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    Summary
    EudraCT Number:2011-003025-10
    Sponsor's Protocol Code Number:VIVID
    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:2011-09-06
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-003025-10
    A.3Full title of the trial
    Effect of active vitamin-D treatment on left ventricular hypertrophy in patients with type-2 diabetes and stage-3 chronic kidney disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of active vitamin D (calcitriol) on left ventricular hypertrophy in type 2 diabetic patients with chronic kidney disease.
    A.3.2Name or abbreviated title of the trial where available
    VItamin D in left VentrIcular hypertrophy Diabetes (VIVID) Trial.
    A.4.1Sponsor's protocol code numberVIVID
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Foundation for the Study of Diabetes (EFSD)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Luigi Gnudi
    B.5.3 Address:
    B.5.3.1Street AddressRoom 3.11, FWB building, Stamford Street, KCL Waterloo Campus,
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9NH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00442078484413
    B.5.5Fax number00442078484567
    B.5.6E-mailluigi.gnudi@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorGuy's and St Thomas NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEuropean Foundation for the Study of Diabetes (EFSD)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St Thomas NHS Foundation Trust
    B.5.2Functional name of contact pointDr Luigi Gnudi
    B.5.3 Address:
    B.5.3.1Street AddressRoom 3.11, FWB building, Stamford Street, KCL Waterloo Campus,
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 9NH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00442078484413
    B.5.5Fax number00442078484567
    B.5.6E-mailluigi.gnudi@kcl.ac.uk
    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 Yes
    D.2.1.1.1Trade name Rocaltrol
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCalcitriol
    D.3.4Pharmaceutical form Capsule
    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 INNcalcitriol
    D.3.9.3Other descriptive nameVitamin D
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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 placeboCapsule
    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
    Left ventricular hypertrophy, type 2 diabetes, chronic kidney disease.
    E.1.1.1Medical condition in easily understood language
    Increase in heart mass, diabetes, long-term kidney disease.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10047295
    E.1.2Term Ventricular hypertrophy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10012612
    E.1.2Term Diabetes mellitus non insulin-dep
    E.1.2System Organ Class 100000004861
    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 research question is to evaluate the effect of Calcitriol treatment as compared to placebo on left ventricular mass in patients with type 2 diabetes, left ventricular hyperthrophy and chronic kidney disease. Left ventricular hypertrophy is a marker and predictor of cardiovascular disease risk. Left ventricular mass will be assessed by magnetic resonance imaging. Interventions that reduce left ventricular hypertrophy may prevent cardiovascular disease.
    Currently it is not known if treatment with Calcitriol can affect left ventricular mass in patients with diabetes, left ventricular hypertrophy and kidney disease. We wish to study the effect of Calcitriol or placebo as add on treatment to existing medical treatments on left ventricular mass in a placebo controlled double blind study. Patients will continue with other medical treatments for their diabetes and kidney disease.
    E.2.2Secondary objectives of the trial
    Secondary research questions will be to evaluate the effect of Calcitriol treatment as compared to placebo on interstitial myocardial fibrosis. Other secondary questions will be to compare the effect of calcitriol and placebo on augmentation left ventricular end-systolic volume, left ventricular end diastolic volume, left ventricular ejection fraction, pulse wave velocity by MRI, and if no contraindication exists cardiac perfusion. Similar to the left ventricular mass measurements all these determinations are also non invasive. Other secondary endpoints questions include blood pressure, pulse wave velocity by applanation tonometry, kidney function as measured by estimated glomerular filtration rate, changes in calcium and phosphate levels in the blood and hormones involved in regulating bone metabolism and blood pressure and quality of life as measured by a questionnaire.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A sub study of the VItamin D in left VentrIcular hypertrophy Diabetes (VIVID) trial to investigate the effects of active vitamin D on endothelial function in patients with type 2 diabetes and stage 3 chronic kidney disease.

    E.3Principal inclusion criteria
    - Patients with a diagnosis of T2DM;
    - Patients aged ≥ 40 years old (inclusive);
    - Chronic Kidney disease (CKD) stage 3 [estimated glomerular filtration rate (eGFR*) 30-59 ml/min on the two most recent (within 12 months) consecutive measurements];
    - A history of an elevated urinary albumin excretion rate (UAER) [albumin: creatinine ratio ≥ 2.5 mg/mmol in men and ≥ 3mg/mmol in women on more than three occasions or UAER ≥ 20mcg/min on at least two timed urine collections, or two or more positive urine dipsticks results for proteinuria or two or more urine protein creatinine ratios (PCR)>15 mg/mmol] or clinical diagnosis of diabetic nephropathy.
