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    Summary
    EudraCT Number:2012-001824-36
    Sponsor's Protocol Code Number:201201
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-11
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-001824-36
    A.3Full title of the trial
    ORAL SODIUM BICARBONATE SUPPLEMENTATION IN PATIENTS WITH CHRONIC METABOLIC ACIDOSIS AND CHRONIC KIDNEY DISEASE
    Orale Natriumbicarbonat Substitution bei Patienten mit chronischer metabolischer Azidose und chronischer Niereninsuffizienz
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ORAL SODIUM BICARBONATE SUPPLEMENTATION IN PATIENTS WITH CHRONIC METABOLIC ACIDOSIS AND CHRONIC KIDNEY DISEASE
    Orale Natriumbicarbonat Substitution bei Patienten mit chronischer metabolischer Azidose und chronischer Nieren-Erkrankung
    A.3.2Name or abbreviated title of the trial where available
    Oral SoBic supplementation in patients with CKD
    A.4.1Sponsor's protocol code number201201
    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 SponsorMedizinsiche Universität Wien, Klinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse
    B.1.3.4CountryAustria
    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 supportMedizinsiche Universität Wien, Klinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinsiche Universität Wien, Klinik für Innere Medizin III, Abteilung für Nephrologie und Dialyse
    B.5.2Functional name of contact pointAmbulanz für Nierenerkrankungen
    B.5.3 Address:
    B.5.3.1Street AddressWähringer Gürtel 18-20
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+431404004217
    B.5.5Fax number+431404004392
    B.5.6E-mailmartina.gaggl@meduniwien.ac.at
    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 Nephrotrans 840mg
    D.2.1.1.2Name of the Marketing Authorisation holderMedice Arneimittel Pütter GmbH & Co
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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, hard
    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 INNNatriumhydrogencarbonat
    D.3.9.1CAS number 144-55-8
    D.3.9.2Current sponsor code5424.01.00
    D.3.9.3Other descriptive nameSODIUM BICARBONATE
    D.3.9.4EV Substance CodeSUB12643MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number840
    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 classified to have chronic kidney disease of stage 3 and 4 and chronic metabolic acidosis (venous serum HCO3- of <21mml/L on 2 separate measurements at least 1 day apart) should be included into the study. The effect of sodium bicarbonate supplementation on renal function should be evaluated.
    Patienten mit chronischer Niereninsuffizienz im Stadium 3 und 4 and metabolischer Azidose (venöses Serum HCO3- unter 21mmol/L an 2 Messzeitpunkten mindestens einen Tag voneinander getrennt) sollen in diese Studie eingeschlossen werden. Der Effekt von einer Natriumbicarbonat-Therapie auf die Nierenfunktion soll evaluiert werden.
    E.1.1.1Medical condition in easily understood language
    Patients with advanced chronic kidney disease and chronic metabolic acidosis should be included into the study.
    Patienten mit einer chronisch eingeschränkter Nierenfunktion und einer chronischen metabolischen Azidose werden bei dieser Studie eingeschlossen.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10066569
    E.1.2Term Chronic acidosis
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Metabolic acidosis in chronic kidney disease is thought to be the result of an insufficient production of bicarbonate in the renal tubular system. Thus, the intervention of an oral exogenous bicarbonate supplementation to substitute the lacking endogenous bicarbonate seems to be rational. Patients with chronic kidney disease stage III and IV and chronic metabolic acidosis should be randomized to either receive a high dose of oral sodium bicarbonate with a serum target HCO3- level of 24±1 mmol/L or receive a rescue therapy of sodium bicarbonate with a serum target level of 20±1 mmol/L. After two years decline of renal function, as well as mortality rates and time of initiation of renal replacement therapy should be compared across study groups.
    Eine chronische metabolische Azidose ist eine häufige Folge einer eingeschränkten Nierenfunktion. Möglicherweise ist die Substitution von Natriumbicarbonat eine simple und kostengünstige Ergänzung zu der derzeit etablierten Therapie um die Progression bei Chronischer Niereninsuffizienz zu verringern. Patienten im CKD-Stadium 3 und 4 und einer metabolischen Azidose werden in 2 Gruppen eingeteilt, die entweder mittels Natriumbicarbonat auf einen HCO3 Wert von mindestens 24±1 mmol/L angehoben werden sollen oder stabil am Niveau von 20±1 mmol/L gehalten werden sollen. Nach 2 Jahren soll die Nierenfunktion der beiden Gruppen miteinander verglichen werden, sowie Mortalität und Zeit bis zum Beginn der Nierenersatztherapie.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the trail are the rate of adverse events, in particular the effect of the additional daily dietary sodium load on the arterial blood pressure.

