FrailtyNCT07836127
Human Albumin Combined With Plasma Exchange for Frailty Intervention
A study testing Plasma Exchange, 5% human albumin and Intravenous immunoglobulin (IVIG) in people with Frailty and Plasma Exchange, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Background Frailty is an age-related syndrome characterized by reduced physiological reserve, decreased stress tolerance and multisystem functional decline in the elderly, which markedly increases the risks of falls, hospitalization, functional impairment and all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Plasma Exchange
- What is being tested?
- Plasma Exchange, 5% human albumin and Intravenous immunoglobulin (IVIG)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 24 Sep 2026to 14 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Clear consciousness and ability to communicate.
- Sufficient cognitive function and educational level to complete all study-related assessments.
- A score of ≥ 1 on the FRAIL scale.
- Voluntary written informed consent.
Who cannot join
- Known allergy or hypersensitivity to albumin (ALB) or intravenous immunoglobulin (IVIg).
- Currently receiving albumin (ALB) and/or intravenous immunoglobulin (IVIg) infusion for other reasons.
- Severe cardiac, hepatic, or renal insufficiency.
- Active infection or acute exacerbation of chronic infection.
- Current use of direct oral anticoagulants (DOACs).
- History of bleeding disorders or coagulation dysfunction.
Show all 10Show fewer
- Concomitant malignancy or expected survival of less than 6 months.
- Severe visual, auditory, or motor function impairment.
- Refusal to sign the informed consent form.
- Other conditions that, in the opinion of the investigator, make the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, Tianjin Municipality, 300041
02223608316, wangying@ihcams.ac.cn
About this study
Official title: A Prospective, Randomized Exploratory Study on the Intervention of Frailty With Human Albumin Combined With Plasma Exchange
Background Frailty is an age-related syndrome characterized by reduced physiological reserve, decreased stress tolerance and multisystem functional decline in the elderly, which markedly increases the risks of falls, hospitalization, functional impairment and all-cause mortality. Chronic low-grade inflammation, immune senescence, oxidative stress and abnormal protein modification are key mechanisms underlying the development and progression of frailty. Current mainstream interventions including nutritional support and physical exercise yield limited efficacy for moderate to severe frailty, and targeted therapies against biological aging mechanisms are still lacking.Objective To evaluate the efficacy and safety of plasma exchange combined with human albumin (ALB), with or without intravenous immunoglobulin (IVIg), in the treatment of frailty, and to preliminarily explore the potential mechanisms of the combined therapy.Methods This is a prospective, randomized, exploratory clinical trial. A total of 34 participants with a FRAIL scale score ≥ 1 will be enrolled and randomly assigned at a 1:1 ratio into two groups, with 17 cases in each group: the plasma exchange plus ALB group and the plasma exchange plus ALB plus IVIg group. The study consists of a screening phase, a 5-month treatment phase with six intervention sessions, and follow-up visits at 1, 3 and 6 months after the final treatment. Frailty status, physical function, laboratory parameters, inflammatory levels and albumin modification will be dynamically assessed throughout the trial, and adverse events will be recorded.Results The trial has not yet been initiated. It is expected that the within-group and between-group comparisons will clarify the therapeutic effects and long-term stability of the two regimens, as well as their safety profiles. Changes in biomarkers will help illustrate the potential molecular mechanisms of plasma purification combined with functional protein supplementation for frailty.Conclusion Plasma exchange combined with ALB (with or without IVIg) can exert multi-target intervention on frailty by eliminating aging-related toxic factors and restoring plasma and immune homeostasis. The findings of this study will provide preliminary clinical evidence and theoretical basis for novel biological therapeutic strategies for frailty.
Read the detailed description
Frailty is a common age-related clinical syndrome characterized by progressive decline in physiological reserve, reduced stress tolerance, and multisystem functional impairment in older adults. It significantly increases the risk of adverse outcomes including falls, hospitalizations, functional dependence, and all-cause mortality. Chronic low-grade inflammation, immune senescence, oxidative stress, and abnormal protein modification are considered key biological mechanisms driving the onset and progression of frailty. Current mainstream interventions, such as nutritional support and physical exercise, have shown only limited efficacy in moderate to severe frailty, and targeted biological therapies for frailty remain lacking. This study aims to evaluate the efficacy and safety of plasma exchange combined with human albumin (ALB), with or without adjunctive intravenous immunoglobulin (IVIg), in the treatment of frailty, and to preliminarily explore the potential mechanisms underlying the combined therapy.
