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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42732   clinical trials with a EudraCT protocol, of which   7035   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2010-018285-23
    Sponsor's Protocol Code Number:18102009
    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:2010-06-07
    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 number2010-018285-23
    A.3Full title of the trial
    Effect of active vitamin D treatment on arterial stiffness and albuminuria 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
    Does vitamin D treatment have an effect on arterial stiffness and protein in urine in patients with type 2 diabetes and stage 3 chronic kidney disease
    A.3.2Name or abbreviated title of the trial where available
    Vitamin D in Diabetes Trial (VDDT)
    A.4.1Sponsor's protocol code number18102009
    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 supportDiabetes UK
    B.4.2CountryUnited Kingdom
    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 pointDiabetes Research
    B.5.3 Address:
    B.5.3.1Street Address3.11, FWB building, Stamford Street,
    B.5.3.2Town/ cityKCL Waterloo Campus, London
    B.5.3.3Post codeSE1 9NH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004402078484413
    B.5.5Fax number00440207848456
    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 supportDiabetes UK
    B.4.2CountryUnited Kingdom
    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 pointDiabetes Reasearch
    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 number004402078484413
    B.5.5Fax number004402078484567
    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
    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.3.4Pharmaceutical 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.3.9.1CAS number 32222-06-3
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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.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
    Diabetic kidney disease.
    E.1.1.1Medical condition in easily understood language
    Kidney disease caused by diabetes
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10009119
    E.1.2Term Chronic renal failure
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10067585
    E.1.2Term Type 2 diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    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 arterial stiffness in patients with type 2 diabetes and chronic kidney disease. Arterial stiffness is a marker and predictor of cardiovascular disease risk. Arterial stiffness will be assessed by aortic pulse wave velocity (Ao-PWV) which is a measure of arterial stiffness. Ao-PWV measures the the speed of transmission of the pulse wave along the aorta the largest blood vessel in the body. The greater the speed the greater the arterial stiffness. Interventions that recuce arterial stiffness may prevent cardiovascular disease.
    Currently it is not known if treatment with Calcitriol can affect arterial stiffness in patients with diabetes and kidney disease. We wish to study the effect of Calcitriol or placebo as add on treatment to existing medical treatments on arterial stiffness in a placebo controlled double blind study. Patients will continue with other medical treatments for their
    E.2.2Secondary objectives of the trial
    Secondary research questions will be to evaluate the effect of Calcitriol treatment as compared to placebo on the amount of the protein albumin in the urine which is a marker of kidney disease and heart disease. Other secondary questions will be to compare the effect of calcitriol and placebo on augmentation index (a measurement of the pulse wave reflection on central pressures) measured at the wrist over the radial artery with a small pencil like probe. Similar to the Aortic pulse wave velocity measurements this is also non invasive. Other secondary endpoints questions include blood pressure, 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 Diabetes Trial (VDDT) 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
    1. Patients with a diagnosis of T2DM.
    2. Patients aged between 40 and 75 years (inclusive).
    3. 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].
    4. 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 evidence of diabetic nephropathy
    5. Normal corrected serum calcium (2.1-2.6mmol/l).
    6. Normal phosphate (0.8-1.5 mmol/l) levels.
    7. A raised intact parathyroid hormone (iPTH) level between 30 pg/ml and 200pg/ml at screening visit or a history of a raised intact parathyroid hormone (iPTH) level between 30 pg/ml and 200pg/ml in the 3 months preceding screening visit.
    8. Written informed consent to participate in the study prior to any study procedures.
    9. Ability to communicate and comply with all study requirements.

    E.4Principal exclusion criteria
    • An iPTH ≥200 pg/ml at study entry (a conservative treatment threshold for initiating active vitamin D treatment for prevention of renal osteodystrophy).
    • History of non diabetic or obstructive kidney disease.
    • Poorly controlled hypertension (systolic and diastolic blood pressure >180mmHg and >110 mmHg respectively).
    • Presence of connective tissue diseases known to affect arterial vasculature.
    • Atrial fibrillation or other cardiac rhythm disorders.
    • Pregnancy or lactation.
    • History of a cardiovascular or cerebrovascular event in the preceding 6 months.
    • Patients already on vitamin D (inactive or active) treatment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point will be change from baseline in Ao-PWV. 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline is defined as visit 3. Endpoint will be defined as the last available post-baseline measurement of Ao-PWV (up to and including visit 7).
    E.5.2Secondary end point(s)
    Secondary endpoints will be change from baseline in; UAER, augmentation index, brachial and central systolic and diastolic blood pressure, progression to clinical indication for vitamin D replacement or iPTH≥200 pg/ml, eGFR, serum calcium and phosphate levels, alkaline phosphate levels, urine calcium excretion, quality of life, number of hypercalcaemic events requiring withdrawal from study, hsCRP, iPTH, plasma renin activity and active vitamin D levels.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
    All trial visits
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    both groups receive open label placebo for 12 weeks after 48 weeks treatment with active/placebo
    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 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 end of the study is defined as the date on which the last participant completes the last visit (includes follow−up visit).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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 routine 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 Decision2010-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-01
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA