Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-10 @ 2:47 PM
Study NCT ID:
NCT03270956
Status:
COMPLETED
Last Update Posted:
2025-03-24
First Post:
2017-08-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@prokidney.com', 'phone': 'n/a', 'title': 'to be determined', 'organization': 'ProKidney'}, 'certainAgreement': {'otherDetails': '60-day review period can be extended an additional 30 days if Sponsor determines publication describes potentially patentable inventions. Publication not to be delayed more than 90 days after receipt of the proposed publication.\n\nSponsor may not require changes to the communication except to request removal of Sponsor Confidential Information.\n\nNo publication or disclosure shall be made by PI until the earlier of publication coordinated by Sponsor or 18 months after Study completion', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'the day of biopsy through 24 months after the final injection of REACT, approximately 33 months', 'description': "All AEs that occur from the biopsy procedure, during treatment, or within 24 months following the final REACT injection, whether or not they are related to study procedures or the investigational product, must be recorded in the subject's medical records as well as the CRF provided by the Sponsor or its designee.", 'eventGroups': [{'id': 'EG000', 'title': 'Renal Autologous Cell Therapy (REACT)', 'description': 'Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.\n\nRenal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 2, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'ESRD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'renal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'ESRD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Subcapsular renal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Procedure and/or Product Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Autologous Cell Therapy (REACT)', 'description': 'Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.\n\nRenal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)'}], 'classes': [{'title': 'All Body Systems', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000'}]}]}, {'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000'}]}]}, {'title': 'renal haematoma', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}, {'title': 'subcapsular renal hematoma', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'haematuria', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'perinephric collection', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Blood and lymphatic system disorder', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'anaemia', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'General disorders and administration site conditions', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'fatigue', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Injury, poisoning, and procedural complications', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'procedural pain', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 24 months following last REACT injection', 'description': 'Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Renal Specific Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Autologous Cell Therapy (REACT)', 'description': 'Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.\n\nRenal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)'}], 'classes': [{'title': 'Renal and urinary disorders', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000'}]}]}, {'title': 'End Stage Renal Disease', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Renal haematoma', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Acute Kidney Disease', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Kidney Disease', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Subcapsular renal haematoma', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}]}]}, {'title': 'Haematuria', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'Hydronephrosis', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}, {'title': 'perinephric collection', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 24 months following last REACT injection', 'description': 'Percentage of subjects with renal-specific adverse events by System Order Class and Preferred Term', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Renal Autologous Cell Therapy (REACT)', 'description': 'Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.\n\nRenal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Renal Autologous Cell Therapy (REACT)', 'description': 'Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.\n\nRenal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'spread': '5.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI (kg/m^2) at Screening,', 'classes': [{'categories': [{'measurements': [{'value': '35.20', 'spread': '8.415', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Volume (cm^3) - Treated kidney', 'classes': [{'categories': [{'measurements': [{'value': '180.97', 'spread': '76.077', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^3', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Volume (cm^3) - Untreated kidney', 'classes': [{'categories': [{'measurements': [{'value': '163.93', 'spread': '35.279', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm^3', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-12', 'size': 6353847, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-12T15:55', 'hasProtocol': True}, {'date': '2022-11-04', 'size': 1483050, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-12T15:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2017-08-25', 'resultsFirstSubmitDate': '2025-02-12', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-05', 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure and/or Product Related Adverse Events', 'timeFrame': 'Through 24 months following last REACT injection', 'description': 'Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term'}], 'secondaryOutcomes': [{'measure': 'Renal Specific Adverse Events', 'timeFrame': 'Through 24 months following last REACT injection', 'description': 'Percentage of subjects with renal-specific adverse events by System Order Class and Preferred Term'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).', 'detailedDescription': "All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject is male or female, 30 to 65 years of age on the date of informed consent.\n2. The subject has an established diagnosis of T2DM.\n3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.\n4. The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection.\n5. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure.\n6. A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.\n\nExclusion Criteria:\n\n1. The subject has a history of type 1 diabetes mellitus.\n2. The subject has a history of renal transplantation.\n3. The subject has a serum HbA1c level greater than 10% at the Screening Visit.\n4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).\n5. The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.'}, 'identificationModule': {'nctId': 'NCT03270956', 'briefTitle': 'A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Prokidney'}, 'officialTitle': 'A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)', 'orgStudyIdInfo': {'id': 'REGEN-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal Autologous Cell Therapy (REACT)', 'description': 'Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.', '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': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona [WITHDRAWN]', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '83642', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Boise Kidney & Hypertension Institute', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina- Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University [WITHDRAWN]', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Ashley Johns', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Prokidney'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prokidney', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CTI Clinical Trial and Consulting Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}