Clinical trial NCT02687841: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Kidney Injury
Keywords: acute kidney injury
indoxylsulfate
p-cresol
AST-120
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University Hospital, Yun-Lin Branch
name: National Taiwan University Hospital Hsin-Chu Branch
name: China Medical University Hospital
name: Taoyuan General Hospital
name: Taipei Medical University Hospital
name: Chang Gung Memorial Hospital
First posted: 2016-02-22
Enrollment: 206
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

1. Age ≥ 20 years old on the day of admission
2. 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:

1. Baseline estimated glomerular filtration rates (eGFR) less than 30ml/min/1.73m2 or greater than 90ml/min/1.73m2 according to MDRD equation.
2. Acute kidney injury diagnosed in the indexed admission (according to baseline creatinine)
3. Ileus or under fasting status
4. Previous gastrointestinal operation.
5. 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.
6. Patients had ever undergone any modality of renal replacement therapy (RRT)
7. Patients with major hemorrhage, as defined with requirement of blood transfusion during index admission.
8. Patients with a biopsy proved or clinically diagnosed liver cirrhosis, Child classification B or C.
9. Patients with a congestive heart failure of NYHA Class III or IV, or requirement of inotropic agents.
10. Patients with a chronic lung disease requiring non-invasive or invasive positive pressure ventilation.
11. Solid organ or hematological transplantation donors.
12. Patients who had been diagnosed as AKI in the index hospitalization, as defined with KDIGO 2012 criteria.
13. Patients with oliguric acute kidney injury, as defined with less than 500cc/day.
14. Evidence of obstructive acute kidney injury under kidney echosonography.

Primary outcomes:
measure: Total recovery of kidney function, which is defined as less than 1.5 times pre-morbid creatinine levels on the 10th day of intervention.
timeFrame: 10 days
Secondary outcomes:
measure: Total recovery of serum creatinine on Day 5
timeFrame: 5 days
measure: Needing renal replacement therapy on day 10.
timeFrame: 10 days
measure: Degree of serum creatinine elevation
timeFrame: 10 days
measure: The degree of Indoxyl sulfate change on Day 10 (%)
timeFrame: 10 days
measure: The degree of Indoxyl sulfate change on Day 5 (%)
timeFrame: 5 days
measure: The degree of p-cresol change on Day 10 (%)
timeFrame: 10 days
measure: The degree of p-cresol change on Day 5 (%)
timeFrame: 5 days
Other outcomes:
Locations:
city: Douliou
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
Study officials:
affiliation: National Taiwan University Hospital
name: YU-SHENG WU
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Tao-Min Huang
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Wei-Shun Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Taoyuan General Hospital
name: JUI-HSIANG LIN
role: PRINCIPAL_INVESTIGATOR
affiliation: China Medical University Hospital
name: Ya-Fei Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Chan-Yu Lin
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Heng-Chih Pan
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Medical University Hospital
name: Chih-Chin Kao
role: PRINCIPAL_INVESTIGATOR
References: