Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device

NCT01210716 | Completed Phase 3 Results

• 1 other identifier: FCRP- 0210
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

Brief Summary

This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.

Conditions

Autoimmune Diseases; Renal Disorders; Hematologic Disorders; Oncologic Disorders

Keywords

Therapeutic plasma exchange; Autoimmune diseases; Kidney transplant; Hematologic disorders; Monoclonal gammopathy; Neurologic disorders

Outcome Measures

Primary Outcomes (1)

• 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

  After completion of the TPE procedure.

Secondary Outcomes (1)

• Safety Measured by Adverse Events During the TPE Procedure

  Adverse events were collected during each TPE procedure.

Study Arms (2)

AMICUS Therapeutic plasma exchange, TPE

EXPERIMENTAL

Patients are randomized to either TPE on AMICUS or Spectra.

Device: Therapeutic plasma exchange

Spectra Therapeutic plasma exchange, TPE

ACTIVE COMPARATOR

Patients are randomized to either TPE on AMICUS or Spectra.

Device: Therapeutic plasma exchange

Interventions

Therapeutic plasma exchange DEVICE

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

AMICUS Therapeutic plasma exchange, TPE; Spectra Therapeutic plasma exchange, TPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fenwal, Inc.: lead

Study Sites (4)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

BloodCenter of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Autoimmune Diseases; Kidney Diseases; Hematologic Diseases; Paraproteinemias; Nervous System Diseases

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Immune System Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemic and Lymphatic Diseases; Blood Protein Disorders; Immunoproliferative Disorders

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Results Point of Contact

• Title: Sr. Mgr. Clinical Affairs
• Organization: Fenwal, Inc

carrie.pineda@fenwalinc.com

847-550-5620

Study Officials

• Peyton Metzel, PhD

  Fenwal, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2010
• First Posted: September 28, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 23, 2013
• Results First Posted: September 23, 2013

Record last verified: 2013-09

Locations

US (4)