Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT07029503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swedish Cardiac And Renal Failure Study-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Transthoracic Echocardiography (TTE) analysis will take place retrospectively in a blinded manner'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'ABA-design with a 12-week baseline, a 12-week intervention, and a 12-week withdrawal period. Two observational periods are chosen due to the high risk of natural clinical deterioration, even over a relatively short timeframe, and to enable within-participant comparison of outcome slopes across phases.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-02', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the scores at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'Overall summary score between 0 and 100 (0 = very poor health status and 100 = excellent health status)'}, {'measure': 'Six-Minute Walk Test (6MWD)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'Meters walked during six minutes'}, {'measure': 'N-terminal pro b-type natriuretic peptide (NTpro-BNP)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in ng/L'}, {'measure': 'eGFR', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'According to the revised Lund-Malmö method in ml/min/1.73 m2'}, {'measure': 'Urine albumine-creatinine ratio', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in mg/mol'}, {'measure': 'Interventricular septal diameter in diastole (IVSd)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in mm, as assessed by TTE'}, {'measure': 'Left ventricular internal diameter in diastole (LVIDd)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in mm, as assessed by TTE'}, {'measure': 'Posterior wall diameter (PWd)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in mm, as assessed by TTE'}, {'measure': 'Left ventricular mass index (LVMi)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in g/m2, as assessed by TTE'}, {'measure': 'Relative wall thickness (RWT)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in %, as assessed by TTE'}, {'measure': 'Stroke volume index (SVI)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in ml/m2, as assessed by TTE'}, {'measure': 'Cardiac index (CI)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in l/min/m2, as assessed by TTE'}, {'measure': 'Ejection time', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in ms, as assessed by TTE'}, {'measure': 'Indexed left atrial volume (LAVi)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in ml/m2, as assessed by TTE'}, {'measure': 'Left atrial (LA) strain', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in %, as assessed by TTE'}, {'measure': 'Indexed left ventricular end diastolic volume (LVEDVi)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in ml/m2, as assessed by TTE'}, {'measure': 'Indexed left ventricular end systolic volume (LVESVi)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in ml/m2, as assessed by TTE'}, {'measure': 'Left ventricular (LV) EF', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in %, as assessed by TTE'}, {'measure': 'Left ventricular global longitudinal strain (LVGLS)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in %, as assessed by TTE'}, {'measure': 'E/A (early/late ventricular filling velocity)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'ratio, as assessed by TTE'}, {'measure': 'S/D (systolic/diastolic pulmonary vein flow velocity)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'ratio, as assessed by TTE'}, {'measure': 'Isovolumetric contraction velocity (IVCV)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in m/s, as assessed by TTE'}, {'measure': 'Isovolumetric relaxation velocity (IVRV)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in m/s, as assessed by TTE'}, {'measure': 'Isovolumetric relaxation time (IVRT)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in ms, as assessed by TTE'}, {'measure': 'Septal S´', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in cm/s, as assessed by TTE'}, {'measure': 'Lateral S´', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in cm/s, as assessed by TTE'}, {'measure': 'Septal É', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in cm/s, as assessed by TTE'}, {'measure': 'Lateral É', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in ms, as assessed by TTE'}, {'measure': 'Tricuspid annular plane systolic excursion (TAPSE)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in mm, as assessed by TTE'}, {'measure': 'Right ventricular (RV) strain', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in %, as assessed by TTE'}, {'measure': 'RV S´', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in cm/s, as assessed by TTE'}, {'measure': 'Systolic pulmonary arterial pressure (SPAP)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in mmHg, as assessed by TTE'}, {'measure': 'Myocardial work index (MWI)', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in mmHg%, as assessed by TTE'}, {'measure': 'Tei index', 'timeFrame': 'At the end of the 12-week eplerenone