Hypotension | NOX-100 for Preventing Hypotension During Hemodialysis
Hypotension research study
What is the primary objective of this study?
This study is designed to evaluate the safety, tolerability and efficacy profile of NOX-100 to reduce intradialytic hypotension (IDH) in patients undergoing chronic hemodialysis (HD).
Who is eligible to participate?
Inclusion Criteria: - Males or non-pregnant, non-lactating females 20-80 years of age - Patients who are hemodialysis dependent with a history of end-stage renal disease (ESRD) for at least 3 months and need at least three HD sessions per week - History of intradialytic hypotension defined by at least 4 episodes with a fall in SBP of > 20 mmHg within 30 days prior to signing the ICF. At least two of the episodes must have caused symptoms requiring an intervention - No change in anti-hypertensive regimen for at least one month prior to enrollment/randomization - Be willing to sign the Informed Consent Form Exclusion Criteria: - Subjects with adequate laboratory results at screening - Subjects with major psychiatric illness - Subjects with history of arrhythmia or severe congestive heart failure (New York Heart Association (NYHA) Class III and IV) within past 6 months, or those with hypoxic myocardium confirmed by EKG - Subjects with history of cirrhosis - Subjects with active infection disease defined as current treatment with anti-infection agent(s) - Subjects who need to receive nitrate and nitrite medication(s) (such as nitroglycerin, isosorbide mononitrate, and isosorbide dinitrate) for regular treatment - Subjects who need to receive unstable dose of midodrine, etilefrine or amezinium treatment within 7 days prior to receive the study treatment. - More than 14 drinks of alcohol per week - Use of any investigational drug or participation in any drug study within 30 days prior to enrollment/randomization - Any clinical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study as judged by the investigator
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
NOX-100/PlaceboAfter enrollment, subjects will be randomly assigned to one of the following treatment sequences in a 1:1 ratio. Sequence A: NOX-100 treatment phase followed by Placebo treatment phase Sequence B: Placebo treatment phase followed by NOX-100 treatment phase
Placebo/NOX-100After enrollment, subjects will be randomly assigned to one of the following treatment sequences in a 1:1 ratio. Sequence A: NOX-100 treatment phase followed by Placebo treatment phase Sequence B: Placebo treatment phase followed by NOX-100 treatment phase
Start Date: August 2012
Completed Date: July 2015
Phase: Phase 2
Primary Outcome: Number of hypotension episode requiring intervention
Secondary Outcome: systolic blood pressure (SBP)
Study sponsors, principal investigator, and references
Principal Investigator: Monte Lai, Ph.D.
Lead Sponsor: Medinox, Inc.
Collaborator: Orient Europharma Co., Ltd.