Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-29 @ 6:52 AM
Study NCT ID:
NCT06534450
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-02
First Post:
2024-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010951', 'term': 'Plasma Exchange'}, {'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D001803', 'term': 'Blood Transfusion'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010956', 'term': 'Plasmapheresis'}, {'id': 'D001781', 'term': 'Blood Component Removal'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-30', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events and unanticipated events total for TPE safety', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The primary objective is to assure the safety of long term TPE'}, {'measure': 'Rate of change to blood epigenetic clock from TPE', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The objective is to compare the rate of change to the blood epigenetic clock from TPE.'}], 'secondaryOutcomes': [{'measure': 'Change in hand grip strength', 'timeFrame': 'after study completion, an average of 2 years', 'description': 'The objective is to compare changes in hand grip strength from TPE'}, {'measure': 'Change in time up and go test', 'timeFrame': 'after study completion, an average of 2 years', 'description': 'The objective is to compare changes in the time up and go test from TPE'}, {'measure': 'Change in balance time', 'timeFrame': 'after study completion, an average of 2 years', 'description': 'The objective is to compare changes in balance time from TPE'}, {'measure': 'Change in short-form health survey score', 'timeFrame': 'after study completion, an average of 2 years', 'description': 'The objective is to compare changes in short-form health survey scores from TPE, with higher scores being better'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Therapeutic Plasma Exchange'], 'conditions': ['Aging']}, 'referencesModule': {'references': [{'pmid': '40424097', 'type': 'DERIVED', 'citation': 'Fuentealba M, Kiprov D, Schneider K, Mu WC, Kumaar PA, Kasler H, Burton JB, Watson M, Halaweh H, King CD, Yuksel ZS, Roska-Pamaong C, Schilling B, Verdin E, Furman D. Multi-Omics Analysis Reveals Biomarkers That Contribute to Biological Age Rejuvenation in Response to Single-Blinded Randomized Placebo-Controlled Therapeutic Plasma Exchange. Aging Cell. 2025 Aug;24(8):e70103. doi: 10.1111/acel.70103. Epub 2025 May 27.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assure the safety of long term therapeutic plasma exchange (TPE) with and without Intravenous Immunoglobulin (IVIG) and its effects on biomarkers and epigenetic biologic clocks in forty individuals. The main question is to assure the safety from long term TPE using changes in clinical and laboratory outcomes and also evaluating changes on additional blood biomarkers and epigenetic clocks during and after TPE treatment. Researchers will compare the TPE treatment group to the Sham treatment group to identify changes due to TPE. Participants will receive six TPE or Sham treatments over one of two treatment schedules and may receive IVIG with treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects over 50 years of age with or without chronic inflammatory condition\n\nExclusion Criteria:\n\n* Poor peripheral vascular access\n* Diagnosis of active malignancy\n* Late-stage Alzheimer's disease Any medical condition which may deteriorate because of plasma exchange procedures. These include, but are not limited to, symptomatic coronary artery disease, congestive heart failure and restrictive pulmonary disease (COPD). The investigators reserve the right to exclude anyone they feel may be harmed in any way by participating in the trial.\n* Presence of active infection\n* Alcohol or drug dependency\n* Psychiatric disorder that will interfere with participation in the study (e.g., schizophrenia, bipolar disorder)"}, 'identificationModule': {'nctId': 'NCT06534450', 'briefTitle': 'The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Global Apheresis, Inc.'}, 'officialTitle': 'A Comparative Randomized Placebo (Sham Pheresis) Controlled Clinical Trial To Evaluate The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics', 'orgStudyIdInfo': {'id': '7348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TPE Monthly', 'description': 'will receive 6 monthly TPE procedures (TOTAL 6 treatments)', 'interventionNames': ['Device: Therapeutic Plasma Exchange']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TPE Bimonthly', 'description': 'will receive 2 TPE procedures in one week. The same treatment will be repeated on a monthly basis two more times (Two treatments per month for three months to total 6 treatments)', 'interventionNames': ['Device: Therapeutic Plasma Exchange']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TPE Bimonthly with IVIG', 'description': 'will receive 2 TPE procedures followed by 2 gm of IVIG in one week. The same treatment will be repeated on a monthly basis twice more. (Two TPE procedures per month for three months - total of 6 treatments)', 'interventionNames': ['Device: Therapeutic Plasma Exchange', 'Drug: IVIG']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Sham TPE PROCEDURE once a month for 6 months (total of 6 treatments)', 'interventionNames': ['Device: Sham']}], 'interventions': [{'name': 'Sham', 'type': 'DEVICE', 'description': "The patient's blood will not circulate through the apheresis machine. The patient will receive approximately 250 cc of normal saline during each sham pheresis procedure.", 'armGroupLabels': ['Sham']}, {'name': 'Therapeutic Plasma Exchange', 'type': 'DEVICE', 'description': 'Blood is withdrawn from a peripheral or central vein into the blood cell separator which separates the whole blood into plasma and cell components. The plasma is removed and the blood cells are returned to the patient along with replacement fluids, most commonly 5% human albumin in normal saline.', 'armGroupLabels': ['TPE Bimonthly', 'TPE Bimonthly with IVIG', 'TPE Monthly']}, {'name': 'IVIG', 'type': 'DRUG', 'description': 'Intravenous Immunoglobulin', 'armGroupLabels': ['TPE Bimonthly with IVIG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94941', 'city': 'Mill Valley', 'state': 'California', 'country': 'United States', 'facility': 'Global Apheresis', 'geoPoint': {'lat': 37.90604, 'lon': -122.54498}}], 'overallOfficials': [{'name': 'Dobri Kiprov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Global Apheresis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dobri Kiprov', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CIRCULATE, Inc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief Medical Officer', 'investigatorFullName': 'Dobri Kiprov', 'investigatorAffiliation': 'Global Apheresis, Inc.'}}}}