A Phase 3 interventional study of Therapeutic plasma exchange in Autoimmune Diseases, Renal Disorders and Hematologic Disorders, sponsored by Fenwal, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-23.
Sponsored by Fenwal, Inc. · Phase 3 and Interventional
This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.
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:
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 37 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Fenwal, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients are randomized to either TPE on AMICUS or Spectra.
Device: Therapeutic plasma exchange
Patients are randomized to either TPE on AMICUS or Spectra.
Device: Therapeutic plasma exchange
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.
Also known as: TPE
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
Time frame: After completion of the TPE procedure.
Safety Measured by Adverse Events During the TPE Procedure
Time frame: Adverse events were collected during each TPE procedure.
The study opened enrollment on Sept 2010 at three hospitals-Yale New Haven Hospital, Mayo Clinic and University of Virginia Health System. A 4th site, BloodCenter of Wisconsin opened enrollment April,2011.
| Milestone | Spectra First, Then AMICUS | AMICUS First, Then Spectra |
|---|---|---|
| Started | 20 | 17 |
| Completed | 18 | 15 |
| Not completed | 2 | 2 |
| Milestone | Spectra First, Then AMICUS | AMICUS First, Then Spectra |
|---|---|---|
| Started | 18 | 15 |
| Completed | 15 | 15 |
| Not completed | 3 | 0 |
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
| percentage of plasma removal efficiency | AMICUS (Test) | Spectra (Control) |
|---|---|---|
| Percent Efficiency of Plasma Removal During the Therapeutic Plasma Exchange Procedure | 81.9 (68 to 96) | 75.2 (61 to 88) |
| participants | Overall Study Population |
|---|---|
| Safety Measured by Adverse Events During the TPE Procedure | 7 (61 to 88) |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Study Population | — | 0/37 (0%) | 7/37 (18.9%) |
| Event | Overall Study Population |
|---|---|
| ParesthesiaNervous system disorders | 3/37 |
| Dizzy/Light-HeadedNervous system disorders | 2/37 |
| NauseaGastrointestinal disorders | 1/37 |
| FatigueGeneral disorders | 1/37 |
| InfiltrationSkin and subcutaneous tissue disorders | 1/37 |
| ChillsNervous system disorders | 1/37 |
| HeadacheNervous system disorders | 1/37 |
| RigorsMusculoskeletal and connective tissue disorders | 1/37 |
Demographics were reported for the evaluable patient population.
| Age, Categorical(Participants) | Overall Study Population |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 25 |
| >=65 years | 5 |
| Age Continuous(years) | Overall Study Population |
|---|---|
| Mean | 50.7 ± 13.7 |
| Sex: Female, Male(Participants) | Overall Study Population |
|---|---|
| Female | 15 |
| Male | 15 |
| Region of Enrollment(participants) | Overall Study Population |
|---|---|
| United States | 30 |
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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