treatment period, compared with the values at the end of the 12-week baseline period and the end of the 12-week withdrawal period', 'description': 'in %, as assessed by TTE'}], 'primaryOutcomes': [{'measure': 'The primary endpoint is the proportion of participants who complete the treatment period with and without the need to use a potassium binder', 'timeFrame': 'Between the first and final day of the 12-week eplerenone treatment period', 'description': 'Without eplerenone interruption/discontinuation due to safety reasons, with and without SZC'}], 'secondaryOutcomes': [{'measure': 'The occurrence of plasma potassium (P-K) ≥ 5.6 and ≥ 6.0', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Yes/no'}, {'measure': 'Hospitalization for hyperkalemia', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Primary or co-primary reason, yes/no'}, {'measure': 'The occurrence of P-K < 3.0', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Yes/no'}, {'measure': 'Hospitalization for hypokalemia', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Primary or co-primary reason, yes/no'}, {'measure': 'Decrease in eGFR of ≥ 30% and ≥ 50%', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'According to the revised Lund-Malmö method in ml/min/1.73 m2, compared to the start of each study period, yes/no'}, {'measure': 'Hospitalization for renal failure', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Primary or co-primary reason, yes/no'}, {'measure': 'Initiation of dialysis', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Yes/no'}, {'measure': 'Participant-reported lightheadedness due to orthostatic hypotension as judged by the investigator', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Yes/no'}, {'measure': 'Participant-reported syncope', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Yes/no'}, {'measure': 'Any participant-reported side effect', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Yes/No'}, {'measure': 'Hospitalization for heart failure', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Primary or co-primary reason, yes/no'}, {'measure': 'All-cause hospitalization', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Yes/no'}, {'measure': 'Cardiovascular death', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Primary reason, yes/no'}, {'measure': 'All-cause death', 'timeFrame': 'Between the first and final day of each of the three 12-week study periods', 'description': 'Yes/no'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HFrEF - Heart Failure with Reduced Ejection Fraction', 'Chronic kidney disease', 'Heart failure', 'Chronic heart failure', 'HFrEF', 'CKD', 'Renal dysfunction', 'Kidney dysfunction', 'Renal impairment', 'Advanced', 'Severe', 'Mineralocorticoid receptor antagonists', 'MRA', 'Eplerenone', 'Sodium Zirconium Cyclosilicate', 'SZC'], 'conditions': ['HFrEF - Heart Failure With Reduced Ejection Fraction', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Previous studies have shown that patients with heart failure with reduced pumping function and preserved kidney function experience improved symptoms, longer survival, and fewer hospitalizations when treated with medications such as eplerenone. However, individuals with impaired kidney function have been excluded from these trials due to concerns about potential adverse effects on potassium levels, kidney function, and possibly also blood pressure. As a result, clear treatment recommendations for this high-risk group are lacking.\n\nIn recent years, however, background therapies have been modernized and are now associated with a lower risk of potassium disturbances. Preliminary data also suggest that patients with impaired kidney function may benefit from eplerenone treatment. However, confirmation through dedicated studies is needed.\n\nThe primary objective of this pilot trial is to assess the feasibility and safety of eplerenone in patients with heart failure with reduced pumping function and impaired kidney function. Treatment effectiveness will also be explored.', 'detailedDescription': 'Virtually all major trials in heart failure with reduced ejection fraction (HFrEF), including those investigating mineralocorticoid receptor antagonists (MRAs) such as eplerenone, have excluded patients with severe chronic kidney disease (CKD). This exclusion has likely been driven by concerns over the risks of hyperkalemia and worsening renal function (WRF). However, post-hoc analyses of these major trials, along with data from registries and cohort studies, suggest that patients with more advanced renal impairment may still derive an overall benefit from MRA treatment.