Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-003636-88
    Sponsor's Protocol Code Number:KBP5074-3-001
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-05-09
    Trial 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-003636-88
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of KBP-5074, a Mineralocorticoid Receptor Antagonist, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease
    Fázis 3, randomizált, kettős- vak, placebo kontrollált, multicentrikus vizsgálat a mineralokortikoid receptor antagonista KBP-5074 hatásosságának és biztonságosságának értékelése nem kontrollálható magas vérnyomásban szenvedő betegeknél, akiknél mérsékelt vagy súlyos (stage 3B/4) krónikus vesebetegség áll fenn.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Efficacy and Safety of KBP-5074, in Subjects with Uncontrolled Hypertension Who Have Moderate or Severe (Stage 3b/4) Chronic Kidney Disease
    Vizsgálat a KBP-5074 hatásosságának és biztonságosságának értékelésére nem kontrollálható magas vérnyomásban szenvedő betegeknél, akiknél mérsékelt vagy súlyos (stage 3B/4) krónikus vesebetegség áll fenn.
    A.4.1Sponsor's protocol code numberKBP5074-3-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04968184
    A.5.4Other Identifiers
    Name:INDNumber:117743
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKBP BioSciences PTE. Ltd.
    B.1.3.4CountrySingapore
    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 supportKBP BioSciences PTE. Ltd.
    B.4.2CountrySingapore
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKBP BioSciences PTE. Ltd.
    B.5.2Functional name of contact pointKBP Biosciences Clinical Trial Cont
    B.5.3 Address:
    B.5.3.1Street Address80 Robinson Road #02-00
    B.5.3.2Town/ citySingapore
    B.5.3.3Post code068898
    B.5.3.4CountrySingapore
    B.5.4Telephone number1(609) 874-0416
    B.5.6E-mailkbp5074clarion-ckd@kbpbiosciences.com
    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 nameKBP-5074
    D.3.2Product code KBP-5074
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1359969-24-6
    D.3.9.2Current sponsor codeKBP-5074
    D.3.9.3Other descriptive nameKBP-5074
    D.3.9.4EV Substance CodeSUB222445
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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 nameKBP-5074
    D.3.2Product code KBP-5074
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1359969-24-6
    D.3.9.2Current sponsor codeKBP-5074
    D.3.9.3Other descriptive nameKBP-5074
    D.3.9.4EV Substance CodeSUB222445
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uncontrolled hypertension in patients who have Stage 3b/4 chronic kidney disease
    Kontrollálhatatlan magas vérnyomásban szenvedő betegek, akiknél 3b/4 stádiumú krónikus vesebetegség áll fenn.
    E.1.1.1Medical condition in easily understood language
    Uncontrolled hypertension in patients who have Stage 3b/4 chronic kidney disease
    Kontrollálhatatlan magas vérnyomásban szenvedő betegek, akiknél 3b/4 stádiumú krónikus vesebetegség áll fenn.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066860
    E.1.2Term Uncontrolled hypertension
    E.1.2System Organ Class 100000004866
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10076410
    E.1.2Term Chronic kidney disease stage 3
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10076411
    E.1.2Term Chronic kidney disease stage 4
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy and durability of KBP-5074 in reducing systolic blood pressure (SBP).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To evaluate the effect of KBP-5074 on diastolic blood pressure (DBP) and urine albumin:creatinine ratio (UACR);
    • To evaluate the safety and tolerability of KBP-5074.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject must be ≥18 years of age at the Screening Visit (Visit 1).
    • Body mass index (BMI) must be ≥19 to <45 kg/m2at the Screening Visit (Visit 1).
    • Subject must have uncontrolled hypertension defined as meeting both of the following criteria:
    - The subject has a resting seated trough cuff SBP ≥140 mm Hg at the Screening Visit (Visit 1), and at the start (Visit 2) and end (Visit 3) of the Run-In Period.
    - The subject is taking 2 or more antihypertensive medications that have been titrated upward as tolerated to hypertension target doses per local SoC and have been stable (i.e., without any dose adjustments) from 4 weeks before the Screening Visit (Visit 1) through the end of the Run-In Period (Visit 3).
    ◦ The antihypertensive medications must include at least 1 loop, thiazide, or thiazide-like diuretic unless the subject has a documented intolerance to or contraindication for diuretic therapy.
