Efficacy and Safety of Plasma Exchange With Albumin in Pa... | NCT02479802

NCT02479802

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Albumin	Experimental	Plasma exchange with Albumin	Biological: Albumin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Albumin	Biological	27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution: three weeks of intensive treatment with two plasma exchanges per week twenty-one weeks of maintenance treatment with one weekly plasma exchange

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)	Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) includes 12 questions classified into 3 subdomains: bulbar function (3 questions), fine and gross motor skills (6 questions), and respiratory function (3 questions) to assess the level self sufficiency. Each task was graded according to a 5-point scale from 0 (incapable) to 4 (normal ability) with a total score from 0 (worst) to 48 (best).	Baseline, Weeks 4, 12, 25, 36, and 48
Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)		Baseline, Weeks 4, 12, 25, 36, and 48

Secondary Outcomes

Measure	Description	Time Frame
Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test	ALS-CBS test is composed of 2 sections. The first section of the ALS-CBS test includes a questionnaire completed by the caregiver regarding behavior and symptoms status. It is comprised of 15 questions inquiring about possible changes over time in participant's behavior that the caregiver has noticed since the onset of ALS symptoms. Each item is scored on a scale ranging from 0 (worst) to 3 (best) yielding a total 0= large changes to 45=no changes. There were 4 additional questions related to current behavioral symptoms (depression, anxiety, fatigue, and emotional liability). Each question was scored as 0= the presence of symptoms and 1= no current symptoms, giving a total score between 0 and 4. The second section of the ALB-CBS test is for cognitive screening and consists of four items: attention, concentration, follow-up and monitoring, and initiation and recovery. These items were scored 0-5 with a maximum score of 20 (0= cognitive impairment, 20= no apparent cognitive impairment).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written-informed consent.
Subjects over 18 years of age, and less than 70 years old.
Subjects with a definite, possible, or probable diagnosis of ALS, according to the revised El Escorial criteria.
Subjects having experienced their first ALS symptoms within 18 months before recruitment/consent.
FVC > 70%
Subjects must be medically suitable for study participation and of complying with all planned aspects of the protocol including blood sampling at the time of inclusion in the study.

Exclusion Criteria:

Subjects with a clinically significant preexisting lung disease not attributable to ALS.
Subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of ALS.
Participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study.
Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
Difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol
Any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team
A history of frequent adverse reactions (serious or otherwise) to blood products.
Hypersensitivity to albumin or allergies to any of the components of Albutein.
Subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoagulants
Plasma creatinine > 2mg/dl.
Present a history of heart disease including ischemic heart disease or congestive heart failure.
Presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment
Any condition that complicates adherence to study protocol (illness with less than one year of expected survival, drug or alcohol abuse, etc.)

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Bellvitge		L'Hospitalet de Llobregat	Barcelona	08907	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34791571	Derived	Povedano M, Paipa A, Barcelo M, Woodward MK, Ortega S, Dominguez R, Aragones ME, Horrillo R, Costa M, Paez A. Plasma exchange with albumin replacement and disease progression in amyotrophic lateral sclerosis: a pilot study. Neurol Sci. 2022 May;43(5):3211-3221. doi: 10.1007/s10072-021-05723-z. Epub 2021 Nov 18.

ID	Title	Description
FG000	Albumin	Plasma exchange with Albumin Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution: three weeks of intensive treatment with two plasma exchanges per week twenty-one weeks of maintenance treatment with one weekly plasma exchange

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Albumin	Plasma exchange with Albumin Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution: three weeks of intensive treatment with two plasma exchanges per week twenty-one weeks of maintenance treatment with one weekly plasma exchange

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) includes 12 questions classified into 3 subdomains: bulbar function (3 questions), fine and gross motor skills (6 questions), and respiratory function (3 questions) to assess the level self sufficiency. Each task was graded according to a 5-point scale from 0 (incapable) to 4 (normal ability) with a total score from 0 (worst) to 48 (best).

Two subjects discontinued from the study early.

Posted

Median

Inter-Quartile Range

units on a scale

Baseline, Weeks 4, 12, 25, 36, and 48

ID	Title	Description
OG000	Albumin	Plasma exchange with Albumin Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution: three weeks of intensive treatment with two plasma exchanges per week twenty-one weeks of maintenance treatment with one weekly plasma exchange

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Albumin	Plasma exchange with Albumin Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution: three weeks of intensive treatment with two plasma exchanges per week twenty-one weeks of maintenance treatment with one weekly plasma exchange

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease

ID	Term
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins