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    Summary
    EudraCT Number:2011-005274-30
    Sponsor's Protocol Code Number:UCL_2011_DIDo
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-04-19
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-005274-30
    A.3Full title of the trial
    Efficacy and safety of a Double Icodextrin Dose in elderly incident CAPD patients on incremental Peritoneal Dialysis therapy: the DIDo study
    Efficacité et sécurité d’une double dose d’icodextrine chez des patients âgés, incidents en dialyse péritonéale continue ambulatoire (DPCA), débutant une dialyse péritonéale incrémentale: l’étude DIDo.
    Werkzaamheid en veiligheid van een dubbele dosis icodextrine bij oudere incident patiënten met een continue ambulante peritoneale dialyse (CAPD) en die behandeld worden met een incrementele peritoneale dialyse: de DIDo-studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of a Double Icodextrin Dose in ederly patients, starting treatment by Continuous Ambulatory Peritoneal Dialysis (CAPD)
    A.3.2Name or abbreviated title of the trial where available
    DIDo
    A.4.1Sponsor's protocol code numberUCL_2011_DIDo
    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 SponsorUniversité catholique de Louvain
    B.1.3.4CountryBelgium
    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 supportBaxter
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKeyrus Biopharma
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address53 rue Baudin
    B.5.3.2Town/ cityLevallois Perret
    B.5.3.3Post code92300
    B.5.3.4CountryFrance
    B.5.4Telephone number33141 34 12 05
    B.5.5Fax number33141 34 28 29
    B.5.6E-mailTaraneh.Khodabandehlou@keyrus.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 Yes
    D.2.1.1.1Trade name Extraneal
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Intraperitoneal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraperitoneal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNICODEXTRIN
    D.3.9.1CAS number 337376-15-5
    D.3.9.4EV Substance CodeSUB12443MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with chronic renal failure who are starting a Continuous Ambulatory Peritoneal Dialysis (CAPD) as first line dialyse.
    E.1.1.1Medical condition in easily understood language
    Chronic renal insuffciency
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10007184
    E.1.2Term CAPD
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority and safety of using 2, as compared to 1, icodextrin bags / day, in a cohort of elderly incident CAPD patients using incremental PD (3 bags / day), with the aim of prolonging the period of time for which incremental PD can be used.
    E.2.2Secondary objectives of the trial
    The secondary objective is to demonstrate the efficacy of the double icodextrin dose on various clinical and biological determinants as well as on safety issues.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Run-in period
    - Incident CAPD patients who require incremental PD and in whom at least 1.5L dialysate can be safely instilled,
    - Creatinine clearance <20ml/min
    - Age ≥ 65 years,
    - Patients willing and able to give written informed consent and comply with the requirements of the study protocol.
    Treatment period
    - Patients having successfully completed the run-in period (achieving euvolemia).
    E.4Principal exclusion criteria
    Run-in period
    - Contraindication for CAPD according to local practice,
    - Life expectancy < 6 months,
    - Known allergy to icodextrin (cloudy dialysate or skin rash),
    - Need for amino-acid prescription,
    - Treatment with any investigational product within 30 days prior to the signature of the informed consent form,
    - History of drug or alcohol abuse within 3 months prior to the signature of the informed consent form.
    Treatment period
    - Severe symptomatic arterial hypotension at the end of the run-in period in the Investigator’s opinion,
    - Excessive ultrafiltration (UF) during the run-in period,
    - Allergy to icodextrin discovered during the run-in period,
    - Impossibility to achieve adequate PD regimen within the run-in period (catheter dysfunction, peritoneal leaks, inadequate compliance, psycho-social reasons).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the proportion of patients stopping 3 bags / day for the following reasons:
    - Use of > 15 % hypertonic glucose dialysate 3.86 % or > 30 % hypertonic glucose dialysate 2.27 % over a 4-week period,
    - Transfer of the patient to another dialysis method (haemodialysis [HD], automated peritoneal dialysis [APD], CAPD with > 3 bags / day) for any reason,
    - Death of the patient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated at 9 months (visit 5)
    E.5.2Secondary end point(s)
    The secondary endpoints will demonstrate the efficacy of the double icodextrin dose on various clinical and biological determinants as well as on safety issues:
    - Metabolic control: glycosylated haemoglobin (HbA1c) and lipid concentration total, high-density lipoprotein [HDL], low-density lipoprotein [LDL], triglycerides, cholesterol),
    - Blood pressure control, evaluated by the number of anti-hypertensive agents and daily furosemide dose, and measured at the end of each study visit,
    - Nutritional aspect: serum albumin and prealbumin concentrations based on the changes in percentage at various time points compared to baseline (V2),
    - Inflammatory profile: C-reactive protein (CRP) concentrations,
    - Left ventricular mass calculated following ECG,
    - Quality of life according to the kidney disease quality of life (KDQoL) evaluation,
    - Residual renal function evaluated by calculated glomerular filtration rate (GFR, creatinine + urea clearances/2),
    - Peritoneal membrane permeability assessed by the peritoneal equilibration test (PET),
    - Number of hospitalisations and length (in days) of hospitalisation,
    - Adverse events (AEs), treatment-emergent AEs and serious adverse events (SAEs),
    - Serum sodium concentration and icodextrin metabolites concentration,
    - Relevant clinical problems related to serum sodium concentration and to icodextrin metabolites accumulation,
    - Incidence of skin rashes,
    - Incidence of sterile peritonitis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary variables will be summarised and compared between groups at each time point:
    - V2 (D0), V4 (M6), V6 (M12) and V7 (M18) for all variables except left ventricular mass which is not measured at V4 and V6,
    - V3 (M3) for all except quality of life, peritoneal membrane permeability (by PET) and left ventricular mass,
    - V5 (M9) for all except quality of life and peritoneal membrane permeability (by PET).
    In addition, change and percent change from baseline (V2) to each time point will be described and compared between groups for the following variables:
    - HbA1c and lipids concentrations (total, HDL, LDL, triglycerides, cholesterol),
    - Serum albumin and prealbumin concentrations,
    - CRP concentrations.
    In order to assess the impact of
    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 No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Collections of biological samples to perform further researches aimed to improve the knowledge on the peritoneal membrane :
    - Whole blood samples for genetic research
    - urine, serum and dialysis effluent samples
    - peritoneal biopsies
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Simple dose icodextrin
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    The end of the study will occur 12 months after the last patient last visit because a follow-up contact is planned after the study completion by the patient. This contact will be done 12 months after the end of the study to know when the peritoneal dialysis was finaly stopped by the patient and the current modality of dialysis.
    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 months6
    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 months6
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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)
    After its discontinuation or completion, the patient will be followed with the expected normal care for its condition
    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 Decision2012-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-28
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