Chronic Kidney Disease Clinical Trial
Official title:
Does Uric Acid Promote Progression of Kidney Disease and Development of Cardiovascular Disease in Patients With Chronic Kidney Disease?
| NCT number | NCT01158911 |
| Other study ID # | 4530 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | July 6, 2010 |
| Last updated | July 7, 2010 |
| Start date | February 2007 |
| Verified date | October 2006 |
| Source | Tufts Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 838 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Tufts Medical Center | Boston | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Tufts Medical Center | Takeda Pharmaceuticals North America, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Kidney Failure | |||
| Secondary | CVD and All-Cause Mortality |
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