This is a prospective, randomized, exploratory clinical trial. A total of 34 participants with a FRAIL scale score of ≥ 1 will be enrolled and randomly assigned at a 1:1 ratio into two groups (17 participants in each group): the plasma exchange plus human albumin group (ALB group) and the plasma exchange plus human albumin plus intravenous immunoglobulin group (ALB + IVIg group). The study is divided into three phases: a screening phase, a treatment phase, and a follow-up phase.
The screening phase will be conducted within 7 days prior to the first treatment. Eligible subjects will sign an informed consent form and complete a comprehensive baseline assessment, including frailty status evaluation, physical function testing, routine laboratory and imaging examinations, frailty-related biomarker detection, albumin (ALB) modification profiling, and inflammatory marker testing to confirm eligibility.
The treatment phase will last for 5 months, consisting of a total of 6 treatment sessions administered monthly. Systemic assessments will be performed at each visit, including frailty status evaluation, physical function testing, routine pre-treatment examinations, frailty-related biomarker detection, ALB modification profiling, and inflammatory marker testing, to monitor treatment response and safety. Blood samples for complete blood count and coagulation function will be collected within 1 hour after the first plasma exchange session. All participants will receive plasma exchange with 5% human albumin solution as the replacement fluid, according to the study protocol. Subjects in the ALB + IVIg group will additionally receive intravenous immunoglobulin (IVIg) immediately after each plasma exchange session. Adverse events will be recorded throughout the study.
Follow-up visits will be conducted at 1, 3, and 6 months after the final treatment session. All assessments and laboratory tests will be repeated to evaluate the long-term efficacy, safety, and sustained effects of the interventions.
This trial has not yet been initiated. It is expected that within-group and between-group comparisons will clarify the therapeutic effects and long-term stability of the two regimens, as well as their safety profiles. Changes in frailty-related biomarkers, inflammatory markers, and albumin modification patterns will help to illustrate the potential molecular mechanisms of plasma exchange combined with functional protein supplementation for frailty. It is hypothesized that plasma exchange combined with ALB (with or without IVIg) may exert multi-targeted intervention on frailty by eliminating aging-related toxic factors and restoring plasma and immune homeostasis. The findings of this study will provide preliminary clinical evidence and a theoretical basis for novel biological therapeutic strategies for frailty.
- Conditions
- Frailty, Plasma Exchange
- Being tested
- Plasma Exchange, 5% human albumin, Intravenous immunoglobulin (IVIG)
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma ExchangeProcedure or surgery
Plasma exchange procedure, target exchange volume 50±5 mL/kg per session, flow rate 40-60 mL/min, administered once monthly for 6 cycles.
5% human albuminBiological
Equal-volume 5% human albumin solution used as replacement fluid during plasma exchange.
Intravenous immunoglobulin (IVIG)Biological
IVIg administered at a fixed dose of 2.5 g per subject, infused immediately after each plasma exchange session.
| Study group | Role | What they receive |
|---|---|---|
| Plasma Exchange + Human Albumin Group | Experimental | All subjects receive standard background therapy. Subjects receive monthly plasma exchange for 6 cycles with 5% human albumin as replacement fluid, no IVIg administration. Receives: Procedure: Plasma Exchange; Biological: 5% human albumin |
| Experimental: Plasma Exchange + Human Albumin + IVIg Group | Experimental | All subjects receive standard background therapy. Subjects receive monthly plasma exchange for 6 cycles with 5% human albumin replacement fluid, plus IVIg 2.5 g after each exchange session. Receives: Procedure: Plasma Exchange; Biological: 5% human albumin; Biological: Intravenous immunoglobulin (IVIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy rate of frailty intervention at 1 month after the last treatment
Calculation formula: [(Baseline score - Follow-up score at 1 month after the last treatment) / Baseline score] × 100%. This rate represents the degree of improvement in patients' frailty status following intervention.
Measured: 1 month after the last treatment
Secondary outcomes (23)
Efficacy rate of frailty intervention assessed by FRAIL Scale
The efficacy rate of frailty intervention calculated based on the FRAIL Scale (Fatigue, Resistance, Ambulation, Illnesses, Loss of weight). The scale ranges from 0 (no frailty) to 5 (severe frailty); higher scores indicate worse frailty status. Efficacy rate = (Baseline score - Score at follow-up) / Baseline score × 100%.
Measured: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Strand specificity of frailty-related cfDNA and therapeutic response to plasma exchange
Assess strand specificity of frailty-related circulating cell-free DNA and evaluate its predictive value for plasma exchange treatment response.
Measured: Baseline, 1 month and 6 months after the last treatment
Clonal hematopoiesis gene mutation dynamics and correlation with frailty
Observe clonal hematopoiesis-associated gene mutation and clonal evolution at baseline, 1 month and 6 months post last treatment; explore the correlation between clonal hematopoiesis features and frailty status.
Measured: Baseline, 4 week,24 week, 28 week, and 32 week after enrollment
BCR clonotype characteristics
Analysis of BCR clonotype derived from identical BCR high-throughput sequencing assay. Assessments are performed at baseline, 1 month and 6 months after the last treatment.
Measured: Baseline, 1 month and 6 months after the last treatment
BCR V/J gene usage bias
Analysis of BCR V/J gene usage bias derived from identical BCR high-throughput sequencing assay. Assessments are performed at baseline, 1 month and 6 months after the last treatment.
Measured: Baseline, 1 month and 6 months after the last treatment
BCR diversity index
Analysis of BCR diversity index derived from identical BCR high-throughput sequencing assay. Assessments are performed at baseline, 1 month and 6 months after the last treatment.
Measured: Baseline, 1 month and 6 months after the last treatment
Frequency of senescence-associated antigen-specific B cell clones
Analysis of senescence-associated antigen-specific B cell clones derived from identical BCR high-throughput sequencing assay. Assessments are performed at baseline, 1 month and 6 months after the last treatment.
Measured: Baseline, 1 month and 6 months after the last treatment
TCR clonotype characteristics
Analysis of TCR clonotype derived from a single unified TCR high-throughput sequencing assay. Assessments are performed at baseline, 1 month and 6 months after the last treatment.
Measured: Baseline, 1 month and 6 months after the last treatment
TCR diversity index
Analysis of TCR diversity index derived from a single unified TCR high-throughput sequencing assay. Assessments are performed at baseline, 1 month and 6 months after the last treatment.
Measured: Baseline, 1 month and 6 months after the last treatment
TCR V/J gene usage bias
Analysis of TCR V/J gene usage bias derived from a single unified TCR high-throughput sequencing assay. Assessments are performed at baseline, 1 month and 6 months after the last treatment.
Measured: Baseline, 1 month and 6 months after the last treatment
Frequency of senescence-associated antigen-specific T cell clones
Analysis of senescence-associated antigen-specific T cell clones derived from a single unified TCR high-throughput sequencing assay. Assessments are performed at baseline, 1 month and 6 months after the last treatment.
Measured: Baseline, 1 month and 6 months after the last treatment
Between-group differences in frailty scale score: ALB group vs ALB+IVIg group
Compare the changes of frailty scale score between albumin monotherapy group and albumin combined with IVIg group.
Measured: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Baseline changes of serum ALB modification at 1 month after last treatment
Evaluate the alterations of serum albumin subtypes including oxidation, glycation, nitration, sulfenylation, cysteinylation, cysteinylation combined with glycation versus baseline.
Measured: 1 month after the last treatment
Changes from baseline in senescence-related indicators at 1 month after last treatment
Detect plasma proteome and glycoproteome related to senescence, including SASP, serum inflammatory factors and epigenetic senescence clock, and analyze their changes compared with baseline.
Measured: 1 month after the last treatment
Changes from baseline in Tilburg Frailty Indicator (TFI) scores
To evaluate the changes of Tilburg Frailty Indicator (TFI) score compared with baseline at each follow-up time point.
Measured: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Changes from baseline in Fried Frailty Phenotype Scale scores
To evaluate the change of Fried Frailty Phenotype Scale score compared with baseline.
This is one single outcome indicator (scale score) assessed repeatedly at multiple planned follow-up time points, not multiple distinct outcome measures.This represents one continuous outcome (Frailty Phenotype score) assessed longitudinally at multiple prespecified time points.
Measured: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Changes from baseline in physical and mental health questionnaire scores
Assess changes from baseline in EQ-5D, PROMIS-29, Generalized Anxiety Disorder (GAD) scale, Patient Health Questionnaire (PHQ), Pittsburgh Sleep Quality Index (PSQI).
Measured: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Short Physical Performance Battery (SPPB) score
To evaluate patients' physical function using the Short Physical Performance Battery (SPPB). This single continuous scale outcome will be repeatedly assessed at multiple scheduled follow-up time points.
Measured: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Changes in gene mutation frequency and its correlation with immune cell subsets
Analyze the shift of gene mutation frequency before and after treatment, and explore the correlation between mutation frequency and immune cell profiles.
Measured: Baseline, 1 month and 6 months after the last treatment
Changes from baseline in CRP
Detect serum CRP, and calculate their changes compared with baseline at predefined visits.
Measured: Baseline, 4 week, 24 week, 28 week, and 32 week after enrollment
Changes from baseline in ESR levels
Detect serum erythrocyte sedimentation rate (ESR) , and calculate their changes compared with baseline at predefined visits.
Measured: Baseline, 4 week, 24 week, 28 week, and 32 week after enrollment
Changes from baseline in ferritin levels
To assess changes in serum ferritin concentration relative to baseline.
Measured: Baseline, 4 week, 24 week, 28 week, and 32 week after enrollment
Incidence of adverse events during treatment
The incidence rate of all adverse events occurring during the treatment period will be calculated. Focused adverse events include catheter-related infections, hypersensitivity reactions, thrombosis, and other related adverse events.
Measured: From initiation of the first treatment through 6-month after completion of all study treatments, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start24 Sep 2026 (estimated)
- Primary completion14 May 2028 (estimated)
- Study completion14 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836127
- Sponsor's protocol ID
- IIT2026049
- Status last verified
- Sep 2026
- First submitted
- 8 Jun 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Exploratory Study on the Intervention of Frailty With Human Albumin Combined With Plasma Exchange
- ClinicalTrials.gov ID
- NCT07836127
- Acronym / sponsor ID
- IIT2026049
- Conditions
- Frailty, Plasma Exchange
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 24 Sep 2026 (estimated)
- Primary completion
- 14 May 2028 (estimated)
- Study completion
- 14 Nov 2028 (estimated)
- First posted
- 23 Sep 2026 (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.
Background Frailty is an age-related syndrome characterized by reduced physiological reserve, decreased stress tolerance and multisystem functional decline in the elderly, which markedly increases the risks of falls, hospitalization, functional impairment and all-cause mortality. Chronic low-grade inflammation, immune senescence, oxidative stress and abnormal protein modification are key mechanisms underlying the development and progression of frailty. Current mainstream interventions including nutritional support and physical exercise yield limited efficacy for moderate to severe frailty, and targeted therapies against biological aging mechanisms are still lacking.Objective To evaluate the efficacy and safety of plasma exchange combined with human albumin (ALB), with or without intravenous immunoglobulin (IVIg), in the treatment of frailty, and to preliminarily explore the potential mechanisms of the combined therapy.Methods This is a prospective, randomized, exploratory clinical trial. A total of 34 participants with a FRAIL scale score ≥ 1 will be enrolled and randomly assigned at a 1:1 ratio into two groups, with 17 cases in each group: the plasma exchange plus ALB group and the plasma exchange plus ALB plus IVIg group. The study consists of a screening phase, a 5-month treatment phase with six intervention sessions, and follow-up visits at 1, 3 and 6 months after the final treatment. Frailty status, physical function, laboratory parameters, inflammatory levels and albumin modification will be dynamically assessed throughout the trial, and adverse events will be recorded.Results The trial has not yet been initiated. It is expected that the within-group and between-group comparisons will clarify the therapeutic effects and long-term stability of the two regimens, as well as their safety profiles. Changes in biomarkers will help illustrate the potential molecular mechanisms of plasma purification combined with functional protein supplementation for frailty.Conclusion Plasma exchange combined with ALB (with or without IVIg) can exert multi-target intervention on frailty by eliminating aging-related toxic factors and restoring plasma and immune homeostasis. The findings of this study will provide preliminary clinical evidence and theoretical basis for novel biological therapeutic strategies for frailty.
