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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-006843-29
    Sponsor's Protocol Code Number:CKI-303
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-02-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-006843-29
    A.3Full title of the trial
    A multicentre, randomized, double-blind, placebo controlled study of the effects of KW-3902 Injectable Emulsion on heart failure signs and symptoms, diuresis, renal function, and clinical outcomes in subjects hospitalized with worsening renal function and heart failure requiring intravenous therapy.
    A.3.2Name or abbreviated title of the trial where available
    REACH UP
    A.4.1Sponsor's protocol code numberCKI-303
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovaCardia Inc (wholly owned subsidiary of Merck & Co. Inc)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameKW-3902 Injectable Emulsion
    D.3.2Product code KW-3902 IV
    D.3.4Pharmaceutical form Emulsion for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 136199-02-5
    D.3.9.2Current sponsor codeKW-3902
    D.3.9.3Other descriptive nameNot available
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEmulsion for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients being admitted to hospital with heart failure and volume overload requiring IV therapy after experiencing worsening of renal function.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute heart failure
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to evaluate the effect of KW-3902 IV, in addition to standard therapy, on the proportion of worsening heart failure and worsening renal function after initiation of therapy through Day 7 or discharge, whichever occurs first.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the effect of KW-3902 IV, in addition to standard therapy, on the the proportion of deaths or rehospitalisations for heart failure or worsening renal function over 30 days, and to estimate and compare within-trial medical resource utilisation and direct medical costs between subjects treated with KW-3902 IV versus placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent, or a legally authorised representative is able to provide written informed consent.
    2. Male or female 18 years of age or greater.
    3. Dyspnea at rest or with minimal exertion at randomisation.
    4. Fluid overload as manifested by at least one of the following present at randomization:
    JVP >10 cm OR Pulmonary rales ≥1/3 up the lung fields, not clearing with cough,
    OR ≥2+ peripheral or pre-sacral edema
    5. Estimated creatinine clearance (CrCl) between 20–60 mL/min using the Cockcroft-Gault equation (corrected for height in edematous subjects ≥100 kg) based on a serum creatinine (SCr) value drawn within approximately 6 hours of randomization
    6. Worsening renal function as manifested by one of the following present at randomization:
    • An increase in SCr of at least 25% and at least 0.3 mg/dL from the time of initial presentation for this hospitalization in patients hospitalized with heart failure requiring IV diuretic therapy, OR
    • A documented increase in SCr over the preceding 30 days prior to randomization of at least 40% and at least 0.3 mg/dL in patients being admitted for heart failure requiring IV therapy (these patients must be randomized within 24 hours of
    admission)
    7. Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug
    8. BNP >500 pg/mL or NT-pro-BNP >2000 pg/mL
    9. Systolic blood pressure ≥90 mmHg at randomization. Subjects with systolic blood pressure of 85-89 mmHg at randomization may be included if their usual systolic blood pressure measurements are consistently within 85-89 mmHg while clinically stable.
    E.4Principal exclusion criteria
    1. Previous exposure to KW-3902
    2. Pregnant or breast feeding women. Women of child bearing potential must have a negative serum pregnancy test prior to enrollment.
    3. Any administration of IV radiographic contrast within 14 days of randomization or any procedures with IV radiographic contrast planned during this hospitalization
    4. Administration of IV vasodilators within 6 hours of randomization (with the exclusion of nitrates, which are allowed)
    5. Serum potassium <3.5 meq/L (3.0–3.4 meq/L will be allowed if adequate parenteral supplemental potassium is being administered)
    6. Ongoing or planned therapy for heart failure with mechanical circulatory support (intra-aortic balloon pump, endotracheal intubation, ventricular assist device) or ventilatory support (including BiPAP or CPAP)
    7. Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis during this hospitalization
    8. Rapidly progressive acute renal failure as manifested by an increase in SCr ≥0.7 mg/dL in a 24-hour period
    9. Evidence of acute tubular necrosis (urinary sediment, urinary sodium excretion, biopsy, etc.) or post-obstructive nephropathy or other exogenous causes of acute kidney injury, unrelated to heart failure or its treatment (contrast media,cyclosporine, other nephrotoxins)
    10. 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)
    11. Significant stenotic mitral or aortic valvular disease
    12. Heart transplant recipient or admitted for cardiac transplantation or LVAD surgery
    13. Any major surgery within 2 weeks prior to screening (cardiac or non-cardiac)
    14. Clinical evidence of acute coronary syndrome in the 2 weeks prior to screening
    15. Hgb <8 g/dL, Hct <25%, or active bleeding requiring transfusion
    16. Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. This criterion does not include restrictive patterns seen on Doppler.
    17. Known hepatic impairment (total bilirubin >3 mg/dL, albumin <2.8 mg/dL, or increased ammonia levels if performed)
    18. Non-cardiac pulmonary edema
    19. Temperature >38°C (oral or equivalent)
    20. Sepsis or active infection requiring IV anti-microbial treatment
    21. Administration of an investigational drug or device or participation in another trial within 30 days before randomization
    22. Current or anticipated therapy with atanazavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, or voriconazole
    23. Administration of any vasopressor or inotropic drug within 72 hours of randomization (with the exception of ongoing dopamine or dobutamine at doses ≤5 mcg/kg/min or milrinone at a dose of ≤0.25 mcg/kg/min, which are allowed IF at a stable dose for the preceding 24 hours AND provided there has been no decrease in SCr during the prior 24 hours)
    24. Inability to follow instructions or comply with study procedures
    25. Allergy to soybean oil or eggs
    26. History of seizure (except febrile seizure)
    27. Stroke within 2 years
    28. History of brain tumor of any etiology
    29. Brain surgery within 2 years
    30. Encephalitis/meningitis within 2 years
    31. History of penetrating head trauma
    32. Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years
    33. History of or at risk for alcohol withdrawal seizures
    34. Advanced Alzheimer’s disease
    35. Advanced multiple sclerosis
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of treatment failures within 30 days (includes any one of the following criteria):
    • Death or readmission for heart failure or worsening renal function through 30 days after randomization,
    OR
    • 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”:
    new diuretic initiation or a ≥50% dose increase of the IV diuretic daily dose, or initiation or increase in dose of oral metolazone or IV chlorothiazide as accompanying therapy to loop diuretics,
    or
    initiation of ultrafiltration
    or
    initiation of an IV inotrope or an increase in the dose of dopamine, dobutamine, or milrinone if these were in use at the time of randomization
    or
    initiation of mechanical ventilatory (including BiPAP or CPAP) or circulatory support
    OR
    • Worsening renal impairment as defined by an increase in SCr of ≥0.3 mg/dL, or the initiation of hemofiltration or dialysis, from the time of randomization to Day 7 or discharge, whichever occurs first.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will be concluded when the last patient enrolled has a minimum of 60 days follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-02-21. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 480
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-12
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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