Uric Acid and Long-term Outcomes in Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01158911
First received: July 6, 2010
Last updated: July 7, 2010
Last verified: October 2006
  Purpose

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
Chronic Kidney Disease

Study Type: Observational
Study Design: 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?

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Kidney Failure

Secondary Outcome Measures:
  • CVD and All-Cause Mortality

Enrollment: 838
Study Start Date: February 2007
Groups/Cohorts
non-diabetic Chronic Kidney disease

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158911

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

No publications provided

Responsible Party: Mark Sarnak, MD, Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01158911     History of Changes
Other Study ID Numbers: 4530
Study First Received: July 6, 2010
Last Updated: July 7, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014