Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-01-01 @ 4:44 PM
Study NCT ID:
NCT07020104
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Skin Sodium Accumulation in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'C060343', 'term': 'lercanidipine'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007783', 'term': 'Lactones'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The association between tissue sodium accumulation and cardiovascular parameters, body composition, skin hydration and transepidermal water loss, renal and cardiovascular outcome will be studied in 60 CKD patients (A).\n\n14 of the 60 CKD patients will be randomized to a 2-week low sodium diet and a 2-week high sodium diet in an open-label cross-over manner (B).\n\n12 CKD patients will receive 3 antihypertensive agents (spironolactone, lercanidipine and hydrochlorothiazide) in random order for 6 weeks (C).\n\n12 of the 60 CKD subjects will be randomized to a 4 week increased water intake and 4 week habitual water intake (D).\n\nAll the intervention mentioned above are separated by a washout period of at least 2 weeks between interventions.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2039-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Skin water content at baseline (A)', 'timeFrame': '0', 'description': 'Skin water content will be measured using the 7T H-MRI'}, {'measure': 'Muscle water content at baseline (A)', 'timeFrame': '0 week', 'description': 'Muscle water content will be measured using the 7T H-MRI'}, {'measure': 'Change from baseline in skin water content (B/C/D)', 'timeFrame': '2 weeks', 'description': 'Change in skin water content after sodium excretion, sodium intake and water intake intervention'}, {'measure': 'Change from baseline in muscle water content (B/C/D)', 'timeFrame': '2 weeks', 'description': 'Change in muscle water content after sodium excretion, sodium intake and water intake intervention'}, {'measure': 'Association between tissue sodium content and skin hydration (A)', 'timeFrame': '0 week', 'description': 'The skin hydration will be measured using the Corneometer® CM 825 probe'}, {'measure': 'Change from baseline in skin hydration (B/C/D)', 'timeFrame': '2 weeks', 'description': 'The skin hydration will be measured using the Corneometer® CM 825 probe'}], 'primaryOutcomes': [{'measure': 'Skin sodium content at baseline (A)', 'timeFrame': '0 week', 'description': 'Skin sodium content will be measured using the 7T sodium MRI'}, {'measure': 'Muscle sodium content at baseline (A)', 'timeFrame': '0 week', 'description': 'Muscle sodium content will be measured using the 7T sodium MRI'}, {'measure': 'Change from baseline in tissue sodium content after low and high sodium diet (B)', 'timeFrame': '2 weeks'}, {'measure': 'Change in tissue sodium content after treatment with hydrochloorthiazide, spironolacton and lercanidipine (C)', 'timeFrame': '6 weeks', 'description': 'To study the effect of hydrochloorthiazide, spironolacton and lercanidipine on tissue sodium content, to compare the effect among the various antihypertensive agents and to assess the effect of blood pressure regulation, increased renal sodium excretion and aldosteron blockade on tissue sodium content.'}, {'measure': 'Change from baseline in tissue sodium content after habitual and high water intake (D)', 'timeFrame': '4 weeks', 'description': 'To evaluate the effect of high and habitual water intake on tissue sodium content.'}, {'measure': 'Change from baseline in transepidermal water loss after habitual and high water intake (D)', 'timeFrame': '4 weeks', 'description': 'To evaluate the effect of high and habitual water intake on transepidermal water loss.'}, {'measure': 'Incidence of hyponatremia and hypervolemia (D)', 'timeFrame': '4 weeks', 'description': 'Safety of high water intake in CKD patients with eGFR between 15 and 30ml/min/1.73m2'}], 'secondaryOutcomes': [{'measure': 'Correlation between tissue sodium content and total vessel density (A)', 'timeFrame': '0 week', 'description': 'Correlation between tissue sodium content measured with 7T Na-MRI and total vessel density using Sidestream Dark Field imaging.'}, {'measure': 'Correlation between tissue sodium content and perfused vessel density (A)', 'timeFrame': '0 week', 'description': 'Correlation between tissue sodium content measured with 7T Na-MRI and perfused vessel density using Sidestream Dark Field imaging.'