Detailed description
Frailty is a common age-related clinical syndrome characterized by progressive decline in physiological reserve, reduced stress tolerance, and multisystem functional impairment in older adults. It significantly increases the risk of adverse outcomes including falls, hospitalizations, functional dependence, and all-cause mortality. Chronic low-grade inflammation, immune senescence, oxidative stress, and abnormal protein modification are considered key biological mechanisms driving the onset and progression of frailty. Current mainstream interventions, such as nutritional support and physical exercise, have shown only limited efficacy in moderate to severe frailty, and targeted biological therapies for frailty remain lacking. This study aims to evaluate the efficacy and safety of plasma exchange combined with human albumin (ALB), with or without adjunctive intravenous immunoglobulin (IVIg), in the treatment of frailty, and to preliminarily explore the potential mechanisms underlying the combined therapy.
This is a prospective, randomized, exploratory clinical trial. A total of 34 participants with a FRAIL scale score of ≥ 1 will be enrolled and randomly assigned at a 1:1 ratio into two groups (17 participants in each group): the plasma exchange plus human albumin group (ALB group) and the plasma exchange plus human albumin plus intravenous immunoglobulin group (ALB + IVIg group). The study is divided into three phases: a screening phase, a treatment phase, and a follow-up phase.
The screening phase will be conducted within 7 days prior to the first treatment. Eligible subjects will sign an informed consent form and complete a comprehensive baseline assessment, including frailty status evaluation, physical function testing, routine laboratory and imaging examinations, frailty-related biomarker detection, albumin (ALB) modification profiling, and inflammatory marker testing to confirm eligibility.
The treatment phase will last for 5 months, consisting of a total of 6 treatment sessions administered monthly. Systemic assessments will be performed at each visit, including frailty status evaluation, physical function testing, routine pre-treatment examinations, frailty-related biomarker detection, ALB modification profiling, and inflammatory marker testing, to monitor treatment response and safety. Blood samples for complete blood count and coagulation function will be collected within 1 hour after the first plasma exchange session. All participants will receive plasma exchange with 5% human albumin solution as the replacement fluid, according to the study protocol. Subjects in the ALB + IVIg group will additionally receive intravenous immunoglobulin (IVIg) immediately after each plasma exchange session. Adverse events will be recorded throughout the study.
Follow-up visits will be conducted at 1, 3, and 6 months after the final treatment session. All assessments and laboratory tests will be repeated to evaluate the long-term efficacy, safety, and sustained effects of the interventions.
This trial has not yet been initiated. It is expected that within-group and between-group comparisons will clarify the therapeutic effects and long-term stability of the two regimens, as well as their safety profiles. Changes in frailty-related biomarkers, inflammatory markers, and albumin modification patterns will help to illustrate the potential molecular mechanisms of plasma exchange combined with functional protein supplementation for frailty. It is hypothesized that plasma exchange combined with ALB (with or without IVIg) may exert multi-targeted intervention on frailty by eliminating aging-related toxic factors and restoring plasma and immune homeostasis. The findings of this study will provide preliminary clinical evidence and a theoretical basis for novel biological therapeutic strategies for frailty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasma Exchange + Human Albumin Group | Experimental | Procedure: Plasma Exchange, Biological: 5% human albuminAll subjects receive standard background therapy. Subjects receive monthly plasma exchange for 6 cycles with 5% human albumin as replacement fluid, no IVIg administration. |
| Experimental: Plasma Exchange + Human Albumin + IVIg Group | Experimental | Procedure: Plasma Exchange, Biological: 5% human albumin, Biological: Intravenous immunoglobulin (IVIG)All subjects receive standard background therapy. Subjects receive monthly plasma exchange for 6 cycles with 5% human albumin replacement fluid, plus IVIg 2.5 g after each exchange session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Clear consciousness and ability to communicate.
- Sufficient cognitive function and educational level to complete all study-related assessments.
- A score of ≥ 1 on the FRAIL scale.
- Voluntary written informed consent.