    Sekundäre soll die Verträglichkeit beurteilt werden. Im Hinblick auf den zusätzlichen täglichen Natrium-Konsum durch die Studienmedikation soll hier besonders auf den arteriellen Blutdruck geachtet werden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 years.
    • Renal function (measured by eGFR-MDRD) between 60 and 15mL/min/ 1.73m2.
    • Venous serum HCO3- of <21mml/L on two consecutive measurements, at least one day apart.
    • Stable condition.
    • Alter ≥18 Jahre.
    • Nierenfunktion (eGFR-MDRD) zwischen 60 and 15mL/min/ 1.73m2.
    • Venöses Serum HCO3- of <21mml/L zu 2 Messzeitpunkten mindestens einen Tag von einander getrennt.
    • Stabiler klinischer Zustand.
    E.4Principal exclusion criteria
    • Malignant disease or <5years after a successfully treated malignant disease (except dermal malignancies and carcinoma in situ of the cervix declared to be cured).
    • Morbid obesity (BMI >40 kg/m2).
    • Chronic sepsis (C reactive protein > 10 mg/dL).
    • Immunosuppressive therapy of any kind.
    • Poorly controlled blood pressure (>150/90mmHg despite the use of 4 agents)
    • Overt congestive heart failure.
    • Known peanut and/or soy allergy.
    • Malignom oder <5 Jahre nach einer erfolgreichen Behandlung einer malignen Erkrankung (ausgenommen dermale Neoplasien und Carcinoma in situ der Cervix, die als geheilt gelten).
    • Morbide Adipositas (BMI >40 kg/m2).
    • Chronische Sepsis (C Reaktives Protein > 10 mg/dL).
    • Immunsuppressive Therapie
    • Schlecht eingestellte arterielle Hypertonie (>150/90mmHg trotz einer 4-fach Kombination aus Antihypertensiva)
    • Dekompensierte Herzinsuffizienz.
    • Bekannte Erdnuss- und/oder Sojaallergie.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the study is the effect of sodium bicarbonate supplementation on renal function (eGFR). Thus, the Null hypothesis suggests no difference in renal function across study groups after 2 years. On the contrary, a significantly higher eGFR in the interventional group compared to the control group confirms the alternative hypothesis.
    Der primäre Endpunkt der Studie ist der Effekt von Natriumbicarbonat auf die Nierenfunktion (eGFR). Die Nullhypothese besagt, dass es keinen Unterschied in der Nierenfunktion zwischen den beiden Studiengruppen nach 2 Jahren gibt. Die Alternativhypothese besagt, dass Patienten der Gruppe mit hochdosiertem Natriumbicarbonat im Vergleich zur Kontrollgruppe (niedrigdosiertes Natriumbicarbonat) eine signifikant bessere Nierenfunktion zeigen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 months
    Nach 24 Monaten
    E.5.2Secondary end point(s)
    Secondary end points are death rates between groups and the number of subjects proceeding to RRT (renal transplantation, hemodialysis, peritoneal dialysis) across groups. The alternative hypothesis suggests a significantly higher death rate and higher number of initiation of RRT, respectively, in the control group compared to the intervention group. The Null hypothesis confirms no difference in death rates and rates of initiation of RRT across study groups.
    Sekundäre Endpunkte sind Mortalität und der Beginn von Nierenersatztherapie. Die Nullhypothese besagt, dass die Mortalität und/ oder die Rate an Neubeginn von Nierenersatztherapie in beiden Gruppen gleich ist. Die Alternativhypothese besagt, dass die Mortalität und/ oder die Rate an Neubeginn von Nierenersatztherapie in der Interventionsgruppe signifikant niedriger ist, als in der Kontrollgruppe.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 24 months.
    Nach 24 Monaten
    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 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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.1.7.1Other trial design description
    Kontrolliert, randomisiert, nicht verblindet
    Controlled, randomized, open label
    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
    Niedrigdosiertes IMP
    Low dose of the IMP
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA0
    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 investigator has the right to close this study at any time. The trial will be terminated prematurely in cases of the occurrence of adverse events, so that the risk-benefit ratio is not acceptable, or if the number of dropouts is so high that proper completion of the trial cannot realistically be expected.
    Der Prüfarzt hat das Recht die Studie jederzeit vorzeitig abzubrechen, wenn durch das Auftreten von Nebenwirkungen (AEs) das Nutzen-Risiko Verhältnis nicht mehr akzeptabel ist oder durch eine zu hohe Anzahl an Studienabbrechern eine Auswertung der Studie nicht realistisch ist.

    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 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 2012-06-11. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 200
    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)
    No difference of the normal treatment of that condition
    Kein Unterschied zur Standardbehandlung dieser Patientengruppe
    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 Decision2012-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-12
    P. End of Trial
    P.End of Trial StatusOngoing
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