}, {'measure': 'Correlation between tissue sodium content and proportion of perfused vessels (A)', 'timeFrame': '0 week', 'description': 'Correlation between tissue sodium content measured with 7T Na-MRI and proportion of perfused vessels using Sidestream Dark Field imaging.'}, {'measure': 'Correlation between tissue sodium content and microvascular flow index (A)', 'timeFrame': '0 week', 'description': 'Correlation between tissue sodium content measured with 7T Na-MRI and microvascular flow index using Sidestream Dark Field imaging.'}, {'measure': 'Correlation between tissue sodium content and microvascular health score (A)', 'timeFrame': '0 week', 'description': 'Correlation between tissue sodium content measured with 7T Na-MRI and microvascular health score using Sidestream Dark Field imaging.'}, {'measure': 'Correlation between tissue sodium content and total pheripheral resistance (A)', 'timeFrame': '0 week', 'description': 'Total pheripheral resistance will be measured using the Nexfin device and tissue sodium content will be measured using the 7T Na-MRI'}, {'measure': 'Correlation between tissue sodium content and cardiac output (A)', 'timeFrame': '0 week', 'description': 'Cardiac output will be measured using the Nexfin device and tissue sodium content will be measured using the 7T Na MRI'}, {'measure': 'Correlation between tissue sodium content and transepidermal water loss (A)', 'timeFrame': '0 week', 'description': 'Transepidermal water loss will be measured with the Tewameter® TM Hex probe and tissue sodium content will be measured using the 7T Na MRI'}, {'measure': 'Correlation between tissue sodium content and office systolic and diastolic blood pressure (A)', 'timeFrame': '0 week', 'description': 'Tissue sodium content will be measured using the 7T sodium MRI'}, {'measure': 'Correlation between tissue sodium content and 24-hour systolic and diastolic blood pressure (A)', 'timeFrame': '0 week', 'description': 'Tissue sodium content will be measured using the 7T Na MRI'}, {'measure': 'Correlation between tissue sodium content and nightime blood pressure dipping pattern (A)', 'timeFrame': '0 week', 'description': "The nighttime blood pressure dipping pattern will be measured with a 24-hour blood pressure measurements. Patients will be classified as a 'dippers' when the nighttime systolic blood pressure and/or diastolic blood pressure falls \\>10% and \\<20% compared to daytime readings. Exteme dippers are described as those with blood pressure fall of at least 20%. Patients with blood pressure fall between 0 and 10% are classified as non-dippers."}, {'measure': 'Correlation between tissue sodium content and total body water (A)', 'timeFrame': '0 week', 'description': 'Total body water (liter) will be measured using the bioelectrical impendance analysis and tissue sodium content will be measured using the 7T Na MRI'}, {'measure': 'Correlation between tissue sodium content and quality of life (A)', 'timeFrame': 'At baseline and yearly during follow-up', 'description': 'Quality of life(QoL) will be measured with the Kidney Disease Quality of Life questionnaire at baseline and yearly during follow-up and tissue sodium comntent will be measured using the 7T Na MRI at baseline'}, {'measure': 'The correlation between tissue sodium content and traditional cardiovascular risk factors (A)', 'timeFrame': '15 years', 'description': 'In the cohort study, the correlation between tissue sodium content measured with 7T Na MRI and the known traditional cardiovascular risk factors will be studied.'}, {'measure': 'Change from baseline in plasma co-peptine concentrations (D)', 'timeFrame': '4 weeks', 'description': 'For waterintake intervention study'}, {'measure': 'Change from baseline in seated systolic and diastolic office blood pressure (B/C/D)', 'timeFrame': '2 weeks', 'description': 'Seated office systolic and diastolic blood pressure after interventions compared to baseline'}, {'measure': 'Change from baseline in 24-hour systolic and diastolic blood pressure (B/C/D)', 'timeFrame': '2 weeks', 'description': '24-hour systolic and diastolic blood pressure after interventions compared to baseline'}, {'measure': 'Change from baseline in percentage of patients with a night-time blood pressure dipping pattern (B/C/D)', 'timeFrame': '2 weeks', 'description': "Nighttime blood pressure dipping status will be measured with a 24-hour blood pressure measurements. Patients will be classified as a 'dippers' when the nighttime systolic blood pressure and/or diastolic blood pressure falls \\>10% and \\<20% compared to daytime readings. Exteme dippers are described as those with blood pressure fall of at least 20%. Patients with blood pressure fall between 0 and 10% are classified as non-dippers."}, {'measure': 'Change from baseline in transepidermal water loss (B/C/D)', 'timeFrame': '2 weeks', 'description': 'Transepidermal water loss will be measured with the Tewameter® TM Hex probe'}, {'measure': 'Change from baseline in total body water (B/C/D)', 'timeFrame': '2 weeks', 'description': 'Total body water will be measured using the bioelectrical impendance analysis'}, {'measure': 'Change from baseline in total vessel density (B/C/D)', 'timeFrame': '2 weeks', 'description': 'The total vessel density will be measured using Sidestream Dark Field imaging.'}, {'measure': 'Change from baseline in perfused vessel density (B/C/D)', 'timeFrame': '2 weeks', 'description': 'The perfused vessel density will be measured using Sidestream Dark Field imaging.'}, {'measure': 'Change from baseline in proportion of perfused vessel (B/C/D)', 'timeFrame': '2 weeks', 'description': 'The proportion of perfused vessels will be measured using Sidestream Dark Field imaging.'}, {'measure': 'Change from baseline in microvascular flow index (B/C/D)', 'timeFrame': '2 weeks', 'description': 'The microvascular flow index will be measured using Sidestream Dark Field imaging.'}, {'measure': 'Change from baseline in microvascular health score (B/C/D)', 'timeFrame': '2 weeks', 'description': 'The microvascular health score will be measured using Sidestream Dark Field imaging.'}, {'measure': 'Change from baseline in total peripheral resistance (B/C/D)', 'timeFrame': '2 weeks', 'description': 'The total pheripheral resistance will be measured using the Nexfin device'}, {'measure': 'Change from baseline in cardiac output (B/C/D)', 'timeFrame': '2 weeks', 'description': 'The cardiac output will be measured using the Nexfin device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Skin sodium', 'Sodium MRI', 'CKD', 'Prognosis', 'Cardiovascular event', 'Renal event', 'Quality of life', 'Tissue sodium'], 'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'This project consists of four substudies: a cohort study (A) and a sodium intake intervention (B) and a sodium excretion intervention (C) and a water intervention study (D).\n\nThe main objective of the cohort study (A) is to investigate the prognostic implications of tissue sodium accumulation in CKD patients. The primary objective of the sodium intervention studies is to study the effect of high and low sodium intake (B) and increased renal sodium excretion (C) on tissue sodium content. The main objective of the water intervention study (D) is to investigate the effect of increased and habitual water intake on tissue sodium content and transepidermal water loss.', 'detailedDescription': 'Cohort study (A):\n\n60 CKD patients (eGFR 15 - 60 ml/min/1.73m2) are included in this cohort study. At the start of the study the association between tissue sodium content and micro-and macrovascular function will be evaluated. These patients will be followed up to investigate the association between tissue sodium content, quality of life and renal and cardiovascular events.\n\nSodium intake intervention (B):\n\nA subgroup of 14 CKD patients (eGFR 15 - 60 ml/min/1.73m2) will be randomized to a 2-week low sodium diet and a 2-week high sodium diet in a cross-over study.\n\nSodium excretion intervention (C):\n\nA subgroup of 12 CKD patients (eGFR 30 - 60 ml/min/1.73m2) with hypertension will be randomized to receive 6 weeks of treatment with hydrochlorothiazide, spironolactone and lercanidipine in a randomized open-label cross-over trial.\n\nWater intake intervention (D) A subgroup of 12 CKD patients (with eGFR 15-30 ml/min/1.73m2, hypertension and fasting morning urine osmolality \\< 425 mOsm/kg for men and \\< 400 mOsm/kg for women) will be randomized to a 4-week habitual water intake and 4-week increased water intake in a cross-over study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Chronic kidney disease with an eGFR between 15 and 60 ml/min/1.73m2.\n2. Stable diuretic and antihypertensive treatment for the previous 6 weeks.\n\nAdditional inclusion criteria for the sodium excretion intervention 1. Office systolic blood pressure (SBP) \\>135 mmHg\n\nAdditional inclusion criteria for the water intervention\n\n1. Chronic kidney disease with an eGFR between 15 and 29 ml/min/1.73m2\n2. Office blood pressure ≥140/90 mmHg or use of antihypertensive medication\n3. Fasting morning urine osmolality \\<425 mOsm/kg for men and \\< 400 mOsm/kg for women\n\nExclusion Criteria:\n\n1. Age \\<18 years.\n2. The patient is expected to start renal replacement therapy or is planned to receive a kidney transplantation within 3 months.\n3. An active diagnosis of nephrotic syndrome at inclusion.\n4. (Recurrent) acute glomerulonephritis within 1 year prior to the study.\n5. Salt losing nephropathy.\n6. Use of oral or intravenous glucocorticoids with an equivalent of prednisolone \\>5mg/day.\n7. Contra-indication for MRI.\n8. Cardiovascular event/ surgery in the previous 3 months.\n9. Pregnant women, women of child bearing age planning to conceive for the study duration, women of child bearing age without contraception.\n10. Participation in other (pharmacological) intervention studies.\n11. Presence of significant comorbidities with a life expectancy of less than 1 year.\n12. Disorder that compromises the participants' ability to give truly informed consent for participation in this study.\n13. Patients with an active infection and/or auto-immune diseases with involvement of the lower extremities.\n14. Any other issues that in opinion of the investigator could be harmful to the subject or compromise interpretation of the data.\n\nAdditional exclusion criteria for the sodium intake intervention\n\n1\\. Chronic use of NSAID\n\nAdditional exclusion criteria for the sodium excretion intervention\n\n1. Serum potassium concentration \\>5.0 mmol/l.\n2. eGFR \\<30 ml/min/1.73m2\n3. Uncontrolled hypertension (\\>180/100 mmHg)\n4. Severe heart failure with left ventricular ejection fraction \\<30%.\n5. Contra-indication for investigational drugs.\n6. Severe symptoms of (orthostatic) hypotension.\n7. Patients with obstruction of the outflow tract of the left ventricle such as aortic valve stenosis.\n8. Refractory hypokalemia, hyponatremia or hypercalcemia.\n9. Severe liver insufficiency Child Pugh B/C\n10. Chronic use of NSAID.\n\nAdditional exclusion criteria for the water intake intervention\n\n1. Recent history of severe hyponatremia (outpatient plasma sodium \\< 130 mmol/L in the last 6 months)\n2. Plasma sodium \\<135 mmol/L at screening\n3. History of heart failure\n4. Use of lithium, vasopressin analoga, vasopressin antagonists, oral or intravenous glucocorticoids, thiazide diuretics.\n5. 24-hour urine volume \\> 2L\n6. Chronic use of NSAID"}, 'identificationModule': {'nctId': 'NCT07020104', 'acronym': 'SKIN-CKD', 'briefTitle': 'The Role of Skin Sodium Accumulation in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': 'The Role of Skin Sodium Accumulation in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'NL82810.018.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium excretion intervention (C)', 'description': 'In this intervention group, the patients will receive three antihypertensive drugs in a randomized order. Thus the following orders are possible:\n\n1. Lercanidipine - Spironolactone - Hydrochlorothiazide\n2. Lercanidipine - Hydrochlorothiazide - Spironolactone\n3. Hydrochlorothiazide - Lercanidipine - Spironolactone\n4. Hydrochlorothiazide - Spironolactone - Lercanidipine\n5. Spironolactone - Lercanidipine - Hydrochlorothiazide\n6. Spironolactone - Hydrochlorothiazide- Lercanidipine', 'interventionNames': ['Drug: Hydrochlorothiazide', 'Drug: Spironolactone', 'Drug: Lercanidipine']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium intake intervention (B)', 'description': 'In this intervention group, the patients will receive two sodium diets in a randomized order. The following orders are possible:\n\n1. High sodium intake- Low sodium intake\n2. Low sodium intake- High sodium intake', 'interventionNames': ['Dietary Supplement: High sodium dietary intake (>200mmol/l)', 'Dietary Supplement: Low sodium dietary intake (<50mmol/l)']}, {'type': 'EXPERIMENTAL', 'label': 'Water intake intervention (D)', 'description': 'In this intervention group, the patients will be prescribed two water interventions in a randomized order. The following orders are possible: 1. High water intake- Habitual water intake 2. Habitual water intake- High water intake', 'interventionNames': ['Dietary Supplement: High water intake', 'Dietary Supplement: Habitual water intake']}], 'interventions': [{'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'description': 'Each patient will receive 1 tablet of hydrochlorothiazide 12.5mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dosage is doubled to 2 tablets of hydrochlorothiazide 12.5mg once daily for the following 3 weeks.\n\nIf the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.', 'armGroupLabels': ['Sodium excretion intervention (C)']}, {'name': 'Spironolactone', 'type': 'DRUG', 'description': 'Each patient will receive 1 tablet of spironolacton 12.5mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dose is doubled to 2 tablets of spironolacton 12.5mg once daily for the following 3 weeks.\n\nIf the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.', 'armGroupLabels': ['Sodium excretion intervention (C)']}, {'name': 'Lercanidipine', 'type': 'DRUG', 'description': 'Each patients will receive 1 tablet of lercanidipine 10mg once a day for the first 3 weeks of the drug cycle. If clinical and biochemical parameters allow, the dose is doubled to 2 tablets of lercanidipine 10mg once daily for the following 3 weeks.\n\nIf the laboratory results and clinical parameters do not allow dose intensification, the initial dosage will be continued during the second half of the drug cycle.', 'armGroupLabels': ['Sodium excretion intervention (C)']}, {'name': 'High sodium dietary intake (>200mmol/l)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The patients will receive a 2-week high sodium diet. The patients will receive dietary advice to achieve this goal of \\>200mmol/l sodium (\\>12g salt) intake per day.', 'armGroupLabels': ['Sodium intake intervention (B)']}, {'name': 'Low sodium dietary intake (<50mmol/l)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The patients will receive a 2-week low sodium diet. The patients will receive dietary advice to achieve this goal of \\<50mmol/l sodium (\\<3g salt) intake per day.', 'armGroupLabels': ['Sodium intake intervention (B)']}, {'name': 'High water intake', 'type': 'DIETARY_SUPPLEMENT', 'description': 'During the increased water intake period, the patients will be instructed to drink 1 L more than their mean 24-hour urine volume at screening and baseline.', 'armGroupLabels': ['Water intake intervention (D)']}, {'name': 'Habitual water intake', 'type': 'DIETARY_SUPPLEMENT', 'description': 'During this part of the intervention, the patients will be instructed to maintain their habitual water intake.', 'armGroupLabels': ['Water intake intervention (D)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam-Zuidoost', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rik Olde Engberink, MD,PhD', 'role': 'CONTACT', 'email': 'r.h.oldeengberink@amsterdamumc.nl', 'phone': '+31 0205669111', 'phoneExt': '27445'}, {'name': 'Sanédy Simon, MD', 'role': 'CONTACT', 'email': 's.s.a.simon@amsterdamumc.nl', 'phone': '+31 0205661930'}, {'name': 'Rik Olde Engberink, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sanédy Simon, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.3075, 'lon': 4.97222}}], 'centralContacts': [{'name': 'Rik Olde Engberink, MD, PhD', 'role': 'CONTACT', 'email': 'r.h.oldeengberink@amsterdamumc.nl', 'phone': '+31 0205669111', 'phoneExt': '27445'}, {'name': 'Sanédy Simon, MD', 'role': 'CONTACT', 'email': 's.s.a.simon@amsterdamumc.nl', 'phone': '0205661930'}], 'overallOfficials': [{'name': 'Rik Olde Engberink, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC, location AMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared with other researcher'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Kidney Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Internist-nephrologist, clinical pharmacologist', 'investigatorFullName': 'Rik Olde Engberink', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}