    - Normal corrected serum calcium (2.1-2.6mmol/l);
    - Normal phosphate (0.8-1.5 mmol/l) levels;
    - Intact parathyroid hormone (iPTH) level between 30 pg/ml and 300 pg/ml at screening visit or a history of a raised iPTH level between 30 pg/ml and 300 pg/ml in the 3 months preceding screening visit;
    - History of LVH as defined by on ECG (The Sokolow-Lyon index (46): S in V1 + R in V5 or V6 -whichever is larger- ≥ 35 mV) or R wave in lead AVL >1mV (48) or , and MRI criteria (>67g/m2 for female; >76g/m2 for males)(49) or increased posterior wall thickness ≥1.1 cm in men or ≥1.0 in women on echocardiography ;
    - Anti-hypertensive therapy with inhibitors of the renin angiotensin system (RAS), on a stable dose for at least 1 month prior to randomisation;
    - Written informed consent to participate in the study prior to any study procedures;
    - Ability to communicate and comply with all study requirements.
    *eGFR calculated by 4 variable MDRD equation
    E.4Principal exclusion criteria
    - No evidence of LVH
    - History (in the previous 2 months) or current vitamin-D replacement;
    - Poorly controlled hypertension (systolic and diastolic blood pressure >180mmHg and >110 mmHg respectively);
    - Patients is expected to receive an increase in the dose of renin-angiotensin-system (RAS) inhibitors during the course of study;
    - Hypercalcaemia (corrected calcium >2.6mmol/l);
    - Pre-existing known valvular heart disease, rhythm disturbances, pericardial effusion, structural heart disease;
    - Any acute concurrent illness in the previous 6 months (e.g. malignancy, severe gastrointestinal disease);
    - iPTH > 300 pg/ml;
    - Contraindications to cardiac MRI;
    - History of non-diabetic or obstructive kidney disease;
    - Pregnancy or lactation;
    - History of a cardiovascular or cerebrovascular event in the preceding 6 months;
    - Patients not willing to use appropriate contraception.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point will be left ventricular mass index. The primary population used in this assessment will be the intention to treat population. The primary population used in these assessments will be the intention to treat population. Baseline is defined as visit 2. Endpoint will be defined as the last available post-baseline measurement of left ventricular mass index (up to and including visit 11).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The trial comprise a pre screening (-6 weeks) visit that precedes the randomization visit when patients will be randomised. The patients will then be followed up for 48 weeks and will be seen at 9 visits specifically at weeks: 4, 8, 12, 16, 20, 24, 30, 36, 48.
    The primary population used in these assessments will be the intention to treat population. Baseline is defined as visit 2. Endpoint will be defined as the last available post-baseline measurement of left ventricular mass index (up to and including visit 11).
    E.5.2Secondary end point(s)
    •ECG Sokolow-Lyon index;
    •Left ventricular end-systolic volume, left ventricular end-diastolic volume, and left ventricular ejection fraction;
    •Myocardium perfusion (exploratory secondary endpoint);
    •Interstitial myocardial fibrosis;
    •Aortic pulse wave velocity by MRI;
    •Aortic pulse wave velocity by applanation tonometry;
    •Estimated GFR;
    •Serum calcium, iPTH, and active vitamin-D levels;
    •High sensitivity CRP;
    •Systolic and diastolic blood pressure;
    •HbA1c;
    •Plasma renin activity and aldosterone levels;
    •First-morning urine albumin-creatinine ratio;
    •Progression to clinical indication for vitamin D replacement or iPTH ≥ 350 pg/ml;
    •Number of hypercalcaemic events requiring withdrawal from study;
    •Quality of life.
    Flow mediated dilatation, cardiac autonomic tests are exploratory secondary endpoints and will also be reported along with the above endpoints in final clinical study report (CSR)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The trial comprise a pre screening (-6 weeks) visit that precedes the randomization visit when patients will be randomised. The patients will then be followed up for 48 weeks and will be seen at 9 visits specifically at weeks: 4, 8, 12, 16, 20, 24, 30, 36, 48.
    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 No
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 years8
    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 years8
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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 clinical care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CLRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-29
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