Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:41 AM
Study NCT ID:
NCT06786260
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-29
First Post:
2025-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Di-PKD: A Pilot Trial of Dietary Intervention in Patients With Autosomal Dominant Polycystic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016891', 'term': 'Polycystic Kidney, Autosomal Dominant'}], 'ancestors': [{'id': 'D007690', 'term': 'Polycystic Kidney Diseases'}, {'id': 'D052177', 'term': 'Kidney Diseases, Cystic'}, {'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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2025-01-15', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of kidney cysts by change in total kidney volume (TKV) from baseline to 12 months', 'timeFrame': 'Change between baseline and 12 months', 'description': 'A composite measurement of MRI to determine total kidney volume (TKV) by kidney length, width, and depth will be done at baseline and again at 12 months. MRI results will be compared between the two-time points to assess the cyst progression, if any. An increase of about 5% per year from baseline will be significant.'}], 'secondaryOutcomes': [{'measure': 'Progression of kidney cysts as evidenced by urinary biomarkers from baseline to 12 months', 'timeFrame': 'Change between baseline and 12 months', 'description': 'A urine sample will be collected at the end of the preconditioning week to establish a baseline for the urinary biomarkers cAMP and MCP-1. This is a composite measurement. Values for cAMP and MCP-1 at 12 months will be compared to the baseline values. If the values at 12 months remain the same or less than the composite baseline values, this will indicate a low likelihood that the kidney cysts have progressed. A significant change of 20% or greater overall in the combined biomarkers will indicate a kidney cyst progression.'}, {'measure': 'Progression of kidney cysts as evidenced by serum biomarkers from baseline to 12 months', 'timeFrame': 'Change between baseline and 12 months', 'description': 'A blood draw will be performed at the end of the preconditioning week to establish a baseline for the serum biomarkers uric acid, ADH, FGF-23, bicarbonate, and cystatin C. This is a composite measurement. Values for uric acid, ADH, FGF-23, bicarbonate, and cystatin C at 12 months will be compared to the baseline values. If the values at 12 months remain the same or less than the composite baseline values, this will indicate a low likelihood that the kidney cysts have progressed. A significant change of 20% or greater overall in the combined biomarkers will indicate a kidney cyst progression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADPKD', 'Diet'], 'conditions': ['Autosomal Dominant Polycystic Kidney Disease (ADPKD)']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to evaluate the impact of a specific diet (low salt, limited caffeine, high potassium, low phosphate, limited protein, limited carbohydrate intake, adequate water intake) on changes in serum and urinary biomarkers, total kidney volume (TKV), and cyst progression in subjects with autosomal dominant polycystic kidney disease (ADPKD).\n\nResearchers will compare the results of subjects in the study diet (interventional) arm to the results of subjects in the regular diet (control) arm.', 'detailedDescription': '15 subjects will be enrolled in each dietary arm for a total of 30 subjects. All subjects will follow the study diet for one week, after which serum and urinary biomarkers will be measured. A baseline evaluation, including genetic testing, MRI, Mayo Clinic Imaging Classification and 10-question survey will also be conducted. After Week 1 of the study, subjects will be assigned to the intervention or control arm. Subjects will have six follow-up visits at months 1, 2, 3, 6, 9 and 12 to assess adherence to diet. Serum and urinary biomarkers will be repeated at each visit. MRI will be repeated at Month 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of ADPKD\n* Genetic testing confirmation of PKD1 or PKD2\n* eGFR \\>30mL/1.73m2\n* Willingness to adhere to a preconditioning diet for 1 week and ability to complete the study\n* Mayo Clinic Imaging Classification (MCIC): 1C, 1D, 1E\n\nExclusion Criteria:\n\n* History of dietary non-adherence\n* Subjects on Tolvaptan\n* Comorbidities that could interfere with participation (Diabetes, Heart Failure (EF\\<30%) Advanced Chronic Kidney Disease (CKD) Stage 4 and higher)'}, 'identificationModule': {'nctId': 'NCT06786260', 'acronym': 'ADPKD', 'briefTitle': 'Di-PKD: A Pilot Trial of Dietary Intervention in Patients With Autosomal Dominant Polycystic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Di-PKD: A Pilot Trial of a 12-Month Targeted Dietary Intervention on Cyst Progression in Patients With Autosomal Dominant Polycystic Kidney Disease', 'orgStudyIdInfo': {'id': '5240615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional Diet', 'description': 'Subjects will follow a specified diet (low salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake) after 1 week of preconditioning for 12 months.', 'interventionNames': ['Other: Interventional Diet']}, {'type': 'NO_INTERVENTION', 'label': 'Regular Diet', 'description': 'Subjects will follow the diet they normally adhere to after 1 week of preconditioning.'}], 'interventions': [{'name': 'Interventional Diet', 'type': 'OTHER', 'description': 'Low salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake diet', 'armGroupLabels': ['Interventional Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Amir Abdipour, MD', 'role': 'CONTACT', 'phone': '909-202-0252'}], 'facility': 'Loma Linda University Health', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'centralContacts': [{'name': 'Niloufar Ebrahimi Ebrahimi, MD', 'role': 'CONTACT', 'email': 'Nebrahimi@llu.edu', 'phone': '909-558-4000', 'phoneExt': '55885'}, {'name': 'Sayna Norouzi, MD', 'role': 'CONTACT', 'email': 'Snorouzi@llu.edu', 'phone': '909-558-4000'}], 'overallOfficials': [{'name': 'Amir Abdipour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}