    ◦ A subject on 1 antihypertensive medication that has been titrated upward as tolerated to a hypertension target dose per local SoC and has been stable during the 4 weeks prior to the Screening Visit (Visit 1) may be enrolled in the study if the subject has a documented history of intolerance to multiple antihypertensive medications.
    • The subject must have Stage 3b (eGFR ≥30 and ≤44 mL/min/1.73 m2) or Stage 4 (eGFR ≥15 and <30 mL/min/1.73 m2) CKD.
    E.4Principal exclusion criteria
    Subject has a serum potassium level >4.8 mmol/L according to central laboratory results during the Screening or Run-In Periods.
    • Subject has had a serum potassium level >5.6 mmol/L within 2 weeks before the Screening Visit (Visit 1).
    • Subject has been hospitalization for hyperkalemia within the 3 months before the Randomization Visit (Visit 3).
    • Subject was not compliant with taking placebo during the Run-in Period (defined as taking <80% or >120% of planned placebo doses) or the Investigator determines that the subject was not compliant with background antihypertensive medications during the Run-in Period as assessed at the Randomization Visit (Visit 3).
    • Subject has taken an MRA, a potassium-sparing diuretic, or chronic potassium supplements during the 4 weeks before the Screening Visit (Visit 1).
    • Subject has taken potassium binders for the treatment of hyperkalemia during the 3 months before the Screening Visit (Visit 1).
    • Subject has taken a strong CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for efficacy is change in seated trough cuff SBP from baseline to Week 12.
    The second key endpoint for durability is change in seated trough cuff SBP from Week 48 to Week 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 12
    From Week 48 to Week 52
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints for the study are:
    • Change in seated trough cuff SBP from baseline to Week 24;
    • Changes in seated trough cuff DBP from baseline to Week 12 and Week 24;
    • Changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR ≥30 mg/g at baseline.
    Other secondary efficacy endpoints for the study are:
    • Changes in seated trough cuff SBP and DBP from baseline to Week 48;
    • Percentage changes in UACR from baseline to Week 12 and Week 24 for subjects with UACR ≥30 mg/g at baseline;
    • Changes and percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 for subjects with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline;
    • Changes and percentage changes in UACR from baseline to Week 12, Week 24, and Week 48 for subjects with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline;
    • Change in seated trough cuff DBP from Week 48 to Week 52;
    • Change and percentage change in UACR from Week 48 to Week 52 for subjects with UACR ≥30 mg/g at baseline;
    • Change and percentage change in UACR from Week 48 to Week 52 for subjects with macroalbuminuria (defined as UACR ≥300 mg/g) at baseline;
    • Change and percentage change in UACR from Week 48 to Week 52 for subjects with microalbuminuria (defined as UACR ≥30 and <300 mg/g) at baseline.
    Safety assessments include evaluation of AEs, vital signs, clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination findings.
    Safety endpoints for this study are:
    • Incidences of SAEs, non-serious AEs, AEs leading to discontinuation of study drug, and AEs leading to discontinuation from the study;
    • Incidences of AEs of hyperkalemia, hypertension, and hypotension;
    • Incidences of serum potassium >5.0 to <5.6 mmol/L, ≥5.6 to <6.0 mmol/L, and ≥6.0 mmol/L by central laboratory results;
    • Changes in serum potassium levels from baseline to Week 12, Week 24, and Week 48 by central laboratory results;
    • Changes in eGFR from baseline to Week 12, Week 24, and Week 48 by central laboratory results;
    • Incidence of sustained decreases in eGFR of ≥30% from baseline by central laboratory results (an eGFR decrease of ≥30% from baseline will be considered sustained if the eGFR reduction is still ≥30% from baseline at least 4 weeks after the initial measurement);
    • Change in serum potassium levels from Week 48 to Week 52 by central laboratory results;
    • Change in eGFR from Week 48 to Week 52 by central laboratory results.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Durability, tolerability
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    China
    Korea, Republic of
    Malaysia
    United States
    Bulgaria
    Netherlands
    Spain
    Czechia
    Germany
    Belgium
    Denmark
    Georgia
    Hungary
    Ukraine
    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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 195
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 405
    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 No
    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 state73
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of care
    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 Decision2022-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-30
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 06 21:39:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA