Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3

NCT00878969 | Terminated Phase 3 Results DMC

• 2 other identifiers: Fibrinolysis in Dialysis Aim 3R01HL065193-08A2
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see how two classes of blood pressure medications,angiotensin-converting enzyme inhibitors (Ace inhibitors) and angiotensin receptor blockers (ARBs), differ in their long term effects on certain chemicals in the body and on the carotid arteries.

Conditions

Oxidative Stress; Endothelial Dysfunction

Keywords

Hemodialysis; fibrinolysis; oxidative stress; systemic inflammatory reaction; endothelial dysfunction; carotid intima media thickness (IMT; angiotensin receptor blockade; angiotensin converting enzyme inhibition

Outcome Measures

Primary Outcomes (1)

• Interleukin-6 (IL-6)

  IL-6 is a sensitive laboratory assay for serum levels of interleukin-6, which is a pro-inflammatory cytokine used to evaluate the inflammatory response.

  baseline and 18 months

Study Arms (3)

Valsartan

ACTIVE COMPARATOR

80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months

Drug: valsartan (ARB)

Ramipril

ACTIVE COMPARATOR

2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months

Drug: ramipril (ACE inhibitor)

Placebo

PLACEBO COMPARATOR

matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months

Drug: Placebo

Interventions

valsartan (ARB) DRUG

Also known as: Diovan

Valsartan

ramipril (ACE inhibitor) DRUG

Also known as: Altace

Ramipril

Placebo DRUG

Also known as: Inactive pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• On thrice weekly chronic hemodialysis for at least 6 months
• Clinically stable, adequately dialyzed \[single-pool Kt/V \> 1.2 or Urea Reduction Ratio (URR) \> 65%\] thrice weekly, with polysulphone membrane for at least 3 consecutive months prior to study

You may not qualify if:

• History of functional transplant less than 6 months prior to study
• Use of immunosuppressive drugs within 1 month prior to study
• History of active connective tissue disease
• History of acute infectious disease within one month prior to study
• 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 (intolerable) or angioedema
• Ejection fraction less than 30%
• Inability to discontinue ACE inhibitor or ARB
• Predialysis potassium repeatedly higher than 6.0 mmol/L (confirmed on a repeated blood draw)
• Anticipated live donor kidney transplant
• Pregnancy or breast-feeding
• History of poor adherence to hemodialysis or medical regimen

Sponsors & Collaborators

• Vanderbilt University: lead
• University of Washington: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Valsartan; Ramipril; Angiotensin-Converting Enzyme Inhibitors

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: T. Alp Ikizler, MD
• Organization: Vanderbilt University

alp.ikizler@vanderbilt.edu

615-343-6104

Study Officials

• Nancy J Brown, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Talat A Ikilzer, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Jonathan Himmelfarb, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2009
• First Posted: April 9, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 15, 2016
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

US (1)