Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-28 @ 9:34 PM
Study NCT ID:
NCT05694169
Status:
TERMINATED
Last Update Posted:
2025-02-28
First Post:
2022-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Participants With Chronic Kidney Disease Previously Treated With REACT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'C566906', 'term': 'Cakut'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'business decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2022-12-27', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoints is as follows:', 'timeFrame': 'through 12 months after last supplemental injection', 'description': 'Procedure and investigational product-related treatment-emergent adverse events (TEAE) will be assessed via:\n\n1. Biopsy Related SAEs\n2. Injection Procedure Related SAEs\n3. Investigational Product Related SAEs\n4. Treatment-Emergent SAEs.'}], 'secondaryOutcomes': [{'measure': 'First Secondary Endpoint', 'timeFrame': '12 months after the last supplemental injection', 'description': 'Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD)'}, {'measure': 'Second Secondary Endpoint', 'timeFrame': '12 months after the last supplemental injection', 'description': 'Percent of participants who have the same or reduced 2-year risk of ESRD'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['REACT', 'CAKUT', 'DKD'], 'conditions': ['Diabetic Kidney Disease', 'CAKUT', 'Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.', 'detailedDescription': 'A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.\n2. The participant is male or female, 30 to 80 years of age on the date of informed consent.\n3. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.\n4. The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.\n\nExclusion Criteria:\n\n1. The participant has a history of renal transplantation.\n2. The participant has received dialysis for more than 30 days.\n3. The participant has received any other investigational products after completion of REACT injections within 3 months of screening.\n4. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.\n5. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.'}, 'identificationModule': {'nctId': 'NCT05694169', 'briefTitle': 'A Study of Participants With Chronic Kidney Disease Previously Treated With REACT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prokidney'}, 'officialTitle': 'A Phase 1, Open-label, Supplemental Dosing Study of Participants With Chronic Kidney Disease Previously Treated With REACT (REGEN-015)', 'orgStudyIdInfo': {'id': 'REGEN-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal Autologous Cell Therapy (REACT)', 'description': 'Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.', 'interventionNames': ['Biological: Renal Autologous Cell Therapy (REACT)']}], 'interventions': [{'name': 'Renal Autologous Cell Therapy (REACT)', 'type': 'BIOLOGICAL', 'description': 'Autologous selected renal cells (SRC)', 'armGroupLabels': ['Renal Autologous Cell Therapy (REACT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83642', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Boise kidney and Hypertension Institute', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Prokidney'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prokidney', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}