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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2007-001407-37-GB |
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Date of registration:
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16/05/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A multicentre, randomised, double-blind, placebo-controlled study of the effects of KW-3902 Injectable Emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalised for volume overload and require intravenous diuretic therapy. - PROTECT-1
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Scientific title:
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A multicentre, randomised, double-blind, placebo-controlled study of the effects of KW-3902 Injectable Emulsion on heart failure signs and symptoms and renal function in subjects with acute heart failure syndrome and renal impairment who are hospitalised for volume overload and require intravenous diuretic therapy. - PROTECT-1 |
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Date of first enrolment:
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24/05/2007 |
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Target sample size:
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660 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001407-37 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Germany
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Hungary
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Italy
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Netherlands
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Spain
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Able to provide written informed consent or a legally authorized representative is able to provide written informed consent
2. Male or female 18 years of age or greater
3. History of heart failure of at least 14 days duration for which diuretic therapy has been prescribed
4. Hospitalized for AHFS requiring IV diuretic therapy. AHFS is defined as dyspnea at rest or with minimal exertion and signs of fluid overload manifested by at least one of the following at time of randomization:
• JVP >8 cm, or
• Pulmonary rales =1/3 up the lung fields, not clearing with
cough, or
• =2+ peripheral edema, or pre-sacral edema
5. Eligible for start of study drug infusion within 24 hours from presentation to the hospital, including the emergency department
6. Anticipated need for IV furosemide =40 mg/day (or equivalent dose of IV loop diuretic) for at least 24 hours after start of study drug
7. Impaired renal function defined as a creatinine clearance on admission between 20-80 mL/min using the Cockcroft-Gault equation for estimating creatinine clearance (corrected for height in edematous or obese subjects =100 kg)
8. Systolic blood pressure =95 mmHg (subjects with a systolic blood pressure of 90 –94 mmHg at randomization may be included if their usual systolic blood pressure measurements are consistently within this range while clinically stable)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Pregnant or breast feeding women. Women of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment.
2. Acute contrast induced nephropathy
3. Temperature >38°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
4. Serum potassium <3.5 mEq/L (3.0-3.4 mEq/L will be allowed if parenteral supplemental potassium is being administered)
5. Ongoing or planned IV therapy for AHFS with positive inotropic agents, vasopressors, vasodilators, or mechanical support (intraaortic balloon pump, endotracheal intubation, ventricular assist device) with the exception of IV nitrates
6. BNP <500 pg/mL or NT-pro-BNP <2000 pg/mL
7. Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis
8. Severe pulmonary disease (as evidenced by pre-admission or current oral steroid dependency, current treatment with IV steroids, or previous history of CO2 retention or intubation for acute exacerbation)
9. Significant stenotic valvular disease (severe aortic stenosis, mitral stenosis)
10. Heart transplant recipient or admitted for cardiac transplantation
11. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening
12. AHFS due to significant arrhythmias (ventricular tachycardia, bradyarrhythmias with slow ventricular rate [<45 beats per minute] or atrial fibrillation/flutter with a rapid ventricular response of >120 beats per minute)
13. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. This criterion does not include restrictive patterns seen on Doppler.
14. Known hepatic impairment (total bilirubin >3 mg/dL, albumin <2.8 mg/dL, or increased ammonia levels if performed)
15. Non-cardiac pulmonary edema, including suspected sepsis
16. Administration of an investigational drug or device, or participation in another trial, within 30 days before randomization
17. Current or anticipated therapy with atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
18. Systolic blood pressure >160 mmHg at randomization
19. Inability to follow instructions or comply with follow-up procedures
20. Allergy to soybean oil or eggs
21. History of seizure (except febrile seizure)
22. Stroke within 2 years
23. History of or current brain tumor of any etiology
24. Brain surgery within 2 years
25. Encephalitis/meningitis within 2 years
26. History of penetrating head trauma
27. Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years
28. History of, or at risk for, alcohol withdrawal seizures
29. Advanced Alzheimer’s disease
30. Advanced multiple sclerosis
31. Hgb <8 g/dL, Hct <25%, or the need for a blood transfusion
32. Previous exposure to KW-3902
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients being admitted to hospital for acute heart failure (AHFS) with volume overload and renal impairment.
MedDRA version: 9.1
Level: LLT
Classification code 10000803
Term: Acute heart failure
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Intervention(s)
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Product Name: KW-3902 Injectable Emulsion
Product Code: KW-3902IV
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Not available
CAS Number: 136199-02-5
Current Sponsor code: KW-3902
Other descriptive name: Not available
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Emulsion for injection
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Secondary Objective: The secondary objectives of this study are to evaluate the safety of KW-3902IV in subjects hospitalised with AHFS, volume overload and renal impairment and to estimate and compare within trial medical resource utilization and direct medical costs between patients treated with KW-3902IV versus placebo.
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Main Objective: The main objective of this study is to evaluate the effect of KW-3902IV in addition to intravenous (IV) loop diuretic therapy on heart failure signs and symptoms and renal function in subjects hospitalised with AHFS, volume overload, and renal impairment.
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Primary end point(s): A three category, ordered outcome of treatment success, patient unchanged, or treatment failure based on the following definitions:
• Treatment success (determined at 24 and 48 hours after the start of study drug [Day 2 and 3] or the day of discharge if earlier):
o Dyspnea reported by the patient using a 7-point Likert scale as moderately or markedly better compared to study start, AND
o Not a treatment failure
• Patient Unchanged: Neither treatment success or treatment failure
• Treatment failure (includes any 1 of the following criteria):
o Death or readmission for heart failure any time through Day 7;
OR
o Worsening symptoms and/or signs of heart failure occurring >24 hours after the start of study drug to Day 7 or discharge, whichever occurs first, such that there is a need for any one of the following types of “rescue therapy”:
an increase in the dose or reinstitution of IV loop diuretic therapy, or initiation of oral metolazone or IV chlorothiazide as accompanying therapy to loop diuretics
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initiation of ultrafiltration
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initiation of IV positive inotropes, vasopressors, or IV vasodilators
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initiation of mechanical ventilatory (including BiPAP or CPAP) or circulatory support
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Renal impairment as defined by a serum creatinine (SCr) increase of =0.3 mg/dL, or the initiation of hemofiltration or dialysis, from randomization to Day 7.
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Secondary ID(s)
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2007-001407-37-DE
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CKI- 301
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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