drugset / Trial / NCT06534450

The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics

NCT06534450

Phase 3 Active not recruiting 40 enrolled Dobri Kiprov CIRCULATE, Inc. · collab
RandomizedParallel-groupSingle-blindOther

Summary

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.

Timeline

Start
2022-09-12
Primary completion
2023-11-30
Completion
2025-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Immune Globulin Intravenous (Human) Protein / enzyme biologic 2 g Intravenous

Indications

No indication recorded.