Clinical Trials List
2011-06-01 - 2014-12-31
Phase II
Terminated5
Study ended1
A Phase IIa study of safety and efficacy of NOX-100 for preventing hypotension in patients during hemodialysis sessions.
-
Trial Applicant
Orient EuroPharma Co., Ltd.
-
Sponsor
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/19
Investigators and Locations
Co-Principal Investigator
- 田祐霖 Division of Nephrology
- Chien-Hsing Wu Division of Nephrology
- 郭健群 Division of Nephrology
- 黃惠勇 Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chiz-Tzung Chang Division of Nephrology
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Safety profile of NOX-100, including the incidence and severity of:
Adverse event
Serious adverse event
Primary efficacy endpoint:
Number of hypotension episode requiring intervention
Secondary efficacy endpoints:
1. Change in SBP during HD
2. Time to onset of symptoms of hypotension during HD
3. Time to conduct a treatment intervention to raise BP
Exploratory endpoint:
Clearance of NOX-100 under 0.4 mg/kg/hr treatment profile
Pre-dialysis blood level of NOX-100 at the 2nd dialysis under 1.2, 2.5, 5 and 10 mg/kg/hr treatment profile
Inclution Criteria
* Females of childbearing potential may be enrolled in the study but must be willing to use two effective forms of contraception, including at least one barrier method, during and one month after study participation.
2. Patients who are hemodialysis dependent with a history of end-stage renal disease (ESRD) for at least 3 months and needing at least three HD sessions per week
3. History of intradialytic hypotension* defined by at least 4 episodes of symptomatic hypotension requiring intervention in the month prior to enrollment/randomization
* Excluding those caused by a specific reason, such as dehydration, heart failure, medication(s) such as erythropoietin (EPO) or reasons other than dialysis.
4. No change in anti-hypertensive regimen for at least one month prior to enrollment/randomization
5. Be willing to sign the Informed Consent Form
Exclusion Criteria
o Hgb 9 g/dl
o ALT or AST values > 3 x the upper limit of normal (ULN)
o Positive HCG, only in female of childbearing potential
2. Subjects with major psychiatric illness
3. Subjects with history of arrhythmia or severe congestive heart failure (New York
Heart Association (NYHA) Class III and IV), or those with hypoxic myocardium confirmed by EKG
4. Subjects with history of cirrhosis
5. Subjects with active infection disease defined as current treatment with antiinfection
agent(s)
6. Subjects who need to receive nitrate and nitrite medication(s) (such as nitroglycerin, isosorbide mononitrate, and isosorbide dinitrate) during study period.
7. Subjects who need to receive midodrine, etilefrine or amezinium treatment during study period.
8. More than 14 drinks of alcohol per week One drink = one bottle of beer (about 4.5% alcohol) or one glass of wine (about 12.9% alcohol) or one shot glass of distilled spirits (about 40% alcohol)
9. History of illegal drug use within the past 2 years
10. Use of any investigational drug or participation in any drug study within 30 days
prior to enrollment/randomization
11. Inability to understand the informed consent or to follow the protocol procedures
12. 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
The Estimated Number of Participants
-
Taiwan
75 participants
-
Global
75 participants
