Autoimmune DiseasesPhase 3NCT01210716
Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
A Phase 3 study testing Therapeutic plasma exchange in people with Autoimmune Diseases and Renal Disorders, run by Fenwal, Inc. at 4 sites in United States.
Trial summary
This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Renal Disorders, Hematologic Disorders
- What is being tested?
- Therapeutic plasma exchange
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2010to May 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Medically stable patients undergoing more than one TPE procedure who have provided signed informed consent prior to participation.
- A physician's prescription for TPE for various non-emergent conditions.
- Test and Control TPE procedures that would be expected to be completed within approximately five weeks.
Who cannot join
- Patients under 18 years old.
- Patients on an ACE inhibitor medication should discontinue use of this medication in accordance with institutional practices.
- Patients with altered mental status that would prohibit the giving and understanding of informed consent.
- Patients who have experienced a serious adverse event associated with the first TPE clinical study procedure.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia
Charlottesville, Virginia, 22903
BloodCenter of Wisconsin
Milwaukee, Wisconsin, 53226
Yale University School of Medicine
New Haven, Connecticut, 06520
Mayo Clinic
Rochester, Minnesota, 55905
About this study
This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.
Read the detailed description
Therapeutic plasma exchange (TPE) is intended for efficient removal of circulating plasma, with the return of replacement fluids to the patient. In the majority of cases, the treatment goal is to selectively remove the substance directly responsible for the patient's disease process.
Fenwal's AMICUS separator platform is a centrifuge-based apheresis system which collects the blood components of interest and returns the remaining blood components along with saline back to a donor/patient. The device has been cleared for the following:
- The collection of platelets and plasma in Japan, Europe and the US (BK960005), 1996.
- The collection of mononuclear cells (MNCs) in the US (BK000047), 2002.
- The collection of a concurrent red blood cell (cRBC) product collected in ACD-A anticoagulant and stored in ADSOL® Preservation Solution (BK000039), 2002.
Fenwal has developed a new protocol on the AMICUS separator that enables the device to perform TPE procedures. The procedure is similar to the FDA cleared platelet and concurrent plasma collections, except that in TPE procedures the majority of plasma is retained and the red blood cells (RBCs), white blood cells (WBC) and the majority of the platelets are returned to the patient.
- Being tested
- Therapeutic plasma exchange
- Keywords
- Therapeutic plasma exchange, Autoimmune diseases, Kidney transplant, Hematologic disorders, Monoclonal gammopathy, Neurologic disorders
- Medical subject headings
- Autoimmune Diseases, Kidney Diseases, Hematologic Diseases, Paraproteinemias, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic plasma exchangeDevice
Also called TPE
Patients are randomized to either Therapeutic plasma exchange procedures on AMICUS or Spectra first. The second procedure (based on time interval determined by physician) will be completed on the other instrument.
| Study group | Role | What they receive |
|---|---|---|
| AMICUS Therapeutic plasma exchange, TPE | Experimental | Patients are randomized to either TPE on AMICUS or Spectra. Receives: Device: Therapeutic plasma exchange |
| Spectra Therapeutic plasma exchange, TPE | Active comparator | Patients are randomized to either TPE on AMICUS or Spectra. Receives: Device: Therapeutic plasma exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure
The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure.
Plasma Efficiency = (plasma removed/plasma processed)*100
Measured: After completion of the TPE procedure.
Secondary outcomes (1)
Safety Measured by Adverse Events During the TPE Procedure
Measured: Adverse events were collected during each TPE procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autoimmune DiseasesStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenwal, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peyton Metzel, PhD, Study chair, Fenwal, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210716
- Sponsor's protocol ID
- FCRP- 0210
- Status last verified
- Sep 2013
- First submitted
- 26 Sep 2010
- Last updated
- 23 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
- ClinicalTrials.gov ID
- NCT01210716
- Acronym / sponsor ID
- FCRP- 0210
- Keywords
- Therapeutic plasma exchange, Autoimmune diseases, Kidney transplant, Hematologic disorders, Monoclonal gammopathy, Neurologic disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Fenwal, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Posted 23 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.
Detailed description
Therapeutic plasma exchange (TPE) is intended for efficient removal of circulating plasma, with the return of replacement fluids to the patient. In the majority of cases, the treatment goal is to selectively remove the substance directly responsible for the patient's disease process.
Fenwal's AMICUS separator platform is a centrifuge-based apheresis system which collects the blood components of interest and returns the remaining blood components along with saline back to a donor/patient. The device has been cleared for the following:
- The collection of platelets and plasma in Japan, Europe and the US (BK960005), 1996.
- The collection of mononuclear cells (MNCs) in the US (BK000047), 2002.
- The collection of a concurrent red blood cell (cRBC) product collected in ACD-A anticoagulant and stored in ADSOL® Preservation Solution (BK000039), 2002.
Fenwal has developed a new protocol on the AMICUS separator that enables the device to perform TPE procedures. The procedure is similar to the FDA cleared platelet and concurrent plasma collections, except that in TPE procedures the majority of plasma is retained and the red blood cells (RBCs), white blood cells (WBC) and the majority of the platelets are returned to the patient.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMICUS Therapeutic plasma exchange, TPE | Experimental | Device: Therapeutic plasma exchangePatients are randomized to either TPE on AMICUS or Spectra. |
| Spectra Therapeutic plasma exchange, TPE | Active comparator | Device: Therapeutic plasma exchangePatients are randomized to either TPE on AMICUS or Spectra. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medically stable patients undergoing more than one TPE procedure who have provided signed informed consent prior to participation.
- A physician's prescription for TPE for various non-emergent conditions.
- Test and Control TPE procedures that would be expected to be completed within approximately five weeks.
Key exclusion criteria (4 listed)
- Patients under 18 years old.
- Patients on an ACE inhibitor medication should discontinue use of this medication in accordance with institutional practices.
- Patients with altered mental status that would prohibit the giving and understanding of informed consent.
- Patients who have experienced a serious adverse event associated with the first TPE clinical study procedure.
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 |
|---|---|---|
| Therapeutic plasma exchangeAlso: TPEPatients are randomized to either Therapeutic plasma exchange procedures on AMICUS or Spectra first. The second procedure (based on time interval determined by physician) will be completed on the other instrument. | Device | AMICUS Therapeutic plasma exchange, TPE, Spectra Therapeutic plasma exchange, TPE |
Primary outcome
Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure
Time frame: After completion of the TPE procedure.
The calculation is based on the volume of plasma that was processed through the machine compared to the volume of patient plasma that was actually removed during the procedure. Plasma Efficiency = (plasma removed/plasma processed)*100
1 secondary outcome
Safety Measured by Adverse Events During the TPE Procedure
Time frame: Adverse events were collected during each TPE procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peyton Metzel, PhD study chair
Fenwal, Inc.
4 sites 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 in people with Autoimmune Diseases and Renal Disorders, run by Fenwal, Inc. at 4 sites 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 23 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Yes. Results are posted in the registry (first posted 23 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure (time frame: After completion of the TPE procedure.). 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 2013.