AgingPhase 3NCT06534450
The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
A Phase 3 study testing Therapeutic Plasma Exchange and IVIG in people with Aging, run by Dobri Kiprov at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Therapeutic Plasma Exchange and IVIG
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to Aug 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects over 50 years of age with or without chronic inflammatory condition
Who cannot join
- Poor peripheral vascular access
- Diagnosis of active malignancy
- 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.
- Presence of active infection
- Alcohol or drug dependency
- Psychiatric disorder that will interfere with participation in the study (e.g., schizophrenia, bipolar disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Randomized Placebo (Sham Pheresis) Controlled Clinical Trial To Evaluate The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
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.
- Conditions
- Aging
- Being tested
- Sham, Therapeutic Plasma Exchange, IVIG
- Keywords
- Therapeutic Plasma Exchange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShamDevice
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.
Therapeutic Plasma ExchangeDevice
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.
IVIGDrug
Intravenous Immunoglobulin
| Study group | Role | What they receive |
|---|---|---|
| TPE Monthly | Active comparator | will receive 6 monthly TPE procedures (TOTAL 6 treatments) Receives: Device: Therapeutic Plasma Exchange |
| TPE Bimonthly | Active comparator | 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) Receives: Device: Therapeutic Plasma Exchange |
| TPE Bimonthly with IVIG | Active comparator | 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) Receives: Device: Therapeutic Plasma Exchange; Drug: IVIG |
| Sham | Sham comparator | Sham TPE PROCEDURE once a month for 6 months (total of 6 treatments) Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and unanticipated events total for TPE safety
The primary objective is to assure the safety of long term TPE
Measured: through study completion, an average of 1 year
Rate of change to blood epigenetic clock from TPE
The objective is to compare the rate of change to the blood epigenetic clock from TPE.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Change in hand grip strength
The objective is to compare changes in hand grip strength from TPE
Measured: after study completion, an average of 2 years
Change in time up and go test
The objective is to compare changes in the time up and go test from TPE
Measured: after study completion, an average of 2 years
Change in balance time
The objective is to compare changes in balance time from TPE
Measured: after study completion, an average of 2 years
Change in short-form health survey score
The objective is to compare changes in short-form health survey scores from TPE, with higher scores being better
Measured: after study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start12 Sep 2022
- Primary completion30 Nov 2023
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dobri Kiprov
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIRCULATE, Inc.
- Responsible party
- Sponsor-investigator, Dobri Kiprov, Global Apheresis, Inc.
- Investigators
- Dobri Kiprov, MD, Principal investigator, Global Apheresis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534450
- Sponsor's protocol ID
- 7348
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 40424097
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Randomized Placebo (Sham Pheresis) Controlled Clinical Trial To Evaluate The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics
- ClinicalTrials.gov ID
- NCT06534450
- Acronym / sponsor ID
- 7348
- Conditions
- Aging
- Keywords
- Therapeutic Plasma Exchange
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dobri KiprovIndustry (pharma, biotech, devices)
- Collaborators
- CIRCULATE, Inc.
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TPE Monthly | Active comparator | Device: Therapeutic Plasma Exchangewill receive 6 monthly TPE procedures (TOTAL 6 treatments) |
| TPE Bimonthly | Active comparator | Device: Therapeutic Plasma Exchangewill 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) |
| TPE Bimonthly with IVIG | Active comparator | Device: Therapeutic Plasma Exchange, Drug: IVIGwill 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) |
| Sham | Sham comparator | Device: ShamSham TPE PROCEDURE once a month for 6 months (total of 6 treatments) |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects over 50 years of age with or without chronic inflammatory condition
Key exclusion criteria (6 listed)
- Poor peripheral vascular access
- Diagnosis of active malignancy
- 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.
- Presence of active infection
- Alcohol or drug dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShamThe 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. | Device | Sham |
| Therapeutic Plasma ExchangeBlood 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. | Device | TPE Bimonthly, TPE Bimonthly with IVIG, TPE Monthly |
| IVIGIntravenous Immunoglobulin | Drug | TPE Bimonthly with IVIG |
Primary outcome
Adverse events and unanticipated events total for TPE safety
Time frame: through study completion, an average of 1 year
The primary objective is to assure the safety of long term TPE
Rate of change to blood epigenetic clock from TPE
Time frame: through study completion, an average of 1 year
The objective is to compare the rate of change to the blood epigenetic clock from TPE.
4 secondary outcomes
Change in hand grip strength
Time frame: after study completion, an average of 2 years
Change in time up and go test
Time frame: after study completion, an average of 2 years
Change in balance time
Time frame: after study completion, an average of 2 years
Change in short-form health survey score
Time frame: after study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Derived from this study: PubMed 40424097Fuentealba 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dobri Kiprov, MD principal investigator
Global Apheresis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Therapeutic Plasma Exchange and IVIG in people with Aging, run by Dobri Kiprov at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and unanticipated events total for TPE safety (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06534450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.