End Stage Renal DiseaseAEMD-IDE-20NCT02215902
Safety Study of the Aethlon Hemopurifier
A study testing Affinity plasmapheresis in people with End Stage Renal Disease and Hepatitis C Infection, run by Aethlon Medical Inc. at 1 site in United States.
Trial summary
Primary Objectives: To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood purification. Secondary Objectives: To quantify the number of viral copies captured by the Aethlon Hemopurifier® during the first and last Hemopurifier treatments using elution methods developed by Aethlon… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Hepatitis C Infection
- What is being tested?
- Affinity plasmapheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 10 Mar 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18 years of age and older.
- Positive test for HCV infection (any genotype).
- End-stage-renal disease (ESRD) requiring dialysis - already established on HD.
- The arteriovenous fistula, graft or central venous catheter must have been functioning adequately for at least 1 month before entry into study showing no signs of infection or blockage.
- Have recovered from the toxicity of any prior systemic therapy.
- Ability to tolerate blood volume losses of up to 150 ml per week, i.e. 50 ml each.
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- Stable clinical condition, including stable hemoglobin which has not fluctuated more than 1.5 -2.0 gm/dl within 28 days prior to enrollment into study.
- Must have the following minimum hematologic, biochemical, and serologic criteria documented within 28 days prior to enrollment into study:
- Hemoglobin values of ≥ 9.5 gm/dL for males and females
- Platelet count > 100,000/mm3
- Bilirubin < 4 mg/dL
- Albumin stable and not less than 3.5 g/dl.
- Women of child-bearing potential must be practicing barrier or oral contraception for the duration of the study or documented as surgically sterile or one year post-menopausal.
- If female, be non-nursing, non-pregnant and have a negative serum or urine pregnancy test within two weeks of starting study.
- The subject must be informed of the investigational nature of this study and written informed consent obtained prior to enrollment in this study.
- The subject must be able to comprehend the study description and its nature as only a feasibility study.
Who cannot join
- Administration of Pegasys-ribavirin or ANY anti-viral drug therapy within 90 days prior to enrollment into study.
- Administration of any other investigational drugs within 90 days prior to enrollment into study.
- Clinically significant infection, other than HCV, defined as any acute or chronic viral, bacterial, or fungal infection, which requires specific therapy (Anti-infectious therapy must have been completed at least 14-days before entry into study) in order to make entry into the study possible.
- Patient infected with human immunodeficiency virus or has AIDS.
- A history of hypotensive episodes during dialysis which lead to early termination of the treatment in the 2 treatments prior to the start of study treatments.
- Patients who have received an ACE (angiotensin converting enzyme) inhibitor within the last 24 hours should not be treated. Patients receiving an ACE inhibitor may experience an anaphylactoid-like reaction, including hypotension associated with flushing, dyspnea, and bradycardia. Such reactions, if left untreated, may be life-threatening. The administration of ACE inhibitors also has been associated with the occurrence of tachycardia. Risk of an anaphylactoid-like reaction or tachycardia may be minimized by the temporary cessation of the administration of ACE inhibitors for 6 days or longer before initiating the treatment protocol.
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- Any known pre-existing medical condition that could interfere with the subject's participation in the entire protocol, including serious psychiatric disorders, CNS trauma or active seizure disorders requiring medication, poorly-controlled diabetes mellitus as indicated by an Hb-A1c > 8% within the two weeks prior to protocol initiation, significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe interdialytic hypotension, or significant arrhythmia).
- Subjects with ECG showing clinically significant abnormalities.
- Dementia or other cognitively-limiting disease processes which would make it difficult for the patient to articulate their clinical status.
- Prior blood transfusion for any reason within 3 months prior to enrollment into study.
- Recent history of bleeding or bleeding disorders that would likely require the restriction in use of heparin during study treatments.
- Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia, scleroderma, severe psoriasis).
- Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids or other immunoregulatory medications.
- Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 months. Subjects receiving methadone within the past year are also excluded.)
- Any cancer requiring systemic chemotherapy or radiotherapy.
- Any other condition that, in the opinion of the Principal Investigators, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Safety Study of the Aethlon Hemopurifier® in Chronic ESRD Patients With HCV Infection
Primary Objectives:
To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood purification.
Secondary Objectives:
To quantify the number of viral copies captured by the Aethlon Hemopurifier® during the first and last Hemopurifier treatments using elution methods developed by Aethlon Medical Inc.
To measure changes in viral load in patients before and after treatment with the Aethlon Hemopurifier®.
Read the detailed description
This will be a single-arm, sequential, controlled feasibility/safety study in which each subject will serve as his/her own control. The control period will be the week immediately preceding the use of the investigational device during which eligible subjects will undergo and be monitored during three standard intermittent dialysis sessions. Vital signs, blood chemistries, hematology, liver function and adverse events will be measured. On weeks two and three, patients will receive treatment with the Hemopurifier® three times per week coincident with their ongoing standard intermittent hemodialysis treatments. During these two weeks, subjects will be assessed for the same clinical parameters but with the addition of viral load determination by quantitative PCR before and after each treatment with the Hemopurifier®. Viral load will also be measured at follow-up prior to the start of a given subject's hemodialysis treatment.
