NCT01672008

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2012

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

August 21, 2012

Last Update Submit

December 30, 2015

Conditions

Hypotension

Keywords

NOX-100

Outcome Measures

Primary Outcomes (1)

  • Number of hypotension episode requiring intervention

    Number reduction of symptomatic hypotension requiring intervention during HD with NOX-100 treatment.

    10 weeks

Secondary Outcomes (3)

  • systolic blood pressure (SBP)

    10 weeks

  • Onset of symptoms of hypotension during HD

    10 weeks

  • The need for treatment intervention to raise BP.

    10 weeks

Study Arms (2)

NOX-100/Placebo

EXPERIMENTAL

After 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

Drug: NOX-100

Placebo/NOX-100

EXPERIMENTAL

After 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

Drug: NOX-100

Interventions

NOX-100DRUG
NOX-100/PlaceboPlacebo/NOX-100

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Keelung Chang Gung Memorial Hospital

Keelung, 20401, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, 22056, Taiwan

Location

Buddhist TzuChi General Hospital, Taipei Branch

New Taipei City, 23142, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 11168, Taiwan

Location

MeSH Terms

Conditions

Hypotension

Interventions

nitric oxide scavenger 100

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Monte Lai, Ph.D.

    Medinox, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2012

First Posted

August 24, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations

TW(6)