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    Summary
    EudraCT Number:2021-006789-19
    Sponsor's Protocol Code Number:NephroD_2021
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-02-11
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-006789-19
    A.3Full title of the trial
    Efficacy comparison of two doses of vitamin D3 in critically ill patients undergoing continuous renal replacement therapy - NephroD
    Porównanie skuteczności dwóch dawek witaminy D3 u pacjentów krytycznie chorych poddanych ciągłej terapii nerkozastępczej – NephroD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy comparison of two doses of vitamin D3 in critically ill patients undergoing continuous renal replacement therapy - NephroD
    Porównanie skuteczności dwóch dawek witaminy D3 u pacjentów krytycznie chorych poddanych ciągłej terapii nerkozastępczej – NephroD
    A.3.2Name or abbreviated title of the trial where available
    NephroD
    A.4.1Sponsor's protocol code numberNephroD_2021
    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 SponsorUSK w Opolu
    B.1.3.4CountryPoland
    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 supportABM, konkurs na działalność badawczo-rozwojową w zakresie niekomercyjnych badań klinicznych ABM/2020/1
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUSK w Opolu
    B.5.2Functional name of contact pointTomasz Czarnik
    B.5.3 Address:
    B.5.3.1Street AddressAl. Wincentego Witosa 26
    B.5.3.2Town/ cityOpole
    B.5.3.3Post code45-401
    B.5.3.4CountryPoland
    B.5.4Telephone number0048669 906 333
    B.5.5Fax number00487745 20 303
    B.5.6E-mailtomasz.czarnik@usk.opole.pl
    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 Devikap 15 000 IU/ml, płyn doustny
    D.2.1.1.2Name of the Marketing Authorisation holderZakłady Farmaceutyczne POLPHARMA S.A
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameDevikap
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNColecalciferol
    D.3.9.1CAS number 67-97-0
    D.3.9.4EV Substance CodeSUB06794MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Vitamin D3 deficiency
    niedobór witaminy D3
    E.1.1.1Medical condition in easily understood language
    Vitamin D3 deficiency
    niedobór witaminy D3
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10047626
    E.1.2Term Vitamin D deficiency
    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
    To evaluate and compare the effect of two different supplementation doses of vitamin D3 (25 (OH) D3) - 500,000 IU and 750,000 IU on the serum concentration of 25 (OH) D3 administered once enterally (through a gastric tuber or orally) in ICU patients with severe vitamin D3 deficiency undergoing continuous renal replacement therapy.
    E.2.2Secondary objectives of the trial
    - Assessment and comparison of the effect of two different doses of vitamin D3 supplementation on:
    *the mortality in ICU patients undergoing continuous renal replacement therapy,
    *the duration of ICU treatment in patients undergoing continuous renal replacement therapy,
    *the sepsis-related organ failure (SOFA) scale in ICU patients undergoing continuous renal replacement therapy,
    *the duration of catecholamine supply in ICU patients undergoing continuous renal replacement therapy.
    - To evaluate the correlation between the CRRT duration in hours from the moment of the investigational medicinal product administration until the visit 4 start and the serum vitamin D concentration in both treatment arms.
    - To evaluate the correlation between total gastric residual volume (GVR) in milliliters from the investigational medicinal product administration until the visit 4 start and the serum vitamin D concentration in both treatment arms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Presence of at least one of the following indications for implementation of CRRT by CVVHDF or CVVHF (Clinical Practice Guideline for Acute Kidney Injury):
    - replacement of non-functioning kidney function when acute kidney injury occurs
    - hyperkalemia
    - metabolic acidosis
    - pulmonary edema
    - complications of uremia (hemorrhagic diathesis, pericarditis)
    - hypervolaemia
    - Renal function support (control of goiter, acid-base, ion balance)
    2. organ failure score (SOFA) of at least 5 at the time of qualification for the study
    3. patient age >18 years
    4. 25(OH)D3 serum concentration ≤12.5 ng/ml - test performed by the local laboratory of the participating hospital
    5. Properly managed enteral nutrition (through a gastric tuber or orally) at any dose.
    E.4Principal exclusion criteria
    1. acute or advanced chronic liver failure (estimated by clinical presentation and biochemical markers: serum bilirubin, serum AST and ALT, high AST/ALT serum ratio, glycemia, INR value)
    2. hypercalcemia (total calcium >11 mg/dL or >2,7mmol/L )
    3. Any parathyroid disease
    4. KDIGO classification of end-stage renal disease
    5. Patients undergoing plasmapheresis, extracorporeal membrane oxygenation (ECMO), extracorporeal carbon dioxide elimination (ECCO2R)
    6. Patients who, in the opinion of the investigator, do not have a good chance of surviving the 72 hour period after study entry
    7. history of kidney stones or de novo renal calculi
    8. patient eligible for futile therapy avoidance protocol
    9. pregnancy
    10. sarcoidosis
    11. risk of impaired intestinal absorption in critical illness associated with at least one of the mentioned: impaired intestinal motility and delayed gastric emptying, constipation, diarrhea, intestinal hypoperfusion in shock, intoxication with subsequent intestinal edema after fluid resuscitation, changes in the intestinal microbiome.
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of patients with 25(OH)D3 serum levels ≥30 ng/mL on days 3 and 7 after vitamin D3 administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be formally summarized upon completion of the study
    E.5.2Secondary end point(s)
    - Number of patients who died on day 28 and day 90 after administration of vitamin D3 preparation.
    - Duration of treatment in the ICU of patients receiving vitamin D3 preparation.
    - SOFA score on day 3 and day 7 in patients receiving vitamin D3 preparation.
    - Duration of catecholamine supply in patients receiving vitamin D3.
    - The CRRT duration in hours from the investigational medicinal product administration until the visit 4 start.
    - Total gastric residual volume in milliliters from the investigational medicinal product administration until the visit 3 start.



    Safety Assessment Endpoints:
    - Percentage of patients who achieved toxic serum vitamin D3 concentrations (25(OH)D3 ≥150 ng/mL) on Days 3 and 7.
    - Percentage of patients who achieved a serum total calcium concentration (>11 mg/dL) on Days 3 and 7.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Will be formally summarized upon completion of 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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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
    The same IMP given to the patient at a different dose
    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 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
    LVLS (Last Visit Last Subject)
    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 days12
    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: 138
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 138
    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 2022-02-11. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Unconscious patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state138
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 138
    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)
    None
    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 Decision2022-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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