N/A
N=80
Uric Acid and the Endothelium in CKD
Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT01228903 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Feb 2017
Primary outcome: Primary: Change in Endothelial Dependent Dilation From Baseline to Week 12 — 0.2; 0.9 % change — p=0.47
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Allopurinol (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Endothelial Dependent Dilation From Baseline to Week 12 |
0.2; 0.9 | 0.47 |
| SECONDARY Change in C-reactive Protein From Baseline to Week 12 |
0.7; 00.42 | — |
| SECONDARY Change in Serum Interleukin-6 From Baseline to Week 12 |
0.15; 0.37 | — |
| SECONDARY Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12 |
-4.7; 3.6 | — |
| SECONDARY Change in Oxidized Low Density Lipoprotein From Baseline to Week 12 |
-0.08; -2.97 | — |
Summary
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease
Eligibility Criteria
Inclusion Criteria
- Individuals with moderate chronic kidney disease (CKD stage III) with estimated glomerular filtration rates between 30-60 mL/min/ 1.73m2
- Elevated uric acid levels
- Age range: more than 18 years old
- Ability to give informed consent
- Albumin > 3.0 g/dL
- BMI < 40 kg/m2
Exclusion Criteria
- Life expectancy < 1.0 years
- Expected to undergo living related kidney transplant in 6 months
- Pregnant, breast feeding, or unwilling to use adequate birth control
- History of severe liver disease
- History of severe congestive heart failure
- History of hospitalizations within 3 months
- Active infection, on antibiotics
- History of Warfarin Use or other medications that are contraindicated with allopurinol
- Uncontrolled hypertension
- History of acute gout on Allopurinol
- History of adverse reaction to Allopurinol
- Immunosuppressive therapy within the last 1 yr
Data sourced from ClinicalTrials.gov (NCT01228903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.