- Conditions
- End Stage Renal Disease, Hepatitis C Infection
- Being tested
- Affinity plasmapheresis
- Keywords
- ESRD, Hepatitis C
- Medical subject headings
- Kidney Failure, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affinity plasmapheresisDevice
Also called Aethlon Medical Hemopurifier
Insert investigational affinity plasma filter into hemodialysis circuit during routine hemodialysis treatments.
| Study group | Role | What they receive |
|---|---|---|
| Hemopurifier | Experimental | Affinity plasmapheresis Receives: Device: Affinity plasmapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events
Measured: 30 days
Secondary outcomes (1)
Viral load reduction
Viral load will be measured before and after each treatment with the investigational device.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startDec 2014
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
Why it stopped: Adequate safety data has been accumulated and the # of patients meeting inclusion criteria has diminished.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aethlon Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felicia B Ricks, RD CS-R LD, Study director, DaVita Clincal ResearchRonald Ralph, M. D. FASN, Principal investigator, Kidney Associates, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215902
- Sponsor's protocol ID
- AEMD - IDE - 2013
- Acronym
- AEMD-IDE-20
- Status last verified
- Mar 2017
- First submitted
- 12 Aug 2014
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Safety Study of the Aethlon Hemopurifier® in Chronic ESRD Patients With HCV Infection
- ClinicalTrials.gov ID
- NCT02215902
- Acronym / sponsor ID
- AEMD-IDE-20 / AEMD - IDE - 2013
- Conditions
- End Stage Renal Disease, Hepatitis C Infection
- Keywords
- ESRD, Hepatitis C
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Adequate safety data has been accumulated and the # of patients meeting inclusion criteria has diminished.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Aethlon Medical Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 13 Aug 2014 (estimated)
- 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.
Primary Objectives:
To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood purification.
Secondary Objectives:
To quantify the number of viral copies captured by the Aethlon Hemopurifier® during the first and last Hemopurifier treatments using elution methods developed by Aethlon Medical Inc.
To measure changes in viral load in patients before and after treatment with the Aethlon Hemopurifier®.
Detailed description
This will be a single-arm, sequential, controlled feasibility/safety study in which each subject will serve as his/her own control. The control period will be the week immediately preceding the use of the investigational device during which eligible subjects will undergo and be monitored during three standard intermittent dialysis sessions. Vital signs, blood chemistries, hematology, liver function and adverse events will be measured. On weeks two and three, patients will receive treatment with the Hemopurifier® three times per week coincident with their ongoing standard intermittent hemodialysis treatments. During these two weeks, subjects will be assessed for the same clinical parameters but with the addition of viral load determination by quantitative PCR before and after each treatment with the Hemopurifier®. Viral load will also be measured at follow-up prior to the start of a given subject's hemodialysis treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemopurifier | Experimental | Device: Affinity plasmapheresisAffinity plasmapheresis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males or females 18 years of age and older.
- Positive test for HCV infection (any genotype).
- End-stage-renal disease (ESRD) requiring dialysis - already established on HD.
- The arteriovenous fistula, graft or central venous catheter must have been functioning adequately for at least 1 month before entry into study showing no signs of infection or blockage.
- Have recovered from the toxicity of any prior systemic therapy.
Key exclusion criteria (16 listed)
- Administration of Pegasys-ribavirin or ANY anti-viral drug therapy within 90 days prior to enrollment into study.
- Administration of any other investigational drugs within 90 days prior to enrollment into study.
- Clinically significant infection, other than HCV, defined as any acute or chronic viral, bacterial, or fungal infection, which requires specific therapy (Anti-infectious therapy must have been completed at least 14-days before entry into study) in order to make entry into the study possible.
- Patient infected with human immunodeficiency virus or has AIDS.
- A history of hypotensive episodes during dialysis which lead to early termination of the treatment in the 2 treatments prior to the start of study treatments.
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 |
|---|---|---|
| Affinity plasmapheresisAlso: Aethlon Medical HemopurifierInsert investigational affinity plasma filter into hemodialysis circuit during routine hemodialysis treatments. | Device | Hemopurifier |
Primary outcome
Rate of adverse events
Time frame: 30 days
1 secondary outcome
Viral load reduction
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Adequate safety data has been accumulated and the # of patients meeting inclusion criteria has diminished.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Felicia B Ricks, RD CS-R LD study director
DaVita Clincal Research
Ronald Ralph, M. D. FASN principal investigator
Kidney Associates, PLLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affinity plasmapheresis in people with End Stage Renal Disease and Hepatitis C Infection, run by Aethlon Medical Inc. 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 16 inclusion and 16 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: stopped early, as of the sponsor's last update on 14 Mar 2017. 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. 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?
The study was stopped early (reason given: Adequate safety data has been accumulated and the # of patients meeting inclusion criteria has diminished.). 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?
Rate of adverse events (time frame: 30 days). 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 14 Mar 2017.