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Trial record 37 of 110 for:    CALCIUM CATION

Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury

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ClinicalTrials.gov Identifier: NCT01400893
Recruitment Status : Terminated
First Posted : July 25, 2011
Results First Posted : August 29, 2017
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
CytoPherx, Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Kidney Injury
Intervention Device: SCD
Enrollment 134
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CRRT + SCD CRRT Alone
Hide Arm/Group Description

Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized

SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.

Patients with a diagnosis of acute kidney injury and multiorgan failure requiring CRRT will be randomized
Period Title: Overall Study
Started 69 65
Completed 42 38
Not Completed 27 27
Reason Not Completed
Death             27             21
Lost to Follow-up             0             6
Arm/Group Title CRRT + SCD CRRT Alone Total
Hide Arm/Group Description

Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.

SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.

Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized. Total of all reporting groups
Overall Number of Baseline Participants 69 65 134
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 65 participants 134 participants
57.2  (13.1) 53.5  (14.7) 55.4  (14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 65 participants 134 participants
Female
27
  39.1%
25
  38.5%
52
  38.8%
Male
42
  60.9%
40
  61.5%
82
  61.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 65 participants 134 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  21.7%
14
  21.5%
29
  21.6%
White
53
  76.8%
48
  73.8%
101
  75.4%
More than one race
1
   1.4%
2
   3.1%
3
   2.2%
Unknown or Not Reported
0
   0.0%
1
   1.5%
1
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 69 participants 65 participants 134 participants
69 65 134
1.Primary Outcome
Title The Primary Clinical Efficacy Endpoint in This Trial is All Cause Mortality Through 60 Days Post-randomization.
Hide Description

All cause mortality through day 60 post-randomization.

The outcome data reported here describe the mortality at Day 60 (primary endpoint) of the treated subjects which received the recommended ionized calcium (riCa) for ≥ 90% of treatment time.

Time Frame Day 60 following treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome data is reported for those subjects in which the calcium levels were maintained in the protocol's recommended range (≤0.4 mmol/L) for greater or equal to 90% of the therapy time.
Arm/Group Title CRRT + SCD CRRT Alone
Hide Arm/Group Description:

Patients with a diagnosis of AKI requires CRRT will be randomized

SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.

Patients with a diagnosis of AKI requires CRRT will be randomized
Overall Number of Participants Analyzed 19 27
Measure Type: Count of Participants
Unit of Measure: Participants
Alive
16
  84.2%
16
  59.3%
Dead
3
  15.8%
11
  40.7%
2.Secondary Outcome
Title Renal Replacement Therapy Dependency at Day 60.
Hide Description RRT dependency at day 60 is defined as patient not receiving any form of intermittent or continuous renal replacement therapy at 60 days post enrollment in the study with no plans for additional intermittent or continuous renal replacement therapy.
Time Frame Day 60 following treatment initiation
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol.
Arm/Group Title CRRT + SCD CRRT Alone
Hide Arm/Group Description:

Patients with a diagnosis of AKI will be randomized

SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.

Patients with a diagnosis of AKI will be randomized
Overall Number of Participants Analyzed 19 26
Measure Type: Count of Participants
Unit of Measure: Participants
3
  15.8%
15
  57.7%
Time Frame Up to 7 days of SCD treatment or control. This time frame differs from the primary outcome measure of 60 day mortality since therapy was provided up to 7 days of SCD treatment. The adverse events were captured only during SCD treatment times since device related events would occur at that time frame. ITT patients are included in this table.
Adverse Event Reporting Description

Trial results showed that a number of enrollees in the treated and control arms deviated from protocol requiring regional citrate anticoagulation due to a national shortage of injectable CaCl2. The Primary Outcome is reported for patients who were treated per protocol.

Two subjects enrolled to CRRT alone arm were not treated, so not counted in SAEs. 60 Day Mortality does not include 6 subjects LTFU.

Other Adverse Events were not collected.

 
Arm/Group Title CRRT + SCD CRRT Alone
Hide Arm/Group Description

Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.

SCD: The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.

Patients with a diagnosis acute kidney injury with multiorgan failure requiring CRRT will be randomized.
All-Cause Mortality
CRRT + SCD CRRT Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   27/69 (39.13%)      21/59 (35.59%)    
Show Serious Adverse Events Hide Serious Adverse Events
CRRT + SCD CRRT Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/69 (65.22%)      40/63 (63.49%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders  1  8/69 (11.59%)  8 3/63 (4.76%)  3
Cardiac disorders     
Cardiac disorders  1  12/69 (17.39%)  12 10/63 (15.87%)  10
Gastrointestinal disorders     
Gastrointestinal disorders  1  4/69 (5.80%)  4 6/63 (9.52%)  6
General disorders     
General disorders and administration site conditions  1  4/69 (5.80%)  4 7/63 (11.11%)  7
Infections and infestations     
Infections and infestations  1  12/69 (17.39%)  12 10/63 (15.87%)  10
Injury, poisoning and procedural complications     
Injury, poisoning and procedural conplications  1  1/69 (1.45%)  1 0/63 (0.00%)  0
Investigations     
Investigations  1  0/69 (0.00%)  0 1/63 (1.59%)  1
Metabolism and nutrition disorders     
Metabolism and nutrition disorders  1  2/69 (2.90%)  2 2/63 (3.17%)  2
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue disorders  1  1/69 (1.45%)  1 1/63 (1.59%)  1
Psychiatric disorders     
Psychiatric disorders  1  0/69 (0.00%)  0 1/63 (1.59%)  1
Renal and urinary disorders     
Renal and urinary disorders  1  1/69 (1.45%)  1 3/63 (4.76%)  3
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders  1  10/69 (14.49%)  10 10/63 (15.87%)  10
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders  1  0/69 (0.00%)  0 2/63 (3.17%)  2
Vascular disorders     
Vascular disorders  1  7/69 (10.14%)  7 4/63 (6.35%)  4
1
Term from vocabulary, ITT patients
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CRRT + SCD CRRT Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: H. David Humes
Organization: CytoPherx, Inc
Phone: 734-997-7055 ext 302
EMail: dhumes@cytopherx.com
Layout table for additonal information
Responsible Party: CytoPherx, Inc
ClinicalTrials.gov Identifier: NCT01400893     History of Changes
Other Study ID Numbers: SCD-003
First Submitted: July 21, 2011
First Posted: July 25, 2011
Results First Submitted: March 14, 2017
Results First Posted: August 29, 2017
Last Update Posted: September 27, 2017