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A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury

A Uremic Toxin Absorbent (AST-120) to Treat Hospital Acquired Acute Kidney Injury - A Open Label Randomized Control Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02687841
Enrollment
206
Registered
2016-02-22
Start date
2016-01-31
Completion date
2017-12-31
Last updated
2016-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

Keywords

acute kidney injury, indoxylsulfate, p-cresol, AST-120

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.

Interventions

DRUGAST-120and pentoxyphylline (PTX)

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.

DRUGpentoxyphylline (PTX)

pentoxyphylline 400mg QD PO x 10 days.

Sponsors

National Taiwan University Hospital, Yun-Lin Branch
CollaboratorOTHER
National Taiwan University Hospital Hsin-Chu Branch
CollaboratorOTHER
China Medical University Hospital
CollaboratorOTHER
Taoyuan General Hospital
CollaboratorOTHER_GOV
Taipei Medical University Hospital
CollaboratorOTHER
Chang Gung Memorial Hospital
CollaboratorOTHER
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Total recovery of kidney function, which is defined as less than 1.5 times pre-morbid creatinine levels on the 10th day of intervention.10 days

Secondary

MeasureTime frameDescription
Degree of serum creatinine elevation10 daysas calculated with ratios between highest serum creatinine and pre-morbid creatinine during study period
The degree of Indoxyl sulfate change on Day 10 (%)10 days
The degree of Indoxyl sulfate change on Day 5 (%)5 days
Needing renal replacement therapy on day 10.10 days
The degree of p-cresol change on Day 5 (%)5 days
Total recovery of serum creatinine on Day 55 daysdefined with less than 1.5 times elevation of pre-morbid plasma creatinine level.
The degree of p-cresol change on Day 10 (%)10 days

Countries

Taiwan

Contacts

Primary ContactTao-Min Huang
taominhuang@gmail.com0972655730
Backup ContactKWAN-DUN WU
0972651011

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026