\n\nThe objective of this pilot trial is to evaluate the feasibility and safety of eplerenone in patients with HFrEF and severe CKD. An exploratory analysis of efficacy will also be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The participant has given their written consent to participate\n* A diagnosis of HFrEF according to current criteria, for at least three months before the screening visit\n* Echocardiography within 24 months of the screening visit with ejection fraction ≤ 40%\n* New York Heart Association class II-III\n* Optimally treated and stable HFrEF (according to the investigator) since at least four weeks before the screening visit. Treatment should include beta-blockers, sodium/glucose co-transporter 2 inhibitors, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers if eGFR ≥ 20 ml/min/1.73m2 according to the revised Lund-Malmö method. Participants should also have cardiac resynchronization therapy or an implantable cardioverter-defibrillator if the indication exists according to current guidelines\n* eGFR \\< 30 ml/min/1.73m2 according to the revised Lund-Malmö method at least once during the 12 months before the screening visit, and eGFR \\< 45 ml/min/1.73m2 at the time of inclusion\n\nExclusion Criteria:\n\n* P-K ≥ 5.6\n* eGFR \\< 10 ml/min/1.73m2 according to the revised Lund-Malmö method\n* Ongoing/planned dialysis\n* Systolic blood pressure \\< 90 mmHg\n* Uncontrolled hypertension as judged by the investigator\n* Severe hepatic impairment (Child-Pugh C)\n* History of, or planned, heart transplantation or left ventricular assist device\n* Unwillingness to comply with highly effective contraceptive methods, or ongoing/planned pregnancy, or breastfeeding\n* Previous allergic reaction to an MRA or a potassium binder\n* Ongoing treatment with lithium, cyclosporine, tacrolimus, nonsteroidal anti-inflammatory drugs, trimethoprim, or strong CYP3A inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, and nefazodone) or inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's Wort)\n* QTc(f) ≥ 550 msec, history of QT prolongation associated with any medication requiring medication discontinuation, or congenital long QT syndrome\n* Uncontrolled arrhythmia as judged by the investigator\n* Acute cardiac hospitalization or procedure within four weeks before inclusion\n* Not suitable as judged by the investigator (presumed inability to participate, severe or terminal co-morbidity, and expected survival \\< 12 months)\n* Previously enrolled in this trial or participation in another trial not approved for co-enrollment"}, 'identificationModule': {'nctId': 'NCT07029503', 'acronym': 'SCARF-1', 'briefTitle': 'Swedish Cardiac And Renal Failure Study-1', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Swedish Cardiac And Renal Failure Study-1 (SCARF-1): An Open-Label Pilot Trial to Evaluate the Feasibility, Safety and Efficacy of Eplerenone in Patients With Heart Failure With Reduced Ejection Fraction and Severe Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'SCARF-1'}, 'secondaryIdInfos': [{'id': '2025-520550-11-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-arm', 'description': 'Eplerenone', 'interventionNames': ['Drug: Eplerenone']}], 'interventions': [{'name': 'Eplerenone', 'type': 'DRUG', 'otherNames': ['Inspra®'], 'description': 'Participants will receive eplerenone 25 mg once daily or every other day, based on baseline potassium levels, eGFR, systolic blood pressure, and concomitant use of weak or moderate CYP3A4 inhibitors.\n\nThe study will implement a safety protocol with predefined procedures for managing significant hyperkalemia, worsening renal function, and hypotension. These will include temporary or permanent dose reduction or discontinuation of eplerenone, and, if necessary, administration of the potassium binder sodium zirconium cyclosilicate (SZC, Lokelma®).', 'armGroupLabels': ['Single-arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'contacts': [{'name': 'Carl Haggård, MD, PhD', 'role': 'CONTACT', 'email': 'carl.haggard@regionstockholm.se', 'phone': '0046735574724'}, {'name': 'Krister Lindmark, MD, PhD', 'role': 'CONTACT', 'email': 'krister.lindmark@regionstockholm.se', 'phone': '00467028888285'}, {'name': 'Carl Haggård, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Krister Lindmark, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karl Wärnberg, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Cardiology, Danderyd Hospital, Karolinska Institutet', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Carl Haggård, MD, PhD', 'role': 'CONTACT', 'email': 'carl.haggard@regionstockholm.se', 'phone': '0046735574724'}, {'name': 'Krister Lindmark, MD, PhD', 'role': 'CONTACT', 'email': 'krister.lindmark@regionstockholm.se', 'phone': '00467028888285'}], 'overallOfficials': [{'name': 'Krister Lindmark, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinska Institutet'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'The IPD and supporting information will be shared after publication of the results in a peer-reviewed medical journal, and will be available for a minimum of 25 years therafter.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data with approved ethical permission. All requests will be evaluated, but this does not mean all requests will be shared.', 'accessCriteria': 'Access to IPD and supporting information may be granted to qualified researchers whose intended use is to evaluate the trial, provided that participant anonymity is maintained.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Carl Haggård', 'investigatorAffiliation': 'Karolinska Institutet'}}}}