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    Summary
    EudraCT Number:2020-000695-38
    Sponsor's Protocol Code Number:2020-000695-38
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-05
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-000695-38
    A.3Full title of the trial
    Healthy diet rich in potassium containing fruits, vegetables and nuts to chronic kidney disease patients thought the use of sodium zirconium cyclosilicate: A Feasibility Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Healthy diet containing fruits, vegetables and nuts to patients with renal insufficiency thought the use of potassium binder (sodium zirconium cyclosilicate): A Study Test
    A.4.1Sponsor's protocol code number2020-000695-38
    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 SponsorKarolinska Universitetssjukhuset
    B.1.3.4CountrySweden
    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 supportAstra Zeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institutet
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska University Hospital, M99
    B.5.3.2Town/ cityHuddinge
    B.5.3.3Post codeSE-14186
    B.5.3.4CountrySweden
    B.5.4Telephone number46858582532
    B.5.6E-mailpeter.stenvinkel@ki.se
    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 Lokelma
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, SE-151 85 Södertälje
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameLokelma
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    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.3.9.3Other descriptive nameSODIUM ZIRCONIUM CYCLOSILICATE
    D.3.9.4EV Substance CodeSUB180392
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 g
    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) 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.IMP: 2
    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 Lokelma
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, SE-151 85 Södertälje
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameLokelma
    D.3.4Pharmaceutical form Powder for oral solution in sachet
    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.3.9.3Other descriptive nameSODIUM ZIRCONIUM CYCLOSILICATE
    D.3.9.4EV Substance CodeSUB180392
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 g
    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) 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
    Chronic kidney disease, stages 4 and 5 of the disease
    E.1.1.1Medical condition in easily understood language
    Renal insufficiency
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test whether chronic kidney disease patients on stages 4 and 5 of the disease can be safely prescribed a healthy diet with increased amount of potassium by concomitant use of potassium-lowering medication SZC to show improvements in patient´s satisfaction, symptoms and adherence to the target energy and protein recommendations.
    E.2.2Secondary objectives of the trial
    Investigate the impact of implementing a healthy diet rich in potassium - combined with use of potassium-lowering medication to maintain plasma potassium within 3.5 to 5.0 mmol/L - in controlling plasma potassium, improving quality of life, ameliorating intestinal obstipation, maintain the dosage antihypertensives with blockade of renin-angiotensin-aldosterone system, diminishing inflammation, better control of phosphate and p-carbon dioxide levels and leading to a more healthy microbiota.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed informed consent prior to any study specific procedures;
    2. Female and/or male patients;
    3. Age between 18 to 85 years old;
    4. Patients with chronic kidney disease under regular treatment at the outpatient clinic;
    5. Glomerular filtration rate below 29 ml/min/1.73 m2 (stage 4 and 5 of the disease) and not on dialysis;
    6. Plasma potassium ≥ 5.1 mmol/L at baseline or patients using of sodium polystyrene sulfonate (SPS) 1 month prior to inclusion to decrease the potassium plasma levels who develops hyperkalemia after sodium polystyrene sulfonate is discontinued;
    7. Negative pregnancy test (urine or serum) for female subjects of childbearing potential;
    8. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of SZC to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
    E.4Principal exclusion criteria
    1. Use of other potassium-lowering agent then SPS (loop-diuretics not included);
    2. Participation in another clinical study with an investigational product during the last 3 months prior to inclusion;
    3. Plasma potassium > 6.5 mmol/L;
    4. Plasma potassium < 3.0 mmol/l at any visit;
    5. Likely to start dialysis within 2 months according to the clinical judgment from the nephrologist;
    6. Presence of inflammatory bowel syndrome;
    7. Lack of fluence in the Swedish language;
    8. Known hypersensitivity to SZC;
    9. Known history of drug or alcohol abuse within 1 year of screening;
    10. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding;
    11. History of QT prolongation associated with other medications that required discontinuation of that medication;
    12. Congenital long QT syndrome;
    13. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted;
    14. History of QT-prolongation: QTc(f) > 550 msec or uncontrolled atrial fibrillation.
    E.5 End points
    E.5.1Primary end point(s)
    1. Patient satisfaction: based on Renal Treatment Satisfaction Questionnaire (RTSQ).
    2. Symptoms: based on the symptoms list.
    3. Adherence to the dietary protein and energy targets: based on the 24-hour food recalls.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The following timepoints are the same for all primary endpoints:
    Baseline (Week 0), Week 3 (Beginning of healthy diet), Week 6 (End of Study, End of healthy Diet)
    E.5.2Secondary end point(s)
    1. Changes in plasma potassium
    2. % patients with normokalemia, defined as potassium 3.5-5.0 mmol/L
    3. Quality of life parameters: based on the RAND Short Form Health Survey (SF-36)
    4. Improvement of intestinal obstipation: based on the ROMA III questionnaire and Bristol stool score;
    5. Changes in inflammatory markers (C-reactive protein and interleukin-6), phosphate, P-carbon dioxide.
    6. Reduction of circulating levels of microbiota-derived uremic retention solutes, such as indoxyl-sulfate, p-cresyl sulfate and trimethylamine N-oxide.
    7. Maintaining the desired level of dosage of ACEIs and ARBs
    E.5.2.1Timepoint(s) of evaluation of this end point
    The following timepoints are the same for all secondary endpoints:
    Baseline (Week 0), Week 3 (End of stabilization phase and beginning of healthy diet phase), Week 6 (End of Study, End of healthy Diet).
    Potassium will assessed also after 48h of baseline, after 48 hours Starting Week 3 and in week 2 and week 5.
    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 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 No
    E.8.1.1Randomised No
    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.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.5The 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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 2020-05-05. 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 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 state36
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 36
    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)
    Sodium Zirconium Cyclosiclicaye (SZC) (Comercial name Lokelma) is a registered drug. Thus, continued treatment will be prescribed by physician in change of the patient and according to FASS and existing guidelines for management of high potassium
    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 Decision2020-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-10
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