HypotensionPhase 2NCT01672008
NOX-100 for Preventing Hypotension During Hemodialysis
A Phase 2 study testing NOX-100 in people with Hypotension, run by Medinox, Inc. at 6 sites in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypotension
- What is being tested?
- NOX-100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 6 sitesTaiwan
- Study dates
- Aug 2012to Jul 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Keelung Chang Gung Memorial Hospital
Keelung, 20401
Far Eastern Memorial Hospital
New Taipei City, 22056
Buddhist TzuChi General Hospital, Taipei Branch
New Taipei City, 23142
China Medical University Hospital
Taichung, 40447
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 11168
About this study
Official title: A Phase IIa Study of Safety and Efficacy of NOX-100 for Preventing Hypotension in Patients During Hemodialysis Sessions
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).
Read the detailed description
This is a 2-stage, prospective, randomized, double-blind, multi-dose, placebo-controlled, cross-over, phase IIa study to evaluate the safety, tolerability and efficacy profiles of NOX-100 to reduce the number of intradialytic hypotension episodes. At single-blind stage I, the eligible subject will receive a 1-week run-in period followed by a 1-week NOX-100 treatment in a dose of 0.4mg/kg/hr. To evaluate the clearance of NOX-100, plasma levels of NOX-100 at the end of the 1st dialysis and prior to the 2nd dialysis will be measured. An interim analysis will be undertaken after the completion of first stage. The following process should be conducted only if the plasma level of NOX-100 decreases by 90% or more in these patients and all safety data have been reviewed by the medical monitor.
At double blind stage II, patients will be randomized 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
After a 1-week placebo, the subjects will receive the two 4-week treatment (sequence A or sequence B)which are separated by 1-week wash-out. In the NOX-100 treatment phase, subjects will subsequently receive NOX-100 in doses of 1.2, 2.5, 5, and 10 mg/kg/hr at the first three dialysis sessions over each week. In the placebo treatment phase, subjects will receive comparative placebo for four weeks. For the first 20 subjects, the treatment dose could be escalated only after the individual safety data have been reviewed by an unblinded medical monitor.
To confirm if there is hepatic metabolism of NOX-100 between dialysis sessions, a pre-dialysis plasma level will be tested at the 2nd dialysis of Week 2, 5, 7 and 10 in the second stage.
In both stages, the blood pressure will be measured pre-HD, every 30 minutes during HD and post-HD for monitoring the hypotension episode. For safety assessment, all AE(s), SAE(s) and any signs/symptoms during HD will be recorded. The safety of study drug will be followed until 4 weeks after last treatment.
A Data and Safety Monitoring Board (DSMB) will be established prior to start of the trial and the DSMB meeting will be hold every 6~12 months during study period. Both medical monitor and DSMB will be responsible for safeguarding the interests of trial participants.
- Conditions
- Hypotension
- Being tested
- NOX-100
- Keywords
- NOX-100
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOX-100Drug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: NOX-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypotension episode requiring intervention
Number reduction of symptomatic hypotension requiring intervention during HD with NOX-100 treatment.
Measured: 10 weeks
Secondary outcomes (3)
systolic blood pressure (SBP)
Change in systolic blood pressure
Measured: 10 weeks
Onset of symptoms of hypotension during HD
Time to onset of symptoms of hypotension during HD
Measured: 10 weeks
The need for treatment intervention to raise BP.
Time to conduct a treatment intervention to raise BP
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinox, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orient Europharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Monte Lai, Ph.D., Study chair, Medinox, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672008
- Sponsor's protocol ID
- NOX-100-ORIENT201
- Status last verified
- Dec 2015
- First submitted
- 21 Aug 2012
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Study of Safety and Efficacy of NOX-100 for Preventing Hypotension in Patients During Hemodialysis Sessions
- ClinicalTrials.gov ID
- NCT01672008
- Acronym / sponsor ID
- NOX-100-ORIENT201
- Conditions
- Hypotension
- Keywords
- NOX-100
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medinox, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Orient Europharma Co., Ltd.
- Study start
- Aug 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a 2-stage, prospective, randomized, double-blind, multi-dose, placebo-controlled, cross-over, phase IIa study to evaluate the safety, tolerability and efficacy profiles of NOX-100 to reduce the number of intradialytic hypotension episodes. At single-blind stage I, the eligible subject will receive a 1-week run-in period followed by a 1-week NOX-100 treatment in a dose of 0.4mg/kg/hr. To evaluate the clearance of NOX-100, plasma levels of NOX-100 at the end of the 1st dialysis and prior to the 2nd dialysis will be measured. An interim analysis will be undertaken after the completion of first stage. The following process should be conducted only if the plasma level of NOX-100 decreases by 90% or more in these patients and all safety data have been reviewed by the medical monitor.
At double blind stage II, patients will be randomized 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
After a 1-week placebo, the subjects will receive the two 4-week treatment (sequence A or sequence B)which are separated by 1-week wash-out. In the NOX-100 treatment phase, subjects will subsequently receive NOX-100 in doses of 1.2, 2.5, 5, and 10 mg/kg/hr at the first three dialysis sessions over each week. In the placebo treatment phase, subjects will receive comparative placebo for four weeks. For the first 20 subjects, the treatment dose could be escalated only after the individual safety data have been reviewed by an unblinded medical monitor.
To confirm if there is hepatic metabolism of NOX-100 between dialysis sessions, a pre-dialysis plasma level will be tested at the 2nd dialysis of Week 2, 5, 7 and 10 in the second stage.
In both stages, the blood pressure will be measured pre-HD, every 30 minutes during HD and post-HD for monitoring the hypotension episode. For safety assessment, all AE(s), SAE(s) and any signs/symptoms during HD will be recorded. The safety of study drug will be followed until 4 weeks after last treatment.
A Data and Safety Monitoring Board (DSMB) will be established prior to start of the trial and the DSMB meeting will be hold every 6~12 months during study period. Both medical monitor and DSMB will be responsible for safeguarding the interests of trial participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOX-100/Placebo | Experimental | Drug: 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 |
| Placebo/NOX-100 | Experimental | Drug: 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NOX-100 | Drug | NOX-100/Placebo, Placebo/NOX-100 |
Primary outcome
Number of hypotension episode requiring intervention
Time frame: 10 weeks
Number reduction of symptomatic hypotension requiring intervention during HD with NOX-100 treatment.
3 secondary outcomes
systolic blood pressure (SBP)
Time frame: 10 weeks
Onset of symptoms of hypotension during HD
Time frame: 10 weeks
The need for treatment intervention to raise BP.
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monte Lai, Ph.D. study chair
Medinox, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NOX-100 in people with Hypotension, run by Medinox, Inc. at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypotension episode requiring intervention (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2015.