Key exclusion criteria (10 listed)
- Known allergy or hypersensitivity to albumin (ALB) or intravenous immunoglobulin (IVIg).
- Currently receiving albumin (ALB) and/or intravenous immunoglobulin (IVIg) infusion for other reasons.
- Severe cardiac, hepatic, or renal insufficiency.
- Active infection or acute exacerbation of chronic infection.
- Current use of direct oral anticoagulants (DOACs).
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 |
|---|---|---|
| Plasma ExchangePlasma exchange procedure, target exchange volume 50±5 mL/kg per session, flow rate 40-60 mL/min, administered once monthly for 6 cycles. | Procedure or surgery | Experimental: Plasma Exchange + Human Albumin + IVIg Group, Plasma Exchange + Human Albumin Group |
| 5% human albuminEqual-volume 5% human albumin solution used as replacement fluid during plasma exchange. | Biological | Experimental: Plasma Exchange + Human Albumin + IVIg Group, Plasma Exchange + Human Albumin Group |
| Intravenous immunoglobulin (IVIG)IVIg administered at a fixed dose of 2.5 g per subject, infused immediately after each plasma exchange session. | Biological | Experimental: Plasma Exchange + Human Albumin + IVIg Group |
Primary outcome
Efficacy rate of frailty intervention at 1 month after the last treatment
Time frame: 1 month after the last treatment
Calculation formula: [(Baseline score - Follow-up score at 1 month after the last treatment) / Baseline score] × 100%. This rate represents the degree of improvement in patients' frailty status following intervention.
23 secondary outcomes
Efficacy rate of frailty intervention assessed by FRAIL Scale
Time frame: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Strand specificity of frailty-related cfDNA and therapeutic response to plasma exchange
Time frame: Baseline, 1 month and 6 months after the last treatment
Clonal hematopoiesis gene mutation dynamics and correlation with frailty
Time frame: Baseline, 4 week,24 week, 28 week, and 32 week after enrollment
BCR clonotype characteristics
Time frame: Baseline, 1 month and 6 months after the last treatment
BCR V/J gene usage bias
Time frame: Baseline, 1 month and 6 months after the last treatment
BCR diversity index
Time frame: Baseline, 1 month and 6 months after the last treatment
Frequency of senescence-associated antigen-specific B cell clones
Time frame: Baseline, 1 month and 6 months after the last treatment
TCR clonotype characteristics
Time frame: Baseline, 1 month and 6 months after the last treatment
TCR diversity index
Time frame: Baseline, 1 month and 6 months after the last treatment
TCR V/J gene usage bias
Time frame: Baseline, 1 month and 6 months after the last treatment
Frequency of senescence-associated antigen-specific T cell clones
Time frame: Baseline, 1 month and 6 months after the last treatment
Between-group differences in frailty scale score: ALB group vs ALB+IVIg group
Time frame: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Baseline changes of serum ALB modification at 1 month after last treatment
Time frame: 1 month after the last treatment
Changes from baseline in senescence-related indicators at 1 month after last treatment
Time frame: 1 month after the last treatment
Changes from baseline in Tilburg Frailty Indicator (TFI) scores
Time frame: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Changes from baseline in Fried Frailty Phenotype Scale scores
Time frame: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Changes from baseline in physical and mental health questionnaire scores
Time frame: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Short Physical Performance Battery (SPPB) score
Time frame: Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment
Changes in gene mutation frequency and its correlation with immune cell subsets
Time frame: Baseline, 1 month and 6 months after the last treatment
Changes from baseline in CRP
Time frame: Baseline, 4 week, 24 week, 28 week, and 32 week after enrollment
Changes from baseline in ESR levels
Time frame: Baseline, 4 week, 24 week, 28 week, and 32 week after enrollment
Changes from baseline in ferritin levels
Time frame: Baseline, 4 week, 24 week, 28 week, and 32 week after enrollment
Incidence of adverse events during treatment
Time frame: From initiation of the first treatment through 6-month after completion of all study treatments, assessed up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma Exchange, 5% human albumin and Intravenous immunoglobulin (IVIG) in people with Frailty and Plasma Exchange, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 23 Sep 2026. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Wang (022-23608316, wangying@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy rate of frailty intervention at 1 month after the last treatment (time frame: 1 month after the last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.