pharmaceuticals North America, Inc.
Information provided by:
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.

Condition or disease
Chronic Kidney Disease

Study Type : Observational
Actual Enrollment : 838 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Does Uric Acid Promote Progression of Kidney Disease and Development of Cardiovascular Disease in Patients With Chronic Kidney Disease?
Study Start Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Uric Acid
U.S. FDA Resources

non-diabetic Chronic Kidney disease

Primary Outcome Measures :
  1. Kidney Failure

Secondary Outcome Measures :
  1. CVD and All-Cause Mortality

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01158911

United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Takeda Pharmaceuticals North America, Inc.

Responsible Party: Mark Sarnak, MD, Tufts Medical Center Identifier: NCT01158911     History of Changes
Other Study ID Numbers: 4530
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: July 8, 2010
Last Verified: October 2006

Keywords provided by Tufts Medical Center:
kidney disease
uric acid
kidney failure
Uric Acid levels in patients with Chronic Kidney Disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Uric Acid
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs