Uric Acid and the Endothelium is CKD
This study is currently recruiting participants.
Verified September 2012 by University of Colorado, Denver
Sponsor:
University of Colorado, Denver
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01228903
First received: October 25, 2010
Last updated: September 25, 2012
Last verified: September 2012
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Purpose
This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease
| Condition | Intervention |
|---|---|
|
Kidney Disease |
Drug: Allopurinol Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Is Uric Acid a Mediator of Endothelial Dysfunction in Patients With Chronic Kidney Disease? |
Resource links provided by NLM:
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- Endothelial Dependent Dilation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Endothelial Dependent Dilation measured by Flow Mediated Dilation
Secondary Outcome Measures:
- Systemic inflammation and oxidative stress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Inflammation will be measured by plasma levels of the following: hs- CRP, interleukin 6 (IL-6), and monocyte chemotactic protein-1 (MCP-1). Oxidized low density lipoprotein cholesterol (oxLDL), asymmetric dimethylarginine (ADMA), and 8-isoprostanes, as markers of oxidative stress.
- Inflammation and oxidative stress in the endothelial cells [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Actual measurements: intercellular adhesion molecule (ICAM-1) and nuclear factor kappa-B (NFkappa-B p65), nitrotyrosine, Nox4-containing NAD(P)H oxidase complexes, and endothelial nitric oxide synthase (eNOS).
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control
Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.
|
Other: Placebo
Placebo tablets with no active ingredient
|
|
Active Comparator: Allopurinol
Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.
|
Drug: Allopurinol
Xanthine oxidase inhibitor- effective at lowering uric acid levels.
Other Name: Zyloprim, Allohexal, Allosig, Milurit, Alloril, Progout, Zyloric.
|
Detailed Description:
The purpose of the study is to understand the effect of lowering serum uric acid levels on vascular function in individuals with chronic kidney disease by comparing the effects of:
1) Allopurinol therapy and 2) Placebo.
Patients will receive: 3 month study drug (either allopurinol or placebo), with assessment of serum uric acid levels and vascular function.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228903
Contacts
| Contact: Diana I Jalal, MD | 3037244867 | diana.jalal@ucdenver.edu |
| Contact: Michel Chonchol, MD | 3033996997 | michel.chonchol@ucdenver.edu |
Locations
| United States, Colorado | |
| University of Colorado at Denver | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Diana I Jalal, MD 303-724-4867 diana.jalal@ucdenver.edu | |
| Contact: Michel Chonchol, MD 3033996997 michel.chonchol@ucdenver.edu | |
| Principal Investigator: Diana I Jalal, MD | |
| Sub-Investigator: Michel Chonchol, MD | |
| Sub-Investigator: Richard J Johnson, MD | |
| Sub-Investigator: Tomas Berl, MD | |
| Sub-Investigator: Kim McFann, PhD | |
Sponsors and Collaborators
University of Colorado, Denver
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01228903 History of Changes |
| Other Study ID Numbers: | 10-0625, K23DK088833 |
| Study First Received: | October 25, 2010 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Colorado, Denver:
|
uric acid kidney disease endothelial dysfunction |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency Allopurinol Uric Acid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Gout Suppressants Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013