Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Vanderbilt University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Vanderbilt University
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00732069
First received: August 6, 2008
Last updated: October 21, 2010
Last verified: October 2010
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Purpose
Little is known about how some drugs affect inflammation or clotting factors in people receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they do in people not undergoing hemodialysis or whether they could increase the risk of heart problems. The purpose of the study is to measure certain chemicals in the blood and see how those chemicals may change during hemodialysis when certain drugs are given.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Dialysis Hemodialysis |
Drug: ramipril Drug: valsartan Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 2 |
Resource links provided by NLM:
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- To compare the effect of ACE inhibition or AT1 receptor blockade versus placebo on the fibrinolytic, oxidative stress and inflammatory response to hemodialysis [ Time Frame: end of each study ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To compare the effect of ACE inhibition versus AT1 receptor blockade on the fibrinolytic, oxidative stress and inflammatory response to hemodialysis [ Time Frame: end of each study ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 18 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan
|
Drug: ramipril
After a washout period, subject will undertake 3 study periods with one of the three treatments: Ramipril initiated at 2.5 mg/d for 2 days followed by 5 mg for a total of nine days
Other Name: Altace
|
|
Active Comparator: 2
After a three week washout period, each subject will be randomized to receive one of the three treatments, placebo, ramipril or valsartan
|
Drug: valsartan
After a three week washout period, each subject will undertake 3 study periods with one of three treatment: Valsartan initiated at 80 mg/d for 2 days followed by 160 mg/d for a total of 9 days
Other Name: Diovan
|
|
Placebo Comparator: 3
After a three week washout period, each subject will undertake 3 study periods with one of the three treatments, placebo, ramipril or valsartan
|
Drug: Placebo
After a three week washout period, subject will undertake 3 study periods with one of three treatments: Placebo (inactive pill) for nine days.
Other Name: Placebo
|
Detailed Description:
- Cardiovascular disease in the leading cause of death in patients with chronic kidney disease undergoing hemodialysis.
- Traditional risk factors do not adequately predict cardiovascular morbidity and mortality in patients with chronic kidney disease.
- Increased oxidative stress, inflammation and impaired fibrinolysis contribute to cardiovascular risk in chronic kidney disease patients undergoing hemodialysis.
- Activation of the RAAS may contribute to oxidative stress and inflammation in individuals with chronic kidney disease
- Activation of the kallikrein-kinin system during hemodialysis may increase fibrinolysis but may also contribute to inflammation in chronic kidney disease
- Despite data from clinical trials demonstrating that ARBs and ACE inhibitors decrease cardiovascular mortality, delay progression to cardiovascular disease and decrease the incidence of diabetes in the general population little is known about the impact of these agents on cardiovascular morbidity and mortality in patients with end- stage renal disease (ESRD) undergoing hemodialysis
- ACE inhibitors and ARBS differ in their mechanisms of action and their effects on inflammatory biomarkers
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 years or older
- On thrice-weekly chronic hemodialysis for at least 6 months
- Clinically stable, adequately dialyzed (single-pool Kt/V> 1.2) thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study
Exclusion Criteria:
- Body mass index > 35 mg/kg
- History of functional transplant less than 6 months prior to study
- Use of anti-inflammatory medications other than aspirin < 325 mg/d
- History of active connective tissue disease
- History of acute infectious disease within one month prior to study
- AIDS (HIV seropositivity is not an exclusion criteria)
- History of myocardial infarction or cerebrovascular event within 3 months
- Advanced liver disease
- Gastrointestinal dysfunction requiring parental nutrition
- Active malignancy excluding basal cell carcinoma of the skin
- History of ACE inhibitor-associated cough or angioedema
- Ejection fraction less than 40%
- Inability to discontinue ACE inhibitor or ARB
- Predialysis potassium repeatedly higher than 5.5 mmol/L (confirmed on a repeated blood draw)
- Anticipated live donor kidney transplant
- Use of vitamin E >60 IU/d or vitamin C >500 mg/d
- Pregnancy, breast-feeding or child-bearing potential
- History of poor adherence to hemodialysis or medical regimen
- Inability to provide consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732069
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37323 | |
Sponsors and Collaborators
Vanderbilt University
Investigators
| Principal Investigator: | Nancy J Brown, MD | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | Nancy J. Brown, MD, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00732069 History of Changes |
| Other Study ID Numbers: | Fibrinolysis in Dialysis, R01 HL065193-08A2 |
| Study First Received: | August 6, 2008 |
| Last Updated: | October 21, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
hemodialysis oxidative stress inflammation kallikrein-kinin angiotensin receptor blockade |
angiotensin converting enzyme inhibition RAAS fibrinolysis endothelial dysfunction |
Additional relevant MeSH terms:
|
Inflammation Pathologic Processes Ramipril Valsartan Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 22, 2013