Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-04-23 @ 7:43 PM
Study NCT ID:
NCT02558595
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2015-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'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': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D000072661', 'term': 'Ciliopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009536', 'term': 'Niacinamide'}], 'ancestors': [{'id': 'D009539', 'term': 'Nicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2015-09-21', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in acetylated/total p53 ratio measured by ELISA in peripheral blood mononuclear cells (PBMC)', 'timeFrame': 'Change from Baseline to Month 12', 'description': 'Sirtuin 1 deacetylates p53 protein, and niacinamide inhibits sirtuin 1. So an increase in acetylated/total p53 ratio in PBMC will be used as a marker of biological efficacy.'}], 'secondaryOutcomes': [{'measure': 'Change in height-adjusted total kidney volume', 'timeFrame': 'Change from Baseline to Month 12', 'description': 'Measured by MRI'}, {'measure': 'Change in score on pain questionnaire', 'timeFrame': 'Change from Baseline to Month 12', 'description': 'PKD-9 Pain Questionnaire: Range of scores from 13 (no pain or symptoms) to 70 (very severe symptoms almost every day)'}, {'measure': 'Change in urinary concentration of MCP-1', 'timeFrame': 'Change from Baseline to Month 12'}, {'measure': 'Change in estimated GFR', 'timeFrame': 'Change from Baseline to Month 12', 'description': 'Determined from serum creatinine concentrations using CKD-Epi equation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PKD', 'Kidney disease', 'Vitamin B3'], 'conditions': ['Polycystic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '39356039', 'type': 'DERIVED', 'citation': 'St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the effects of niacinamide on markers of kidney injury, inflammation, kidney cyst growth and kidney function.', 'detailedDescription': 'Polycystic Kidney Disease (PKD) is a genetic disease that affects about 1 in 500 people worldwide. It can lead to kidney failure which can lead to death. PKD causes the development of kidney cysts (fluid-filled balloons), which cause worsening kidney function. It is common for people with PKD to also have blood in the urine, kidney pain, high blood pressure, kidney stones, kidney infections, and cysts in the brain or other parts of the body.\n\nThere is currently no treatment known to stop cyst growth or a cure for the disease.\n\nParticipants in this study will be randomly assigned to one of two groups: niacinamide or placebo. Participants have an equal chance of being assigned to either of the groups. For people that qualify and decide to participate in this study, they will be asked to make five visits to the study clinic and complete two study related phone calls over the course of 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of autosomal dominant polycystic kidney disease (ADPKD).\n* Estimated glomerular filtration rate (eGFR) \\> 50 ml/min/1.73m2 as determined from the serum creatinine by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n* Provide Informed consent\n\nExclusion Criteria:\n\n* History of liver disease or abnormal liver function test\n* Heavy alcohol intake\n* Chronic diarrhea or malabsorption syndrome\n* Thrombocytopenia\n* Hypophosphatemia\n* Pregnancy or lactation or plan to become pregnant during the study\n* Treatment with anti-epileptic drugs\n* Treatment with tolvaptan, current or within 2 months prior to screening\n* Participation in another interventional trial currently or within 2 months prior to screening.\n\nExclusions specific to magnetic resonance (MR) imaging acquisition and measurement:\n\n* Partial or total nephrectomy or renal cyst reduction (including aspiration) done \\<1 year ago\n* Cardiac pacemaker.\n* Presence of MR incompatible metallic clips (e.g. clipped cerebral aneurysm)\n* Body weight \\>159 kg (350 lbs) or untreatable claustrophobia.'}, 'identificationModule': {'nctId': 'NCT02558595', 'briefTitle': 'Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease', 'orgStudyIdInfo': {'id': 'STUDY00002827'}, 'secondaryIdInfos': [{'id': 'R21DK104086', 'link': 'https://reporter.nih.gov/quickSearch/R21DK104086', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Niacinamide', 'description': 'Participants will be asked to take niacinamide at a dose of 30 mg/kg/d orally.', 'interventionNames': ['Dietary Supplement: Niacinamide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be asked to take a placebo pill at a dose of 30 mg/kg/d orally.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Niacinamide', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nicotinamide', 'Vitamin B3'], 'armGroupLabels': ['Niacinamide']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo pill that matches niacinamide pill is size, shape and color', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Alan Yu, M.B., B.Chir', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Alan Yu, MB, BChir', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}