Back to resultsA Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury
Primary Purpose
Acute Kidney Injury
Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
AST-120and pentoxyphylline (PTX)
pentoxyphylline (PTX)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Kidney Injury focused on measuring acute kidney injury, indoxylsulfate, p-cresol, AST-120
Eligibility Criteria
This is a prospective randomized placebo controlled trial. All patients admitted to participating centers with newly diagnosed acute kidney injury (AKI) will be screened for eligibility. The diagnosis of AKI will be determined and staged according to the KIGO-AKI Guideline.11 The inclusion criteria include:
- Age ≥ 20 years old on the day of admission
- AKI develops during admission, as defined with KDIGO-AKI Guideline,11 namely, elevation of serum creatinine above 0.3mg/dL within two days, above 1.5times baseline.
Patients with the following conditions will be excluded:
- Baseline estimated glomerular filtration rates (eGFR) less than 30ml/min/1.73m2 or greater than 90ml/min/1.73m2 according to MDRD equation.
- Acute kidney injury diagnosed in the indexed admission (according to baseline creatinine)
- Ileus or under fasting status
- Previous gastrointestinal operation.
- Chronic constipation, as defined with bowel movement less than three times a day. If usage of oral laxatives can achieve bowel movement of more than 3 times a day, this patient will not be excluded.
- Patients had ever undergone any modality of renal replacement therapy (RRT)
- Patients with major hemorrhage, as defined with requirement of blood transfusion during index admission.
- Patients with a biopsy proved or clinically diagnosed liver cirrhosis, Child classification B or C.
- Patients with a congestive heart failure of NYHA Class III or IV, or requirement of inotropic agents.
- Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.
- Solid organ or hematological transplantation donors.
- Patients who had been diagnosed as AKI in the index hospitalization, as defined with KDIGO 2012 criteria.
- Patients with oliguric acute kidney injury, as defined with less than 500cc/day.
- Evidence of obstructive acute kidney injury under kidney echosonography.
Sites / Locations
- National Taiwan University Hospital Yun-Lin BranchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AST-120 and PTX
PTX
Arm Description
AST-120 2g 4 times a day for 5 days then AST-120 2g 3 times a day for 5 days Pentapentoxifylline 400mg QD for 10 days
Pentapentoxifylline 400mg QD for 10 days
Outcomes
Primary Outcome Measures
Total recovery of kidney function, which is defined as less than 1.5 times pre-morbid creatinine levels on the 10th day of intervention.
Secondary Outcome Measures
Total recovery of serum creatinine on Day 5
defined with less than 1.5 times elevation of pre-morbid plasma creatinine level.
Needing renal replacement therapy on day 10.
Degree of serum creatinine elevation
as calculated with ratios between highest serum creatinine and pre-morbid creatinine during study period
The degree of Indoxyl sulfate change on Day 10 (%)
The degree of Indoxyl sulfate change on Day 5 (%)
The degree of p-cresol change on Day 10 (%)
The degree of p-cresol change on Day 5 (%)
Full Information
NCT ID
NCT02687841
First Posted
January 26, 2016
Last Updated
February 17, 2016
Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University Hospital Hsin-Chu Branch, China Medical University Hospital, Taoyuan General Hospital, Taipei Medical University Hospital, Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02687841
Brief Title
A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury
Official Title
A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury - A Open Label Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Taiwan University Hospital, Yun-Lin Branch, National Taiwan University Hospital Hsin-Chu Branch, China Medical University Hospital, Taoyuan General Hospital, Taipei Medical University Hospital, Chang Gung Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hospital acquired acute kidney injury is an important negative outcome predictor for hospitalized patients. Uremic toxins accumulated after a given renal insult. Some of these uremic toxins are protein bound and may accumulated after renal impairment, owing to both impaired filtration, and inflammation. Recent animal studies have reported that accumulation of uremic toxins, namely indoxyl sulfate and p-cresol, would down regulate endothelial progenitor cells and in turn affect renal recovery. Elimination of these protein bound uremic toxins with an activated charcoal would help restore endothelial function. We will conduct a double blinded randomized placebo controlled trial, which aims to determine that if oral activated charcoal will retard progression of AKI. Also, a panel of markers for endothelial function will also be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
acute kidney injury, indoxylsulfate, p-cresol, AST-120
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AST-120 and PTX
Arm Type
Experimental
Arm Description
AST-120 2g 4 times a day for 5 days then AST-120 2g 3 times a day for 5 days Pentapentoxifylline 400mg QD for 10 days
Arm Title
PTX
Arm Type
Active Comparator
Arm Description
Pentapentoxifylline 400mg QD for 10 days
Intervention Type
Drug
Intervention Name(s)
AST-120and pentoxyphylline (PTX)
Intervention Description
AST-120 2g 4 times a day for 5 days then AST-120 2g 3 times a day for 5 days pentoxyphylline 400mg QD PO x 10 days.
Intervention Type
Drug
Intervention Name(s)
pentoxyphylline (PTX)
Intervention Description
pentoxyphylline 400mg QD PO x 10 days.
Primary Outcome Measure Information:
Title
Total recovery of kidney function, which is defined as less than 1.5 times pre-morbid creatinine levels on the 10th day of intervention.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Total recovery of serum creatinine on Day 5
Description
defined with less than 1.5 times elevation of pre-morbid plasma creatinine level.
Time Frame
5 days
Title
Needing renal replacement therapy on day 10.
Time Frame
10 days
Title
Degree of serum creatinine elevation
Description
as calculated with ratios between highest serum creatinine and pre-morbid creatinine during study period
Time Frame
10 days
Title
The degree of Indoxyl sulfate change on Day 10 (%)
Time Frame
10 days
Title
The degree of Indoxyl sulfate change on Day 5 (%)
Time Frame
5 days
Title
The degree of p-cresol change on Day 10 (%)
Time Frame
10 days
Title
The degree of p-cresol change on Day 5 (%)
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
This is a prospective randomized placebo controlled trial. All patients admitted to participating centers with newly diagnosed acute kidney injury (AKI) will be screened for eligibility. The diagnosis of AKI will be determined and staged according to the KIGO-AKI Guideline.11 The inclusion criteria include:
Age ≥ 20 years old on the day of admission
AKI develops during admission, as defined with KDIGO-AKI Guideline,11 namely, elevation of serum creatinine above 0.3mg/dL within two days, above 1.5times baseline.
Patients with the following conditions will be excluded:
Baseline estimated glomerular filtration rates (eGFR) less than 30ml/min/1.73m2 or greater than 90ml/min/1.73m2 according to MDRD equation.
Acute kidney injury diagnosed in the indexed admission (according to baseline creatinine)
Ileus or under fasting status
Previous gastrointestinal operation.
Chronic constipation, as defined with bowel movement less than three times a day. If usage of oral laxatives can achieve bowel movement of more than 3 times a day, this patient will not be excluded.
Patients had ever undergone any modality of renal replacement therapy (RRT)
Patients with major hemorrhage, as defined with requirement of blood transfusion during index admission.
Patients with a biopsy proved or clinically diagnosed liver cirrhosis, Child classification B or C.
Patients with a congestive heart failure of NYHA Class III or IV, or requirement of inotropic agents.
Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.
Solid organ or hematological transplantation donors.
Patients who had been diagnosed as AKI in the index hospitalization, as defined with KDIGO 2012 criteria.
Patients with oliguric acute kidney injury, as defined with less than 500cc/day.
Evidence of obstructive acute kidney injury under kidney echosonography.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao-Min Huang
Phone
0972655730
Email
taominhuang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
KWAN-DUN WU
Phone
0972651011
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YU-SHENG WU
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tao-Min Huang
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei-Shun Yang
Organizational Affiliation
National Taiwan University Hospital Hsin-Chu Branch
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JUI-HSIANG LIN
Organizational Affiliation
Taoyuan General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ya-Fei Yang
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chan-Yu Lin
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heng-Chih Pan
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chih-Chin Kao
Organizational Affiliation
Taipei Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital Yun-Lin Branch
City
Douliou
ZIP/Postal Code
640
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao-Min Huang
Phone
0972655730
Email
taominhuang@gmail.com
12. IPD Sharing Statement
Learn more about this trial
A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury
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