Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-01-20 @ 9:31 AM
Study NCT ID:
NCT03301558
Status:
WITHDRAWN
Last Update Posted:
2024-09-19
First Post:
2017-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017693', 'term': 'Sodium Bicarbonate'}], 'ancestors': [{'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'study not started due to organizational reasons', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-10-03', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Propensity of serum for calcification', 'timeFrame': '12 weeks', 'description': 'The primary outcome is change in the mean T50 values between different study phases (treatment vs. control).'}], 'secondaryOutcomes': [{'measure': 'Serum bicarbonate levels', 'timeFrame': '12 weeks', 'description': 'The secondary outcome is change of serum bicarbonate levels between different study phases.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplant; Complications']}, 'descriptionModule': {'briefSummary': 'This is a single-center, prospective, open-label, randomized, cross-over study.', 'detailedDescription': 'The primary hypothesis (H1) is that the T50 value will change between wash-out and high-dose (3000mg/d) sodium bicarbonate (Nephrotrans®) substitution.\n\nThe 0-hypothesis (H0) is that substitution of 3000 mg/d sodium bicarbonate (Nephrotrans®) has no effect on T50-values as compared to wash-out-phase.\n\nPatients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between.\n\nPatients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between. The study will start with an initial run-in wash-out phase, where all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care will be discontinued. Consequently, there will be a sodium bicarbonate treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3 days of duration. Patients will be followed up to 12weeks after randomization until the last study visit of the final wash-out phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* Prevalent (≥ 6 months after kidney transplantation) kidney transplant recipients\n* eGFR (CKD-EPI formula) between 10 and 50 ml/min/1.73 m²\n* Patient has provided informed consent prior to initiation of any study related procedure\n\nExclusion Criteria:\n\n* Allergy to sodium bicarbonate or any component of Nephrotrans®, namely soy or peanuts (reported cross-reactivity to peanuts has been reported in patients with soy-allergy).\n* Unstable clinical condition (e.g. uncontrolled heart failure, clinical uremia, uncontrolled hypertension, impending initiation of dialysis treatment…) as judged by the recruiting physician\n* Pregnant and nursing (lactating) women\n* Unwillingness to discontinue current medication with sodium bicarbonate\n* Unwillingness to discontinue antacids containing aluminum, calcium carbonate, magnesium, lactate, citrate, bicarbonate or mixtures thereof'}, 'identificationModule': {'nctId': 'NCT03301558', 'briefTitle': 'The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Elisabethinen Hospital'}, 'officialTitle': 'The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'KTR-Bic-T50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose sodium bicarbonate', 'description': 'Low dose 1500 mg sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take one capsule with breakfast, one with lunch and one with dinner (schedule 1-1-1).', 'interventionNames': ['Drug: Low dose sodium bicarbonate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Dose sodium bicarbonate', 'description': 'High dose 3000 mg of sodium bicarbonate (Nephrotrans®) per day (500mg tablets 3x/day) for 14 ± 3 days. The patients will be advised to take two capsules with breakfast, two with lunch and two with dinner (schedule 2-2-2).', 'interventionNames': ['Drug: High dose sodium bicarbonate']}], 'interventions': [{'name': 'Low dose sodium bicarbonate', 'type': 'DRUG', 'otherNames': ['Nephrotrans'], 'description': '1500 mg sodium bicarbonate', 'armGroupLabels': ['Low dose sodium bicarbonate']}, {'name': 'High dose sodium bicarbonate', 'type': 'DRUG', 'otherNames': ['Nephrotrans'], 'description': '3000 mg sodium bicarbonate', 'armGroupLabels': ['High Dose sodium bicarbonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4020', 'city': 'Linz', 'state': 'Upper Austria', 'country': 'Austria', 'facility': 'Ordensklinikum Linz GmbH Elisabethinen', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}], 'overallOfficials': [{'name': 'Daniela Cejka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Nephrology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prim. Priv. Doz. Dr. Daniel Cejka', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medice Arzneimittel Pütter GmbH & Co KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Nephrology', 'investigatorFullName': 'Prim. Priv. Doz. Dr. Daniel Cejka', 'investigatorAffiliation': 'Elisabethinen Hospital'}}}}