Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-02 @ 9:08 AM
Study NCT ID:
NCT04020757
Status:
TERMINATED
Last Update Posted:
2020-03-12
First Post:
2019-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
H+ Mobilization With Dialysate Bicarbonate Variation
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Biochemical measurement techniques were deemed insufficient to continue research', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lactate levels', 'timeFrame': 'through study completion, a period of 3 weeks', 'description': '7 tests conducted through the dialysis treatment after the long interdialytic interval'}, {'measure': 'H+ mobilization', 'timeFrame': 'through study completion, a period of 3 weeks', 'description': '7 tests conducted through the dialysis treatment after the long interdialytic interval'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The aims of the proposed studies are first to delineate the physiological response of End Stage Kidney Disease (ESKD) patients to exposure to a bath \\[HCO3-\\] of 35 mEq/L and an \\[acetate\\] of 4 mEq/L, and second, to determine whether reducing bath \\[HCO3-\\] will have the expected effect of decreasing or abolishing stimulation of organic acid production. A secondary endpoint will be whether the patients tolerate such a reduction and its impact on pre-dialysis blood \\[HCO3-\\]. If the outcome is positive in both regards, future studies will measure well-being and outcomes with reduced bath \\[HCO3-\\].'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be 18 years or older,\n2. Have been on dialysis for at least 1 year,\n3. Be stable on treatment (i.e., without frequent changes in their dialysis prescription, or recent hospitalizations),\n4. Be reasonably nourished (serum albumin \\> 3.5 g/dl and not currently receiving oral nutritional supplement through DCI).\n5. Self-reported urine output of \\<200 cc/day\n6. Functioning arteriovenous fistulas or grafts for dialysis access\n7. Currently dialyzing at a dialysate \\[HCO3-\\] of 33-37 mEq/L.\n\nExclusion Criteria:\n\n1. Pregnancy,\n2. Acute illnesses of any kind,\n3. Hospitalization in the prior 3 months (except for vascular access related),\n4. Significant congestive heart failure, liver or lung failure.\n5. Pre-dialysis blood \\[HCO3-\\] \\<19 mEq/L) (to reduce the risk of metabolic acidosis )'}, 'identificationModule': {'nctId': 'NCT04020757', 'briefTitle': 'H+ Mobilization With Dialysate Bicarbonate Variation', 'organization': {'class': 'OTHER', 'fullName': 'Tufts Medical Center'}, 'officialTitle': 'H+ Mobilization With Dialysate Bicarbonate Variation', 'orgStudyIdInfo': {'id': '13296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bicarb Variation', 'description': 'Variation in dialysis bicarbonate, lowered to 30 mEq/L for week 2 of 3', 'interventionNames': ['Device: variation in dialysis bicarbonate', 'Dietary Supplement: Zone Perfect bar']}], 'interventions': [{'name': 'variation in dialysis bicarbonate', 'type': 'DEVICE', 'description': '35 mEq/L dialysate bicarbonate for one week, followed by 30 mEq/L for one week, followed by 35mEq/L for one week with nutritional supplement during dialysis', 'armGroupLabels': ['Bicarb Variation']}, {'name': 'Zone Perfect bar', 'type': 'DIETARY_SUPPLEMENT', 'description': '16g protein supplement given during first 30 mins of dialysis on last testing day', 'armGroupLabels': ['Bicarb Variation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tufts Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dialysis Clinic, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}